Sa dr žaj/Contents

1. Uvod1. Introduction2. ALIMS - or ga ni za ci ja ko ja se kon ti nu i ra no raz vi ja i una pre đu je ..............................................2. ALIMS - an organization that is continually evolving and improving.................................................

2.1. Mi si ja i vi zi ja ALIMS ..............................................................................................................2.1. Mission and Vision of ALIMS ........................................................................................................2.2. Or ga ni za ci ja ALIMS ..............................................................................................................2.2. ALIMS Organization ........................................................................................................................2.3. Isto ri jat i po ve re ni po slo vi ...................................................................................................2.3. Background and entrusted activities ..........................................................................................2.4. Ljud ski re sur si .......................................................................................................................2.4. Human Resources ...........................................................................................................................2.5. Me đu na rod na sa rad nja i član stvo u me đu na rod nim or ga ni za ci ja ma ....................2.5. International cooperation and membership in international organizations ....................2.6. Ci lje vi raz vo ja .........................................................................................................................2.6. Development Goals .....................................................................................................................

3. Re gu la tor na pe r for man sa ALIMS .....................................................................................................3. ALIMS Regulatory Performance ...................................................................................................................

3.1. Pred re gi stra ci o ne ak tiv no sti ...............................................................................................3.1. Pre-registration activities ...............................................................................................................3.2. Me di cin ska sred stva ............................................................................................................3.2. Medical devices ................................................................................................................................3.3. Ve te ri nar ski le ko vi ................................................................................................................3.3. Veterinary medicines ......................................................................................................................3.4. Po stre gi stra ci o ne ak tiv no sti: fa r ma ko vi gi lan ca, in for ma ci je o le ko vi ma,

pra će nje po tro šnje i pro me ta, ogla ša va nje ....................................................................3.4. Post-registration activities: pharmacovigilance, information about medicines,

monitoring of consumption and trade, advertising ................................................................3.5. Kli nič ka is pi ti va nja ................................................................................................................3.5. Clinical trials ......................................................................................................................................

4. La bo ra to rij ska kon tro la kva li te ta ......................................................................................................4. Laboratory quality control ..............................................................................................................................5. Upra vlja nje kva li te tom u ALIMS ........................................................................................................5. Quality Management in ALIMS ....................................................................................................................6. Struč ni sku po vi u or ga ni za ci ji ALIMS - edu ka ci ja struč ne jav no sti .........................................6. Professional meetings organized by ALIMS - education of expert public ........................................7. Pu bli ka ci je ALIMS ..................................................................................................................................7. ALIMS Publications ..........................................................................................................................................8. In ter net stra ni ca ALIMS .......................................................................................................................8. ALIMS Website .................................................................................................................................................

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1. Uvod

Kroz vreme, glavno opredeljenje čoveka je njegova briga za zdravlje i život, pa mu je u borbi za opstanak to bilo pokretač da ih sačuva. Rezultat

toga je razvoj lekova, kao i medicinskih sredstava u cilju lečenja ili sprečavanja bolesti, odnosno očuvanja života kod ljudi i životinja.Sada, brigu za očuvanje zdravlja i života delom preuzima Agencija za lekove i medicinska sredstva Srbije - ALIMS koja u skladu sa Zakonom o lekovima i medicinskim sredstvima („Službeni glasnik RS“, br. 30/2010 i 107/2012) i propisima donetim za njegovo sprovođenje, usaglašenim sa zahtevima i standardima Evropske unije donosi odluke o potvrdi kvaliteta, bezbednosti i efikasnosti lekova i medicinskih sredstava. Ozbiljnost i posvećenost sa kojom svi zaposleni u Agenciji pristupaju svojim radnim zadacima je u skladu sa nivoom odgovornosti u donošenju navedenih odluka Agencije. Takođe, u propisanoj kontroli kvaliteta lekova i medicinskih sredstava Agencija svakodnevno donosi odluke da li se ispunjavaju standardi u odnosu na njihov kvalitet, a koji su i standardi najrazvijenih zemalja sveta, kojima se obezbeđuje sigurnost u primeni i korišćenju ovih proizvoda.Uspostavljeni sistem Agencije, testiran i u pojedinim teškim okolnostima pokazao je da građani Srbije mogu da imaju poverenje u odluke Agencije u odnosu na lekove i medicinska sredstva koja se nalaze na njenom tržištu.Posebna aktivnost Agencije je praćenje života leka na tržištu i eventualno preduzimanje korektivnih mera kako je to predviđeno našim propisima u oblasti farmakovigilance, koji su takođe usklađeni sa najnovijim EU standardima.U izvršavanju svojih poslova Agencija održava stalnu saradnju sa nadležnim državnim organima, fakultetima, profesionalnim udruženjima lekara, farmaceuta, stomatologa i veterinara, udruženjima pacijenata, medijima i opštom i stručnom javnošću.Takođe, Agencija u izvršavanju svojih poslova razvija visok nivo regionalne i međunarodne saradnje, a ima i podršku u svom razvoju od strane referentnih organizacija u Evropi i Svetu, što se ogleda i kroz veći broj projekata i postojanje međunarodnih ugovora u oblastima iz nadležnosti Agencije.Stavljanjem u promet lekova i medicinskih sredstava za koje su u propisanim postupcima dokazani kvalitet, bezbednost i efikasnost, su osnovni principi Agencije, kako bi se ostvarili ciljevi u odnosu na očuvanje zdravlja, produženje života i obezbeđenje njegovog kvaliteta.

Direktor

Spec. dr. med. Saša Jaćović

1. Introduction

Through time, the main orientation of man is his concern for his health and life, so in his struggle for survival this determination was a driving force to preserve them. The result of this is the development of medicines and medical devices, in order to treat or prevent

diseases, or preserve life in humans and animals.Now, obligation to preserve the health and life is taken in part by Medicines and Medical Devices Agency of Serbia - ALIMS, that in accordance with the Law on Medicines and Medical Devices (“Official Gazette of RS”, no. 30/2010 and 107/2012) and regulations adopted for its execution complies with the requirements and standards of the European Union gives decission to confirm the quality, safety and efficacy of medicines and medical devices. Seriousness and commitment with which all employees shall approach their work tasks in accordance with the level of responsibility in making these decisions by the Agency. Also, in the prescribed quality control of medicines and medical devices the Agency makes decisions every day in order to check if the standards in relation to their quality are met and these are the standards of most developed countries in the world, to ensure the security of the application of these products.The system established in the Agency was tested in some difficult circumstances and showed that Serbian citizens can have trust in the Agency’s decision in relation to medicines and medical devices that are within its market.A specific activity of the Agency is following the life cycle of the drug on the market and possibly taking corrective measures as provided in our regulations in the field of pharmacovigilance, that are also in compliance with the latest EU standards.In carrying out its duties the Agency maintains permanent cooperation with state authorities, universities, professional associations of doctors, pharmacists, dentists, veterinarians, patient organizations, the media and the general and professional public.Also, the Agency in carrying out its duties develops a high level of regional and international cooperation, and has support in its development by reference organization in Europe and the world, which is also reflected in a number of projects and the existence of international agreements in the areas the Agency is in charge of.Putting on the market medicines and medical devices for which quality, safety and efficiency are proved by prescribed procedures are the basic principles of the Agency, in order to achieve the objectives in relation to the preservation of health, extending life and securing its quality.

Managing Director

Sasa Jacovic, M. D., sp.

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2. ALIMS - or ga ni za ci ja ko ja se kon ti nu i ra no raz vi ja

i una pre đu je

2. ALIMS – an organization which is continually

developing and improving

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2.1. Mission and vision of ALIMSOur mission is to contribute to the accompli-shment of the basic human right for quality, efficacious and safe medicines and medical devices accessibility as well as to promote and enhance public and animal health through: • Issuingmarketing authorizations of sole-

ly quality, safe and efficacious medicinal products and medical devices,

• Providingadequateinformationinorderto ensure a safe and rational use of such me-dicinal products and medical devices, and

• Quality control ofmedicines andmedicaldevices which is in full compliance with all the national and international laws and standards.

Our vision is to be a modern, efficient and socially responsible institution which is to become a leading one in the SEE region.

2.1. Mi si ja i vi zi ja ALIMS

Na ša mi si ja je da do pri ne se mo ostva ri va nju osnov nog ljud skog pra va za pri stup kva li tet-nim, bez bed nim i efi ka snim le ko vi ma i me di-cin skim sred stvi ma, kao i da pro mo vi še mo i una pre di mo zdra vlje lju di i ži vo ti nja kroz:• izdavanje dozvola za stavljanje u promet

is klju či vo kva li tet nih, bez bed nih i efi ka snih le ko va i me di cin skih sred sta va,

• pružanje adekvatnih informacija, kako biupo tre ba tih le ko va i me di cin skih sred sta-va bi la bez bed na i ra ci o nal na i

• kontrolu kvaliteta lekova i medicinskihsred sta va, ko ja je u pot pu no sti usa gla še na sa svim na ci o nal nim i me đu na rod nim za-ko ni ma i stan dar di ma.

Na ša vi zi ja je da bu de mo mo der na, efi ka sna i dru štve no od go vor na in sti tu ci ja, ko ja će po-sta ti li der u re gi o nu ju go i stoč ne Evr o pe.

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We shall accomplish our vision through the effective and efficacious processes of the quality management system which is in conformity with the ISO 9001:2008 requirements, through: • Establishment and maintenance of high

level standards in a documentation evalu-ation procedure and quality control, and providing of adequate information,

• Continualstudiesandcompetencedevelo­pment,

• Continuous quality management systemimprovement,

• Development of a strong organizationalculture and recognizable image,

• Havingaleadingroleofthemanagementin the vision accomplishment.

Basic valuesWe believe we can meet all the challenges with our strength and stamina. Our performance is based on four basic principles:• Social responsibility – as an institution

we are firstly and mostly dedicated to hu-man and animal health protection so all our work, professional and scientific com-petence are devoted to patients in Serbia. We are responsible to our social environ-ment, users of our services, employees and founders.

• Leadership – we committed ourselves to setting high standards by our operation, to becoming a support to all the interested parties in respect of public health through knowledge and skills enhancement, as well as to ensuring a complete vision ac-complishment by modern management.

• Trust – our further development is based on enhancement of mutual trust between us and our clients through joint perfor-mance and work transparency as well as on strengthening the belief in ourselves, i.e. our employees.

• Quality – we are devoted to achieving the highest quality of our services so the ad-ditional value for our clients, partners and employees can be accomplished.

Na šu vi zi ju će mo ostva ri ti kroz efek tiv ne i efi-ka sne pro ce se u okvi ru si ste ma me nadž men-ta kva li te tom, usa gla še nog sa zah te vi ma ISO 9001:2008, ta ko što će mo:• uspostavljati iodržavativisokestandar­

de u po stup ku eva lu a ci je do ku men ta ci je, kon to li kva li te ta i pru ža nju ade kvat nih in for ma ci ja,

• kontinuirano učiti i razvijati kompetent­no sti,

• kontinuiranopoboljšavatisistemmenadž­men ta kva li te tom,

• izgraditi jaku organizacionu kulturu i pre­po zna tljiv imidž,

• imati liderskuulogu rukovodstvauostva­re nju vi zi je.

Osnovne vrednostiMi ve ru je mo da svo jom sna gom mo že mo da od go vo ri mo na sve iza zo ve. Naš rad je za-sno van na če ti ri osnov na prin ci pa:• dru štve na od go vor nost – kao in sti tu ci ja

na pr vom me stu i u naj ve ćoj me ri po sve će ni smo oču va nju zdra vlja lju di i ži vo ti nja, ta ko da sav svoj rad, struč nu i na uč nu kom pe-tent nost po sve ću je mo pa ci jen ti ma u Sr bi ji. Od go vor ni smo pre ma dru štve noj za jed ni-ci, ko ri sni ci ma na ših uslu ga, za po sle ni ma i osni va či ma.

• li der stvo – opre de li li smo se da svo jim ra dom po sta vlja mo vi so ke stan dar de, da una pre đe njem zna nja i ve šti na bu de mo oslo nac svim za in te re so va nim stra na ma, ka da je jav no zdra vlje u pi ta nju, kao i da mo der nim ru ko vo đe njem osi gu ra mo pot-pu no ostva re nje vi zi je.

• po ve re nje – naš da lji raz voj za sno van je na una pre đe nju me đu sob nog po ve re nja sa na šim kli jen ti ma, kroz za jed nič ki rad i tran-spa rent nost u ra du, kao i na ja ča nju po ve-re nja u nas sa me, od no sno u na še za po-sle ne.

• kva li tet – po sve će ni smo do sti za nju naj-vi šeg kva li te ta na ših uslu ga, ka ko bi se ostva ri la do dat na vred nost za na še ko ri-sni ke, pa rt ne re i za po sle ne.

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2.2. ALIMS OrganizationALIMS organization is adapted to the busi-ness processes and is a modern structure, of a functional type. Therefore, the regulatory jobs of medicines and medical devices regis-tration are organized at the Human Medicines Centre, Medical Devices Department and Veterinary Medicines Department and labo-ratory quality control at the National Control Laboratory (NCL). In ALIMS there is also the National Centre for Information on Medicines and Medical Devices (NCI) and the National Pharmacovigilance Centre (NPC) while the quality management activities for the whole ALIMS are organized and coordinated by the Quality Management Manager. Implementa-tion of regulatory affairs are monitored and supported by organizational units combined in the Centre for Support.

2.2. Or ga ni za ci ja ALIMSOr ga ni za ci ja ALIMS pri la go đe na je po slov-nim pro ce si ma i pred sta vlja mo der nu struk-tu ru, funk ci o nal nog ti pa. Sto ga su re gu la tor-ni po slo vi sta vlja nja u pro met le ko va i me-di cin skih sred sta va or ga ni zo va ni u Cen tru za hu ma ne le ko ve, Sek to ru za me di cin ska sred stva i ve te ri nar skom sek to ru a la bo-ra to rij ska kon tro la kva li te ta u Na ci o nal noj kon trol noj la bo ra to ri ji (NKL). U ALIMS-u još po sto je i Na ci o nal ni cen tar za in for ma ci je o le ko vi ma i me di cin skim sred stvi ma (NCI) i Na ci o nal ni cen tar za fa r ma ko vi gi lan cu (NCF), dok po slo ve upra vlja nja kva li te tom za či tav ALIMS or ga ni zu je i ko or di ni ra di-rek tor upra vlja nja kva li te tom. Re a li za ci ju re gu la tor nih po slo va pra te i po dr ža va ju or-ga ni za ci o ne ce li ne ob je di nje ne u Cen tar za po dr šku.

DirektorManaging director

Kancelarija direktoraManaging Director O�ce

Direktor upravljanja kvalitetomQM Manager

Nacionalna kontrolnalaboratorija

National ControlLaboratory

Nacionalni centar za informacijeo lekovima i medicinskim sredstvima

National Centre for Information on Medicines and Medical Devices

Fizičko-hemijskalaboratorijaPhysico-ChemicalLaboratory

Biološka laboratorijaBiological Laboratory

Odeljenje za upravljanjekvalitetom i podrškuQuali� Managment and Support Unit

Sektor za medicinska sredstva

Medical DevicesDepartment

Veterinarski sektorVeterinary Medicines

Department

Farmaceutski sektorPharmaceutical Department

Sektor za procenu dokumentacije o lekuAssessment Department

Sektor za stavljanje u promet humanih lekovaLicencing Department

Medicinski sektorMedical Department

Nacionalni centar za farmakovigilancuNational PharmacovigilanceCentre

Centar za humane lekove

Human Medicines Centre

Finansijski sektorFinancial Department

Odsek za računovodstvoAccounting Department

Odsek za komercijalneposloveDepartment of Commercial A�airs

Služba za prijem zahtevaiz nadležnosti Agencije iposlove pisarnice Receipt and IssuingA�airs

Odeljenje za prave i opšte posloveLegal and General A�airs

Grupa za informacionutehnologijuIT Group

Administrativni sektorAdministrative Department

Centar za podrškuCentre for Support

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Managing bodies of the Agency are a Man-aging Board and managing director. The Managing board has a chairman and four members, one of whom is chosen among the Agency employees.

Within the Agency also operate Commi-ssions, which are made by experts, collabo-rators of the Agency and these are:

•Committee for Marketing Authorization ofHuman Medicines

•Committee for Marketing Authorization ofVeterinary Medicines

•CommitteeforMedicalDevices• Committee for Human Medicines ClinicalTrials Assessment•Committee for Medicines Safety Assess-

ment•Committee for Veterinary Medicines Phar-

macovigilance•CommitteeforVeterinaryMedicinesClinical

Trials Assessment

In addition, in certain matters of expert evalu-ation ALIMS uses services of external experts, the most eminent experts in our country in certain areas of medicine and pharmacy. Fi-nally, ALIMS was the host of other bodies, such as the European Pharmacopoeia Com-mission (on the picture).

Upravni organi Agencije su Upravni odbor i direktor. Upravni odbor ima predsednika i četiri člana, od kojih se jedan bira iz reda zaposlenih u Agenciji.

U okvi ru Agen ci je ta ko đe funk ci o ni šu Ko mi-si je ko je či ne eks per ti, sa rad ni ci Agen ci je i to su:

•Komisija za stavljanje u promet humanihlekova

•Komisijazastavljanjeuprometveterinarskihlekova

•Komisijazamedicinskasredstva•Komisija za procenu kliničkih ispitivanja

humanih lekova•Komisijazaprocenubezbednostilekova•Komisijaza farmakovigilancuveterinarskih

lekova•Komisija za procenu kliničkih ispitivanja

veterinarskih lekova

Pored ovoga, ALIMS u pojedinim pitanjima stručne procene koristi i usluge spoljnih eksperata, najeminentnijih stručnjaka u našoj zemlji za pojedine oblasti medicine i farmacije. Konačno, ALIMS je bio i domaćin drugim telima kao što je Komisija Evropske farmakopeje (na slici).

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2.3. Background and entrusted activities Already in the 1948, within the federal admin-istrative body of Yugoslavia, responsible for health, a Federal Bureau was established, which in addition to medicines was dealing with testing and control of sera and vaccines, as well as cosmetics, dietary supplements, medical equipment, and other materials that are used in medical purposes. This Institute has grown into the Republic Institute for testing and control of medicines, which under the name of The Phar-macy Institute of Serbia operates from 1960.Serbia develops a new national policy on medi-cines in accordance with the amended system of production and distribution of medicines in the world, and the Law on Medicinal Products and Medical Devices (2004) is adopted, pursu-ant to which the manufacture and distribution of medicines and medical devices is harmo-nized with directives and recommendations of EU and ICH and on the basis of which in 2004 the Medicines and Medical Devices Agency of Serbia is formed. During its long history, generations of phar-macists, doctors, chemists, and other profes-sions, specialists, masters and PhD’s, as well as hundreds of employees have become part of the history and traditions of the Pharma-cy Institute and at the same time, Medicines and Medical Devices Agency of Serbia.

2.3. Isto ri jat i po ve re ni po slo viVeć 1948. godine, pri Sa ve znom or ga nu upra-ve Jugoslavije, za du že nom za po slo ve zdrav-stva, osno van je Sa ve zni za vod za ko ji se pored le ko va ba vio i is pi ti va njem i kon tro lom se ru ma i vak ci na, ali i ko zme ti ke, di je tet skih pro iz vo da, me di cin ske opre me, i svih dru-gih ma te ri ja la ko ji slu že u me di cin ske svr he. Ovaj Za vod je pre ra stao u re pu blič ki Za vod za is pi ti va nje i kon tro lu le ko va, ko ji pod ime-nom Za vod za fa r ma ci ju Sr bi je ra di od 1960. go di ne.Sr bi ja raz vi ja no vu na ci o nal nu po li ti ku u obla sti le ko va u skla du sa iz me nje nim si ste-mom pro iz vod nje i pro me ta le ko va u sve tu, usva ja se Za kon o le ko vi ma i me di cin skim sred stvi ma (2004.), u skla du sa ko ji ma se pro iz vod nja i pro met le ko va i me di cin skih sred sta va uskla đu je sa di rek ti va ma i pre po-ru ka ma EU i ICH i na osno vu ko ga se 2004. go di ne fo r mi ra Agen ci ja za le ko ve i me di cin-ska sred stva Sr bi je.To kom nje go ve du ge isto ri je, ge ne ra ci je di-plo mi ra nih fa r ma ce u ta, lekara, hemičara, i drugih profesija, specijalista, ma gi sta ra i dok-to ra na u ka, kao i sto ti ne za po sle nih, po sta li su deo isto ri je i tra di ci je Za vo da za farmaciju i ujed no, Agen ci je za le ko ve i me di cin ska sred-stva Sr bi je.

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The Medicines and Medical Devices Agency of Serbia is authorized to:

1. Issue marketing authorizations, decide on variations, renewals and transfer, as well as the termination of marketing authorizations;

2. Enter medical devices into the Register of Medical Devices, decide on the variations, registration renewals, as well as removal of medical devices from the Register of Medical Devices;

3. Perform registration in the Register of Tra-ditional Herbal Medicinal products, or reg-istration in the Register of Homeopathic Medicinal products;

4. Issue authorizations for clinical trials of medicinal products and medical devices conduct, decide on variations of the au-thorizations, and/or protocols on the con-duct of clinical trials, and make decisions regarding the application of clinical trials, and control the conduct of clinical trials;

5. Monitor adverse medicinal product reac-tions (pharmacovigilance), and adverse reactions to medical devices (vigilance of medical devices);

6. Issue certificates for the exports of medici-nal products and medical devices in accor-dance with the recommendations of the World Health Organization;

7. Authorize the imports of medicinal products and medical devices for a treatment of a particular patient or a group of patients, as well as medicinal products or medical de-vices for scientific and medical research;

8. Perform the classification of medicinal products or medical devices;

9. Authorize the advertising of medicinal products and medical devices;

10. Collect and process data on marketing and consumption of medicinal products and medical devices;

11. Provide information and suggestions for rational use of medicinal products and medical devices;

12. Integrate into the international networks of information on medicinal products and medical devices, as well as with the agen-cies responsible for medicinal products and medical devices, and their associations;

Agen ci ja za le ko ve i me di cin ska sred stva Sr bi je je nad le žna da:

1. Iz da je do zvo le za lek, od lu ču je o iz me ni i do pu ni, ob no vi i pre no su, kao i pre stan ku va že nja do zvo le za lek;

2. Vr ši upis me di cin skog sred stva u Re gi star me di cin skih sred sta va, od lu ču je o iz me ni i do pu ni, ob no vi upi sa, kao i bri sa nju me-di cin skog sred stva iz Re gi stra me di cin-skih sred sta va;

3. Vr ši upis u Re gi star tra di ci o nal nih bilj nih le ko va, od no sno upis u Re gi star ho me o-pat skih le ko va;

4. Iz da je do zvo le za spr o vo đe nje kli nič kog is pi ti va nja le ka i me di cin skog sred stva, od lu ču je o iz me ni i do pu ni do zvo le, od-no sno pro to ko la o spr o vo đe nju kli nič-kog is pi ti va nja le ko va, do no si od lu ke u ve zi s pri ja vom kli nič kog is pi ti va nja, vr ši kon tro lu spr o vo đe nja kli nič kog is-pi ti va nja;

5. Pra ti ne že lje ne re ak ci je na le ko ve (fa r ma-ko vi gi lan ca), kao i ne že lje ne re ak ci je na me di cin ska sred stva (vi gi lan ca me di cin-skih sred sta va);

6. Iz da je uve re nja za po tre be iz vo za le ko va i me di cin skih sred sta va u skla du s pre-po ru ka ma Svet ske zdrav stve ne or ga ni-za ci je;

7. Odo bra va uvoz le ko va i me di cin skih sred-sta va za le če nje od re đe nog pa ci jen ta ili gru pe pa ci je na ta, kao i le ko va ili me di cin-skih sred sta va za na uč na i me di cin ska is-tra ži va nja;

8. Vr ši ka te go ri za ci ju le ko va, od no sno me di-cin skih sred sta va;

9. Odo bra va ogla ša va nje le ko va i me di cin-skih sred sta va;

10. Vr ši pri ku plja nje i ob ra du po da ta ka o pro-me tu i po tro šnji le ko va i me di cin skih sred-sta va;

11. Da je in for ma ci je i pred lo ge za ra ci o nal no ko ri šće nje le ko va i me di cin skih sred sta va;

12. Po ve zu je se sa me đu na rod nim mre ža-ma in for ma ci ja o le ko vi ma i me di cin skim sred sta vi ma i sa agen ci ja ma nad le žnim za le ko ve i me di cin ska sred stva i nji ho vim aso ci ja ci ja ma;

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13. Participate in planning and implementa-tion of systematic control of medicines and medical devices, and random sam-pling from the market;

14. Provide opinions for the imports and ex-ports of cell or tissue samples for clinical trials procedures of medicinal products;

15. Perform the quality control of medicinal products and medical devices;

16. Prepare professional publications of the Agency;

17. Perform the other activities in accordance with the Law.

ALIMS actively participates in the develop-ment of the pharmaceutical sector in Serbia, making subordinate legislation, further elab-oration of the national policy in the area of medicines and medical devices, and interna-tional cooperation. Finally, it is important to emphasize that AL-IMS is also a teaching center for students of pharmaceutical and other universities in Ser-bia and that scientific research is conducted in this institution.

Facility capacitiesActivities in ALIMS are carried out in two objects – the old building, which belonged to the Pharmacy Institute of Serbia and the new facility the construction of which was financed from the project of the European Agency for Reconstruction. All the laboratories within the National Control Laboratory of the Agency have been renovated so as to comply with the strictest world demands in the domain of quality control, particularly the Microbiological Laboratory, i.e. its sterile block.

EquipmentThe Agency disposes with the latest equip-ment necessary for the quality control of medicines and medical devices, as well as for the informatics support for all processes conducted in the Agency. Necessary equip-ment qualification and calibration, as well as computer data protection processes are per-formed on a regular basis, according to the plans defined.

13. Uče stvu je u pla ni ra nju i spr o vo đe nju si-ste ma t ske kon tro le le ko va i me di cin skih sred sta va i uzi ma nju slu čaj nih uzo ra ka iz pro me ta;

14. Da je mi šlje nja za uvoz i iz voz uzo ra ka će-li ja, od no sno tki va za po stu pak kli nič kog is pi ti va nja le ko vi ma;

15. Vr ši kon tro lu kva li te ta le ko va i me di cin skih sred sta va;

16. Pri pre ma struč ne pu bli ka ci je iz nad le žno-sti Agen ci je;

17. Vr ši i dru ge po slo ve, u skla du sa za ko nom.

ALIMS аktivno uče stvu je u raz vo ju fa r ma ce-ut ske de lat no sti u Sr bi ji, iz ra di pod za kon skih pro pi sa, da ljoj do grad nji na ci o nal ne po li ti ke u obla sti le ko va i me di cin skih sred sta va i me-đu na rod noj sa rad nji. Na kra ju, va žno je is ta ći da je ALIMS i na stav-na ba za za stu den te Fa r ma ce ut skih i dru gih fa kul te ta u Sr bi ji i da se u ovoj in sti tu ci ji spr o-vo de i na uč na is tra ži va nja.

Pro stor ni re sur siAk tiv no sti u ALIMS od vi ja ju se u dva objek ta - sta roj zgra di, ko ja je pri pa da la Za vo du za far-ma ci ju Sr bi je i no vom objek tu, či ja je iz grad-nja fi nan si ra na iz pro jek ta Evr op ske agen ci je za re kon struk ci ju. Sve la bo ra to ri je u okvi ru Na ci o nal ne kon trol ne la bo ra to ri je ALIMS su re no vi ra ne ta ko da od go va ra ju naj stro ži jim svet skim zah te vi ma u obla sti kon tro le kva li-te ta, što se na ro či to od no si na Mi kro bi o lo šku la bo ra to ri ju, od no sno ste ril ni blo k ove la bo-ra to ri je.

Opre maALIMS ras po la že naj sa vre me ni jom opre-mom, neo p hod nom ka ko za kon tro lu kva li te-ta le ko va i me di cin skih sred sta va, ta ko i za in for ma tič ku po dr šku svim pro ce si ma ko ji se u ALIM SU oba vlja ju. Neo p hod ne kva li fi ka ci-je i ka li bra ci je opre me, kao i pro ce si za šti te po da ta ka na ra ču na ru se re dov no oba vlja ju, pre ma de fi ni sa nim pla no vi ma.

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2.4. Human ResourcesResponsible, complex and diverse activities of the Agency are performed by trained, qualified, professional and experienced staff. Agency, in its personnel policy tried, when it comes to the age structure of employees, to be representa-tive of all three age categories: the wisdom of experienced professionals, innovative youth power and strength of maturity.

Percentage composition of employees by education level

2.4. Ljud ski re sur siOd go vor nu, slo že nu i ra zno vr snu de lat nost Agen ci je za le ko ve i me di cin ska sred stva Sr-bi je oba vlja ško lo va no, kva li fi ko va no, struč no i is ku sno oso blje. Agen ci ja se, u svo joj ka drov-skoj po li ti ci tru di la, da ka da je u pi ta nju sta ro-sna struk tu ra ka dro va, bu du za stu plje ne sve tri sta ro sne ka te go ri je: mu drost is ku snih struč-nja ka, ino va tiv na mla dost i sna ga zre lo sti.

Pro cen tu al na struk tu ra za po sle nih pre ma struč noj spre mi

Visoka stručna spremaUniversity degree

71%

Srednja stručna spremaHigh school degree

25%

Viša stručna spremaCollege degree

4%

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2.5. International cooperation and membership in international organizationsInternational Cooperation of the Medicines and Medical Devices Agency of Serbia is built upon and is a branch of the health and pharmaceuti-cal sectors in Serbia cooperation with interna-tional and national regulatory bodies and insti-tutions that has been lasting over 60 years. Serbia at the end of the last century begins and especially in the new millennium has es-tablished intensive cooperation in the forma-tion of new system of medicines regulation harmonized with the EU and ICH regulations and recommendations. This was done main-ly through multilateral cooperation with EU institutions, the World Health Organization (WHO), the European Agency for Reconstruc-tion (EAR), the European Medicines Agency (EMA), European Directorate for the Quality of Medicines and Healthcare within the Council of Europe (EDQM), the European network of laboratories in charge of medicines control in the EDQM (OMCL Network), with organiza-tion Heads of Medicines Agencies (HMA), the World Organization for Animal Health (OIE) and many others and through direct bilateral cooperation with national agencies of the EU countries, as well as through regional coop-eration with countries of Southeast Europe. In the prospect of joining the EU, the construc-tion of a new regulatory framework and the establishment of the Agency was supported by several European Union projects in the pe-riod since 2002.Largest such project was the Twinning proj-ect entitled “Capacity Building of the Medi-cines and Medical Devices Agency of Serbia” since February 2007 until March 2009 with the French Agency for Health Products Safety (Agence Française de Securité Sanitare des Produits de Santé – ANSM (former AFSSAPS))

2.5. Me đu na rod na sa rad nja i član stvo u me đu na rod nim or ga ni za ci ja ma

Me đu na rod na sa rad nja Agen ci je za le ko ve i me di cin ska sred stva Sr bi je se na do ve zu je i pred sta vlja ogra nak sa rad nje zdrav stve nog i fa r ma ce ut skog sek to ra u Sr bi ji sa me đu na-rod nim i na ci o nal nim re gu la tor nim or ga ni ma i in sti tu ci ja ma ko ja tra je pre ko 60 go di na.Sr bi ja kra jem pret hod nog ve ka za po či nje i po seb no u no vom mi le ni ju mu ostva ru je in-ten ziv nu sa rad nju na fo r mi ra nju no vog si-ste ma re gu li sa nja le ko va ha r mo ni zo va nog sa EU i ICH pro pi si ma i pre po ru ka ma. To je urađeno uglav nom kroz mul ti la te ral nu sa-rad nju sa in sti tu ci ja ma EU, Svet ske zdrav-stve ne or ga ni za ci je (SZO), Evr o p skom agen-ci jom za re kon struk ci ju (EAR), Evr o p skom agen ci jom za le ko ve (EMA), Evr op skim di rek-to ra tom za kva li tet le ko va i bri gu o zdra vlju u okvi ru Sa ve ta Evr o pe (EDQM), Evr op skom mre žom la bo ra to ri ja nad le žnih za kon tro lu le ko va u okvi ru EDQM (OMCL Net work), sa organizacijom Rukovodioci agencija za lekove (HMA), Svetskom organizacijom za zdravlje životinja (OIE) i mnogim drugim, a i pu tem di-rekt ne bi la te lar ne sa rad nje sa na ci o nal nim autoritetima ze ma lja EU i sveta, kao i kroz re-gi o nal nu sa rad nju sa ze mlja ma ju go i stoč ne Evr o pe.U pe r spek ti vi pri dru ži va nja EU, iz grad nja no-vog re gu la tor nog okvi ra i osni va nje Agencije je po dr ža no od stra ne ne ko li ko pro je ka ta Evr op ske uni je u pe ri o du od 2002. go di ne. Naj ve ći ta kav pro je kat je bio Tvining pro je kat pod ime nom „Iz grad nja ka pa ci te ta Agen ci je za le ko ve i me di cin ska sred stva Sr bi je“ od fe-bru a ra 2007. do ma r ta 2009. go di ne sa Fran-cu skom agen ci jom za bez bed nost zdrav stve-nih pro iz vo da (Agen ce Française de Se cu rité Sa ni ta re des Pro du its de Santé - ANSM, ranije AFSSAPS) i Francuskom Agen ci jom za ve te ri-

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and the French Agency for veterinary medi-cines (Agence Française de Sécurité Sanitaire des Alments - ANSES - ANMV).In the framework of international cooperation that the Agency is currently running, we should first point out activities under the IPA project (The Instrument of Pre-Accession Assistance), which is realized in the period since 2009. It is cooperation with the European Medicines Agency (EMA) within Serbia’s EU accession.

Another important project implemented by the Agency during the period from May 2011 until June 2012 is “Building the capacity of the Agency for Medicines and Medical Devices of Montenegro (CALIMS).” This project was funded by the World Bank, and involves im-proving the competence and work process in CALIMS through mission of our experts in the

nar ske le ko ve (Agen ce Française de Se cu rité Sa ni ta i re des Al ments – ANSES - ANMV).U okvi ru me đu na rod ne sa rad nje ko ju Agen-ci ja tre nut no vo di, naj pre tre ba is ta ći ak tiv-no sti u okvi ru IPA pro jek ta (The In stru ment of Pre ac ces sion As si stan ce) ko ji se re a li zu je u pe ri o du od 2009. go di ne. U pi ta nju je sa-rad nja sa Evr op skom agen ci jom za le ko ve (EMA) u okvi ru pri dru ži va nja Sr bi je Evr op-skoj uni ji.

Još je dan va žan pro je kat ko ji je Agen ci ja re a-li zo va la u pe ri o du od ma ja 2011. do ju na 2012. go di ne je „Iz grad nja ka pa ci te ta Agen ci je za le ko ve i me di cin ska sred stva Cr ne Go re (CA-LIMS)“. Ovaj pro je kat je fi nan si ran od stra ne Svet ske ban ke, a pod ra zu me vo je una pre đe-nje kom pe tent no sti i pro ce sa ra da u CALIMS-u kroz mi si je na ših eks pe ra ta u Pod go ri ci i stu-

Agence Nationale du Médicament Vétérinaire (ANMV)

C ALIMSAgencija za lijekove

i medicinska sredstva Crne GoreAgency for Medicines and

Medical Devices of Montenegro

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in Podgorica and study visits of CALIMS ex-perts to Belgrade. It is important to point out the contracts for professional and technical cooperation with agencies of the countries in the region (Bosnia and Herzegovina, Montenegro) for which the Agency, among other things performs quality control for certain products, and the other con-tracts, such as those with both of these agen-cies of France (ANSM and ANMV), continuing the cooperation with these institutions after successfully completing the Twinning project and the latest agreements with the national authorities of Italy - Italian Medicines Agency (Agenzia Italiana del Pharmaco - AIFA) and Canada - Health Canada.In addition, as part of an intensive cooperation with the European Directorate for the Qual-ity of Medicines and Health Care (EDQM) in Strasbourg, France, ALIMS has a represen-tative in the European Pharmacopoeia Com-mission within the EDQM. This includes par-

dij ske bo rav ke eks pe ra ta CALIMS-a u Be o-gra du.Va žno je is ta ći i ugo vo re o struč no-teh nič-koj sa rad nji sa agen ci ja ma ze ma lja u re gi-o nu (Bo sna i He r ce go vi na, Cr na Go ra) za ko je Agen ci ja, iz me đu osta log ra di kon tro lu kva li te ta od re đe nih pre pa ra ta, ali i dru ge ugo vo re, kao one sa obe po me nu te Fran cu-ske agen ci je (ANSM i АNMV), što pred sta-vlja na sta vak sa rad nje za ovim in sti tu ci ja-ma po sle uspe šno okon ča nog Tvining pro-jek ta i najnovije sporazume sa nacionalnim autoritetima Italije - Agencija za lekove Italije (Agenzia Italiana del Pharmaco - AIFA) i Kanade – Ministarstvo zdravlja Kanade.Po red ovo ga, u okvi ru in ten ziv nu sa rad nje sa Evr op skim di rek to ra tom za kva li tet le-ko va i bri gu o zdra vlju (EDQM) u Stra zbu-ru, Fran cu ska, Agencija ima pred stav ni ka u ko mi si ji Evr op ske fa r ma ko pe je u okvi ru EDQM. Ovo pod ra zu me va uče šće u raz vo-

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Agencija za lekovei medicinska sredstva Srbije

Medicines and Medical DevicesAgency of Serbia

C ALIMSAgencija za lijekove

i medicinska sredstva Crne GoreAgency for Medicines and

Medical Devices of Montenegro

МИНИСТЕРСТВО ЗА ЗДРАВСТВОНА РЕПУБЛИКА МАКЕДОНИЈА

БИРО ЗА ЛЕКОВИ

ticipation in the development and revision of monographs of the European Pharmacopoe-ia, which provide standards for the quality of ingredients that are used in the pharmaceuti-cal industry. In the other bodies of EDQM AL-IMS through the participation of its experts also carries out international cooperation in the areas of serums and vaccines, and fight against counterfeit medicines, as well as evalutation of CEP and sterility.

ju i re vi zi ji mo no gra fi ja Evr op ske fa r ma ko-pe je ko je pred sta vlja ju stan dar de kva li te ta za sup stan ce ko je se ko ri ste u fa r ma ce ut-skoj in du stri ji. U okvi ru dru gih te la EDQM Agencija kroz uče šće svo jih eks pe ra ta ta-ko đe ostva ru je me đu na rod nu sa rad nju u obla sti ma se ru ma i vak ci na i bo r be pro tiv fal si fi ko va nih le ko va, kao i evaluaciju CEP-a i sterilnosti.

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Agencija za lekovei medicinska sredstva Srbije

Medicines and Medical DevicesAgency of Serbia

C ALIMSAgencija za lijekove

i medicinska sredstva Crne GoreAgency for Medicines and

Medical Devices of Montenegro

МИНИСТЕРСТВО ЗА ЗДРАВСТВОНА РЕПУБЛИКА МАКЕДОНИЈА

БИРО ЗА ЛЕКОВИ

Nacionalna kontrolna laboratorija (NKL) je član Evropske mreže zvaničnih kontrolnih laboratorija (OMCL mreža) a dugogodišnji izuzetni rezultati studija u kojima NKL učestvuje u OMCL mreži potvrđuju kvalitet rada i stručnost zaposlenih u ALIMS. Najnoviji sporazum koji je Agencija potpisala u junu 2014. godine je Memorandum o razumevanju i saradnji između regulatornih tela Srbije, Hrvatske, Bosne i Hercegovine, Makedonije i Crne Gore.

National Control Laboratory (NCL) is a mem-ber of the European Official Medicines Con-trol Laboratories Network (OMCL Network) and long-time exceptional results of studies in which NKL participates in OMCL network confirm the quality of the work and expertise of employees in ALIMS.The latest agreement the Agency has signed in June 2014 is a Memorandum of understand-ing and cooperation between regulatory bod-ies of Serbia, Croatia, Bosnia and Herzegovi-na, Macedonia and Montenegro.

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2.6. Development GoalsMedicines and Medical Devices Agency of Serbia, as the national competent authority for medicines, will ensure that in future, as-sessment procedure of quality, effectiveness and safety of medicines and registration in the Register of medical devices, meet the highest standards to the regulatory authori-ties in Europe so we can achieve the primary goal of the Agency - to ensure that all nec-essary medications and medical devices are available to patients in Serbia, in order to im-prove public health. Starting from the positive results achieved in the regulatory performance, as well as activi-ties that began in previous years, and in ac-cordance with applicable professional stan-dards in the performance of the agencies in the developed countries in the EU, the Agency has defined the following objectives:

• Continuationofestablishedgoodpracticein the implementation of regulatory activi-ties by detailed planning of priorities;

• Achievinggreaterqualityandefficiencyinthe execution of delegated activities, par-ticularly in relation to the issuance of au-thorizations for the entry of medicine and medical devices in the Register;

• Providing high quality documentation inthe evaluation of medicines in the licens-ing procedure (assessment of the quality, preclinical toxicity and clinical safety and efficacy, therapeutic equivalence and post-marketing medicine safety), in accordance with regulatory, technical and scientific guidelines of the European Union and oth-er accepted standards in this area;

• Quality control of medicines and medicaldevices in accordance with the standards of the European and national pharmacopoe-ia and other recognized standards in this area;

• Activitiesonaccreditationof theNationalControl Laboratory (NCL) in accordance to the demands of the SRPS ISO / IEC 17025:2006 standard;

2.6. Ci lje vi raz vo ja Agen ci ja za le ko ve i me di cin ska sred stva Sr bi je, kao na ci o nal ni kom pe tent ni auto ri tet za le ko ve, osi gu ra će da i u na red nom pe ri o-du po stu pak pro ce ne kva li te ta, efi ka sno sti i bez bed no sti le ko va i upis u Re gi star me di-cin skih sred sta va, bu de u funk ci ji ostva re nja pri mar nog ci lja Agen ci je – osi gu ra va nje da su pa ci jen ti ma u Sr bi ji do stup ni svi po treb ni le ko vi i me di cin ska sred stva, u ci lju una pre-đe nja jav nog zdra vlja, po što va njem naj vi ših stan dar da u ra du re gu la tor nih auto ri te ta u Evr o pi.Po la ze ći od već ostva re nih po zi tiv nih re zul-ta ta u re gu la tor noj pe r for man si, kao i od ak-tiv no sti ko je su za po če te u pret hod nim go di-nama, a u skla du sa va že ćim stan dar di ma u pro fe si o nal noj pe r for man si raz vi je nih agen-ci ja u ze mlja ma EU, Agen ci ja je de fi ni sa la sle de će ci lje ve:

• nastavak ustanovljene pozitivne prakse ure a li za ci ji re gu la tor nih ak tiv no sti de talj nim pla ni ra njem pri o ri te ta;

• ostvarivanjekvalitetaivećeefikasnostiuiz­vr ša va nju svih po ve re nih po slo va, a na ro či-to u od no su na po stu pak iz da va nja do zvo la za za lek i upi sa me di cin skih sred sta va u Re gi star;

• ostvarenjekvalitetaupostupkuevaluacijedo ku men ta ci je o le ko vi ma u okvi ru pro ce-du re iz da va nja do zvo la (pro ce na kva li te ta, pret kli nič ke tok sič no sti, kli nič ke efi ka sno sti i bez bed no sti, od no sno te ra pij ske ekvi va-lent no sti i post mar ke tin ške bez bed no sti le ko va), u skla du sa re gu la tor nim, struč-nim i na uč nim uput stvi ma Evr op ske uni je i dru gim pri hva će nim stan dar di ma u ovoj obla sti;

• kontrola kvaliteta lekova i medicinskihsred sta va u skla du sa stan dar di ma evr op-ske i na ci o nal ne fa r ma ko pe je i dru gim pri-hva će nim stan dar di ma u ovoj obla sti;

• aktivnosti na akreditaciji Nacionalnekon trol ne la bo ra to ri je (NKL) u skla du sa zahte vi ma stan dar da SRPS ISO/IEC 17025:2006;

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• Application of standards of Good ClinicalPractice, approval in Serbia of only those clin-ical trials, which are in accordance with the principles of Good Clinical Practice, as well as greater control of their implementation;

• Improvementofthenationalpharmacovig-ilance system of human and veterinary medicines;

• Development of system of vigilance formedical devices and establishing and de-volping a system of vigilance for vacci nes and herbal medicines;

• Further development of the regular provi-sion of information on medicines and medi-cal devices to healthcare professionals and the general public;

• Thepromotionofinternationalcooperationand networking with other agencies and international associations;

• Strengthening human resource capacity ofthe Agency by increasing the total number of employees, and strengthening the compe-tence of experts on the expert work of docu-mentation through continuous education;

• Improvement in spatial capacities of theagency, in terms of providing basic work-ing conditions;

• Combatingcounterfeitmedicinesandmedi­cal devices;

• Furtheractivitiesinthefieldofeducationofpublic and healthcare professionals.

• primenastandardaDobrekliničkeprakse,odo bre nje onih kli nič kih is pi ti va nja u Sr bi ji, ko ja su u skla du sa prin ci pi ma Do bre kli-nič ke prak se, kao i ja ča kon tro la nji ho vog spr o vo đe nja;

• unapređenje nacionalnog sistema far­ma ko vi gi lan ce hu ma nih i ve te ri nar skih le ko va;

• razvojsistemavigilancemedicinskihsred­sta va i us po sta vlja nje i razvoj sistema vigilance vak ci na i bilj nih le ko va;

• daljirazvojsistemaredovnogpružanjain­for ma ci ja o le ko vi ma i me di cin skim sred-stvi ma struč noj i op štoj jav no sti;

• unapređenjemeđunarodnesaradnje i po­ve zi va nje sa dru gim agen ci ja ma i me đu na-rod nim aso ci ja ci ja ma;

• jačanjekadrovskihkapacitetaAgencijepo­ve ća va njem ukup nog bro ja za po sle nih, kao i ja ča njem kom pe tent no sti struč nja ka na eks pert skim po slo vi ma pro ce ne do ku men-ta ci je kon ti nu i ra nom edu ka ci jom;

• unapređenjeprostornihkapacitetaAgenci­je, u smi slu obez be đe nja osnov nih uslo va ra da;

• borbaprotivfalsifikovanihlekovaimedicin­skih sred sta va;

• daljeaktivnostinapoljuedukacijejavnostii zdravstvenih rad ni ka.

3. Re gu la tor na pe r for man sa ALIMS

3. ALIMS Regulatory performance

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3.1. Pre-registration activitiesIn order to provide better conditions for the prevention, diagnosis, treatment and rehabil-itation to the population of Serbia and health care workers in health services, it is necessary that on the Serbian market a broad a range of high quality, safe and effective medicines and medical devices is represented, which is an obligation of ALIMS. In assessing the pharmaceutical, pharmaco-logical-toxicological and clinical documenta-tion on quality, safety and efficacy of medicine ALIMS experts, and ALIMS associate experts are involved. Assessment of documentation is done in accordance with the Law on Medi-cines and Medical Devices, and based on the entire General Technical Document (Common Technical Dossier - CTD) or the European re-cord, which is submitted by the client when applying. First expert assessment of the documenta-tion for medicine is made in Licencing De-partment for Human Medicines as part of the formal evaluation of the documentation. This type of assessment relates to whether the request for registration / renewal meets all requirements in terms of completeness and validity of documents provided by the Law and bylaws. When the documentation meets requirements of formal assessments, each part of it (quality, safety, efficiency), is given a detailed and professional estimate within the essential assessment.After finishing the essential assessment, the preparation and organization of the Commis-sion for Marketing Authorization and MA re-newal of the human medicines is performed in Licencing Department. Committee is consti-tuted of eminent experts from various fields of medicine and pharmacy, which on the ba-sis of the assessment report on the medici-nal product documentation expert services of our Agency, and their knowledge and experi-ence give an opinion whether the medicines should be licensed for marketing.

3.1. Pred re gi stra ci o ne ak tiv no stiKa ko bi se sta nov ni štvu Sr bi je i zdrav stve nim rad ni ci ma pri pru ža nju zdrav stve nih uslu ga omo gu ći li što bo lji uslo vi za pre ven ci ju, di jag-no sti ku, le če nje i re ha bi li ta ci ju, po treb no je da na tr ži štu Sr bi je bu de za stu pljen što ši ri asor ti man kva li tet nih, bez bed nih i efi ka snih le ko va i me di cin skih sred sta va, što je oba ve-za ALIMS.U pro ce ni fa r ma ce ut ske, fa r ma ko lo ško-tok-si ko lo ške i kli nič ke do ku men ta ci je o kva li te-tu, bez bed no sti i efi ka sno sti le ka uče stvu-ju eks per ti ALIMS, kao i eks per ti sa rad ni ci ALIMS. Pro ce na do ku men ta ci je se oba vlja u skla du sa Za ko nom o le ko vi ma i me di cin-skim sred stvi ma, a na osno vu uvi da u kom-ple tan Op šti teh nič ki do cu ment (Com mon Tec hni cal Dos si er – CTD) ili Evr op ski do si-je, ko ji kli jent do sta vlja pri li kom pod no še-nja zah te va.Pr va struč na pro ce na do ku men ta ci je za lek se vr ši u Sek to ru za sta vlja nje u pro met hu-ma nih le ko va u okvi ru fo r mal ne pro ce ne do-ku men ta ci je. Ova vr sta pro ce ne od no si se na to da li pod net zah tev za re gi stra ci ju/ob no vu is pu nja va sve uslo ve u po gle du kom plet no-sti i va lid no sti do ku men ta ci je pro pi sa ne Za-ko nom i pod za kon skim ak ti ma. Ka da do ku-men ta ci ja is pu ni uslo ve fo r mal ne pro ce ne, sva ki njen deo (kva li tet, bez bed nost, efi ka-snost), se da lje de talj no i struč no pro ce nju je u okvi ru su štin ske pro ce ne.Na kon za vr še ne su štin ska pro ce ne, u ovom sektoru vr ši se pri pre ma i or ga ni zo va nje Ko-mi si je za iz da va nje i ob no vu do zvo le za sta-vlja nje hu ma nih le ko va u pro met. Ko mi si ju či ne emi nent ni struč nja ci iz raz li či tih obla sti me di ci ne i fa r ma ci je ko ji na osno vu iz ve sta ja pro ce ne do ku men ta ci je o le ku struč nih slu-žbi ALIMS, i svog zna nja i is ku stva da ju mi-šlje nje da li lek tre ba da do bi je do zvo lu za sta vlja nje u pro met.

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If the medicine is approved for the marketing authorization, in Licencing Department the formation, control and approval of the Agen-cy’s final output document is made: Market-ing Authorization and its components - Sum-mary of product characteristics (SmPC), Pa-tient information leaflet (PIL) and the text for the outer and inner packaging of medicine.Summary of product characteristics is intended for health professionals (doctors and pharma-cists) and provides all the information neces-sary for the proper prescribing and use of medi-cines. It represents a brief dossier of medicine, and information presented herein is based in the assessment of medicine documents and information harmonization with those currently approved in the European Union.Patient information leaflet is intended for the patient and allows him to understand all as-pects of therapy with appropriate medicine. The leaflet must be consistent with the sum-mary of product characteristics, written in a

Uko li ko je lek odo bren za iz da va nje do zvo-le, u Sek to ru za sta vlja nje u pro met hu ma nih le ko va se vr ši fo r mi ra nje, kon tro la i odo bra-va nje fi nal nih iz la znih do ku men ta Agen ci je: Re še nja za sta vlja nje le ka u pro met i nje go-vih sa stav nih de lo va - Sa že tka ka rak te ri sti ka le ka (SmPC), Uput stva za lek (PIL) i teksta za spolj nje i unu tra šnje pa ko va nje le ka.Sa že tak ka rak te ri sti ka le ka je na me njen zdrav stve nim struč nja ci ma (le ka ri ma i fa r ma-ce u ti ma) i pru ža sve in for ma ci je neo p hod ne za pra vil no pro pi si va nje i upo tre bu le ka. On pred sta vlja kra tak do si je le ka, a in for ma ci je iz ne te u nje mu su ute me lje ne u pro ce ni do ku-men ta ci je le ka i ha r mo ni za ci ji in for ma ci ja sa onim ak tu el nim, odo bre nim u Evr op skoj uni ji.Uput stvo za lek na me nje no je pa ci jen tu i omo gu ća va mu da raz u me sve aspek te te ra-pi je od go va ra ju ćim le kom. Uput stvo mo ra bi-ti u skla du sa sa žet kom ka rak te ri sti ka le ka, na pi sa no na na čin ra zu mljiv pa ci jen tu, ja sno i krat kim re če ni ca ma. Na la zi se u pa ko va nju

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manner understandable to the patients, with clear and short sentences. It is located in the package of the medicine. The primary role of the text package is clear and unambiguous identification of the medicine and the condi-tions for its safe use. Through defining and entering the master data on the medicine into the central data-base of the Agency in the Agency’s informa-tion system the life cycle of a medicine can be tracked, or any changes in its quality, safety and efficacy. Also, it allows that output data to the Agency’s documents are accurate and precise, as well as links similar medicines, and thus identifying the therapeutic parallels. Agency, based on the estimated documenta-tion allows the importation of unregistered medicines and medical devices necessary for the immediate, specific treatment of individual patients or groups of patients, at the request of health care institutions. Also, the importation of medicines and medical devices intended for clinical and scientific research as well as in the purpose of obtaining a marketing authorization is allowed.Assessment of medicine safety includes eval-uation of documentation on product safety in the process of obtaining a license for its mar-

le ka. Pri mar na ulo ga tek sta pa ko va nja je ja-sna i ne dvo smi sle na iden ti fi ka ci ja le ka i uslo-va za nje go vu bez bed nu pri me nu.Kroz de fi ni sa nje i unos ma tič nih po da ta ka o le ku u cen tral nu ba zu po da ta ka Agen ci je se u in for ma ci o nom si ste mu Agen ci je mo že pra-ti ti ži vot ni ci klus le ka, od no sno sve pro me ne u okvi ru njegovog kva li te ta, bez bed no sti i efi-ka sno sti. Ta ko đe, to omo gu ća va da po da ci na iz la znim do ku men ti ma Agen ci je bu du pre ci-zni i tač ni, kao i da se po ve žu slič ni le ko vi i na taj na čin iden ti fi ku ju te ra pij ske pa ra le le. Agen ci ja na osno vu pro ce nje ne do ku men ta-ci je odo bra va uvoz ne re gi stro va nih le ko va i me di cin skih sred sta va neo p hod nih za hit-nu, spe ci fič nu te ra pi ju po je di nih pa ci je na ta ili gru pe pa ci je na ta, na zah tev zdrav stve nih usta no va. Ta ko đe se odo bra va uvoz le ko va i me di cin skih sred sta va na me nje nih za kli nič-ka i na uč na is tra ži va nja kao i u svr hu do bi ja-nja do zvo le za sta vlja nje u pro met.Pro ce na bez bed no sti le ka pod ra zu me va eva-lu a ci ju do ku men ta ci je o bez bed no sti le ka u po stup ku do bi ja nja do zvo le za nje go vo sta-vlja nje u pro met, nje nih ob no va, iz me na i do-pu na (va ri ja ci je) i iz ra du eks pert skog iz ve šta-ja o bez bed no sti le ka, kao i pro ce na pe ri o dič-nog iz ve šta ja o bez bed no sti le ka (PSUR) do-

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keting, its renewal, amendment (variation) and the preparation of expert reports about medicine safety, as well as the assessment of periodic safety update reports (PSURs) submitted by the pharmaceutical industry af-ter obtaining a marketing authorization. As for the assessment of medicine efficacy, the documentation of efficacy is evaluated in the process of obtaining a license for its mar-keting, its renewal, amendment (variation) and the preparation of expert reports of medicine efficacy, and then assessment of bioequiva-lence documentation in the process of obtain-ing license for its marketing and development of an expert report on bioequivalence. In the Administrative Department, which is composed of the Office for receipt of applica-tions under the Agency’s competence and clerk’s office (administrative office) and Gen-eral and Legal Affairs Department where in addition to general legal activities, regulatory affairs are conducted. The employees in these positions are issuing legal opinions in the area of medicines and medical devices, as well as legal opinions in the process of formal evalua-tion of the documentation on the medicine. In addition to the Law on Medicines and Medical Devices Regulatory Affairs within the Agency the Law on Administrative Procedure in respect of all assigned duties is applied. Agency approves issue of control stamps, and printing of additional stamps for medicines on the packaging, as an additional identifica-tion and protection against counterfeiting. Agency acts on requests for access to infor-mation of public importance held by this pub-lic authority, which occurred in the workplace or in relation to its work. Applying these rules, in addition to dealing with medicines the Agency is responsible for ensuring that a free democratic order is estab-lished and informs the public about its work.

sta vlje nih od stra ne fa r ma ce ut ske in du stri je na kon do bi ja nja do zvo le za sta vlja nje le ka u pro met.Što se ti če pro ce ne efi ka sno sti le ka, vr ši se pro ce na do ku men ta ci je o efi ka sno sti le ka u po stup ku do bi ja nja do zvo le za nje go vo sta-vlja nje u pro met, nje nih ob no va, iz me na i do pu na (va ri ja ci je) i iz ra du eks pert skog iz-ve šta ja o efi ka sno sti le ka, a za tim pro ce na do ku men ta ci je o bi o e kvi va len ci ji u po stup ku do bi ja nja do zvo le za nje go vo sta vlja nje u pro-met i iz ra du eks pert skog iz ve šta ja o bi o e kvi-va len ci ji.U okvi ru Ad mi ni stra tiv nog sek to ra ko ji u svom sa sta vu ima Slu žbu za pri jem zah te va iz nad-le žno sti Agen ci je i po slo ve pi sar ni ce i Ode-lje nje za prav ne i op šte po slo ve po red op štih prav nih po slo va, oba vlja ju se i re gu la tor ni po-slo vi. Na i me, iz vr ši o ci na ovim rad nim me sti-ma iz da ju prav na mi šlje nja u obla sti le ko va i me di cin skih sred sta va, kao i prav na mi šlje nja u po stup ku fo r mal ne pro ce ne do ku men ta ci je o le ku. Po red Za ko na o le ko vi ma i me di cin skim sred-stvi ma, u okvi ru re gu la tor nih po slo va u Agen-ci ji se pri me nju je i Za kon o op štem uprav nom po stup ku u od no su na sve po ve re ne po slo ve.Agen ci ja odo bra va iz da va nje kon trol nih ma-r ki ca, kao i štam pa nje do dat nih ma r ki ca za le ko ve na stra nom pa ko va nju, kao dodatnu identifikaciju i zaštitu od falsifikovanja.Agen ci ja po stu pa i po zah te vi ma za slo bo dan pri stup in for ma ci ja ma od jav nog zna ča ja ko-ji ma ras po la že ovaj or gan jav ne vla sti, a ko je su na sta le u ra du ili u ve zi sa nje nim ra dom.Pri me nju ju ći na ve de ne pro pi se, po red bri ge o le ko vi ma i medicinskim sredstvima, Agen ci ja se sta ra da se ostva ri slo bod ni de mo krat ski po re dak i in for mi še jav nost o svom ra du.

0123456789

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3.2. Medical devicesMedical Devices Department performs the following entrusted tasks in the field of medical devices:• Entryofmedicaldevice in theRegisterof

medical devices;• Renewal, amendment of, and addition to

registration of medical devices in the Reg-ister of medical as a condition for release on the market of Serbia;

• Issuingexpertopinionsonthecategoriza-tion and classification of medical devices;

• Participate in the issuance of permits toimport unregistered medical devices, at the request of health institutions and the patients whose life is in danger;

• Participates in granting approval for theuse of promotional materials and other documentation relating to the advertising of medical devices;

• Monitoringofadversereactionstomedicaldevices (medical devices vigilance)

• Participationinthepreparationoflawsper-taining to the production and sale of medi-cal devices, etc.

For medical devices which have the CE mark, which means that the control of the medical devices was made in any of the accredited European notification bodies and that it is a medical device that complies with EU direc-tives on medical devices, registration of med-ical devices is an administrative procedure. However, for medical devices that do not have the CE mark, the procedure for registration of medical devices is significantly longer and more complicated, because it is done on the basis of a marketing authorization, and on the basis of the evaluation of quality, safety and efficacy, according to internationally ac-cepted standards.One of the important tasks for the Medical de-vices Department in the coming period is to establish a system of vigilance of medical de-vices in the country, with the aim of providing better protection and improvement of human life and health. Vigilance of medical devices is

3.2. Me di cin ska sred stvaSek tor za me di cin ska sred stva oba vlja sle de-će Za ko nom po ve re ne po slo ve iz obla sti me-di cin skih sred sta va: • upismedicinskogsredstavauRegistarme­

di cin skih sred sta va; • obnovu,izmenuidopunuupisamedicinskog

sred sta va u Re gi star me di cin skih sred sta va, kao uslov za pu šta nje u pro met na tr ži šte Sr bi je;

• izdavanjestručnihmišljenjaokategoriza­ci ji i kla si fi ka ci ji me di cin skih sred sta va;

• učestvuje u izdavanju odobrenja za uvozne re gi stro va nih me di cin skih sred sta va, na zah tev zdrav stve nih usta no va, a za ži vot no ugr o že ne pa ci jen te;

• učestvuje u izdavanju odobrenja za upo­tre bu pro mo tiv nog ma te ri ja la i dru ge do ku-men ta ci je ko ja se od no si na ogla ša va nje me di cin skog sred stva;

• vrši praćenje neželjenih reakcija na me­di cin ska sred stva (vi gi lan ca me di cin skih sred sta va);

• učestvuje u pripremi podzakonskih akataiz obla sti pro iz vod nje i pro me ta me di cin-skih sred sta va i dr.

Za me di cin ska sred stva ko ja po se du ju CE znak, a što pod ra zu me va da je kon tro la tog me di cin-skog sred stva iz vr še na u ne kom od akre di to va-nih evr op skih no ti fi ka ci o nih te la i da je to me di-cin sko sred stvo usa gla še no sa EU di rek ti va ma o me di cin skim sred stvi ma, upis u Re gi star me-di cin skih sred sta va je ad mi ni stra tiv na pro ce-du ra. Me đu tim, za me di cin ska sred stva ko ja ne po se du ju CE znak, pro ce du ra upi sa u Re gi-star me di cin skih sred sta va je zna čaj no du ža i ko mli ko va ni ja, jer se vr ši na osno vu do zvo le za sta vlja nje u pro met, a na ba zi ura đe ne pro ce ne kva li te ta, bez bed no sti i efi ka sno sti, pre ma me-đu na rod no pri hva će nim stan dar di ma.Je dan od va žnih za da ta ka Sek to ra za me di cin-ska sred stva u na red nom pe ri o du je us po sta-vlja nje si ste ma vi gi lan ce me di cin skih sred-sta va u na šoj ze mlji, a sve u ci lju obez be đe nja bo lje za šti te i una pre đe nja ži vo ta i zdra vlja lju di. Vi gi lan ca me di cin skih sred sta va je skup ak tiv no sti ko je se od no se na pri ku plja nje, pro-

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a set of activities related to the collection, as-sessment, understanding and responding to new information about the risks arising from the use or application of medical devices, and in particular its harmful effects, interactions with other substances or products, contrain-dications, abuse, reduced activity, failure and technically invalidity. The Agency organizes and monitors the vigilance of medical devices, collects information on the quality, safety and efficacy of medical devices after they are placed on the market, as well as the rate of discovery of known and new adverse reactions.On all matters within the jurisdiction of the Medical Devices Department, the cooperation with manufacturers of medical devices or their authorized representatives (representative of-fices, agents, distributors, etc.) is achieved.Significant acceleration and simplification of procedures for resolving clients requests within the jurisdiction of the Medical Devices Department, is of great importance and ben-eficial for both the customers and for patients and other users of medical devices, which will promptly and adequately have available high quality, safe and effective medical devices in the Serbian market.

Medical Devices Vigilance results

ce nu, raz u me va nje i re a go va nje na no va sa-zna nja o ri zi ci ma ko ji pro iz i la ze iz upo tre be ili pri me ne me di cin skog sred stva, a po seb no nje-go vog štet nog de lo va nja, in ter ak ci je s dru gim sup stan ca ma ili pro iz vo di ma, kon tra in di ka ci-je, zlo u po tre be, sma nje nog de lo va nja, kva ra i teh nič ke ne is prav no sti. Agen ci ja or ga ni zu je i pra ti vi gi lan cu me di cin skih sred sta va, pri ku-plja njem in for ma ci ja o kva li te tu, bez bed no sti i efi ka sno sti me di cin skih sred sta va po sle nji ho-vog pu šta nja u pro met, kao i uče sta lost po zna-tih i ot kri va nje no vih ne že lje nih re ak ci ja.Na svim po slo vi ma iz nad le žno sti Sek to ra za me di cin ska sred stva, ostva ru je se sa rad nja sa pro iz vo đa či ma me di cin skih sred sta va, od-no sno nji ho vim ovla šće nim pred stav ni ci ma (pred stav ni štvi ma, za stup ni ci ma, di stri bu te-ri ma i dr.). Zna čaj no ubr za nje i po jed no sta vlje na pro ce-du ra re ša va nja zah te va kli je na ta iz nad le-žno sti Sek to ra za me di cin ska sred stva, je od ve li kog zna ča ja i ko ri sti ka ko za sa me kli jen-te, ta ko i za pa ci jen te i dru ge ko ri sni ke me di-cin skih sred sta va, ko ji će bla go vre me no i na ade kva tan na čin ima ti do stup na kva li tet na, bez bed na i efi ka sna me di cin ska sred stva na tr ži štu Sr bi je.

Rezultati vigilance medicinskih sredstava

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3.3. Veterinary medicinesWithin the Agency exists a Veterinary Medi-cines Department is organized which is respon-sible for the marketing of veterinary medicines, renewal and variation, then also for clinical tri-als, pharmacovigilance of veterinary medicines and expert opinions while laboratory quality control of veterinary medicines is performed in the National Control Laboratory of the Agency. The prescribed structure of registration dossiers for veterinary medicine is divided into two sec-tions according to the type of medicines: phar-maceutical and immunological medicines. The registration dossier for each section consists of administrative records and data necessary to prove the quality, safety and ef-ficacy of veterinary medicines. However, due to the extremely complex sub-ject, with which the quality, safety and effica-cy of veterinary medicines is proved, as well as with a diverse range of products there is a need for additional laws in order to specifi-cally regulate certain segments in this area. Agency is paying special attention to veterinary medicines that may indirectly affect the food, and to a large extent the safety of veterinary medicines also relates to security of people. In cooperation with the Ministry of Agricul-ture and Enviromental Protection of the Re-publik of Serbia, that is, the Veterinary Direc-torate we have made significant progress in the area of checking the quality of medicines on the market that has resulted in appropri-ate regulatory actions. In addition, the Agency will contribute to the safety of animals through intensive monitor-ing and providing information on the adverse medicines reactions by developing pharma-covigilance system, as is already done for medicines for human use.

3.3. Ve te ri nar ski le ko viU okvi ru Agen ci je postoji Ve te ri nar ski sek tor ko ji je nad le žan za sta vlja nje u pro met ve te-ri nar skih le ko va, ob no ve i va ri ja ci je, za tim za kli nič ka is pi ti va nja, fa r ma ko vi gi lan cu ve te ri-nar skih le ko va i da va nje struč nih mi šlje nja dok se la bo ra to rij ska kon tro la kva li te ta ve te-ri nar skih le ko va oba vlja u Na ci o nal noj kon-trol noj la bo ra to ri ji Agen ci je.Pro pi sa na struk tu ra re gi stra ci o nog do si jea za ve te ri nar ske le ko ve je po de lje na na dve sek-ci je pre ma vr sti le ko va: fa r ma ce ut ski i imu-no lo ški le ko vi. Re gi stra ci o ni do si je za obe sek ci je sa sto ji se od ad mi ni stra tiv nih po da ta ka i neo p hod nih po da ta ka ko jima se do ka zu je kva li tet, bez-bed nost i efi ka snost ve te ri nar skih le ko va. Me đu tim, zbog iz ra zi to slo že ne ma te ri je ko jom se do ka zu ju kva li tet, bez bed nost i efi ka snost ve te ri nar skih le ko va, kao i ve o ma ra zno vr snog di ja pa zo na pro iz vo da po sto ji po tre ba da se do dat nim pod za kon skim ak ti ma spe ci fič no re-gu li šu po je di ni seg men ti u ovoj obla sti.Agen ci ja na ro či tu pa žnja po sve ću je ve te ri-nar skim le ko vi ma ko ji po sred no mo gu uti ca ti na hra nu, te se u ve li kom obi mu bez bed nost ve te ri nar skih le ko va od no si ta ko đe i na bez-bed nost lju di.U sa rad nji sa Mi ni star stvom po ljo pri vre de i zaštite životne sredine Republike Srbije, od no-sno Upra vom za ve te ri nu uči ni li smo i zna čaj ne po ma ke na pod ruč ju pro ve re kva li te ta lekova iz pro me ta ko ja je re zul ti ra la od go va ra ju ćim re gu-la tor nim ak ci ja ma.Na da lje, Agen ci ja će do pri ne ti si gur no sti ži-vo ti nja in ten ziv nim pra će njem i in for mi sa-njem o ne že lje nim efek ti ma le ko va raz vi ja-njem si ste ma fa r ma ko vi gi lan ce, kao što je to već uči ni la za le ko ve za hu ma nu upo tre bu.

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3.4. Post-registration activities

• PharmacovigilanceMedicines and Medical Devices Agency of Serbia, through the implementation of stan-dards of good practice in pharmacovigilance activities organizes and carries out continu-ous monitoring of adverse drug reactions: • Through the spontaneously reporting of

adverse reactions to medicines, • Through collecting and evaluating health

care professionals reports on adverse effects during treatment of patients,

• Through reporting of adverse reactionsduring clinical trials and,

• Throughevaluationofperiodic reportsonadverse reactions to medicines in the post-marketing period provided in accordance with the regulations by responsible person for pharmacovigilance of medicine manu-facturers (Periodic Safety Update Reports - PSURs).

The EU regulation volume 9 is fully implement-ed within the Agency, which relates to pharma-covigilance of medicines for human and also on Pharmacovigilance for veterinary medicines, as well as the guidelines of the International Con-ference on Harmonization (ICH). National Pharmacovigilance Centre (NPC) also has continuous collaboration and connection through vigibase with the World Health Orga-nization Collaborating Center for Internation-al Drug Monitoring in Uppsala, Sweden (The Uppsala Monitoring Centre - UMC). Experts of the NPC regularly attend and contribute to informational and educational events in the area, as well as the annual meetings of the member countries of the International Centre in Uppsala and others.Assessment of medicine safety profile is a valid precondition for the implementation of a rational (efficient, safe and cost-effective) pharmacotherapy.

3.4. Po stre gi stra ci o ne ak tiv no sti

• Fa r ma ko vi gi lan caAgen ci ja za le ko ve i medicinska sredstva Sr bi je, pri me nom stan dar da do bre prak se u fa r ma ko vi gi lan ci vr ši po slo ve or ga ni zo va nog i kon ti nu i ra nog pra će nja ne že lje nih dej sta va le ko va: • krozsponatnoprijavljivanjeneželjenihreak­

ci ja na le ko ve,• prikupljanjem i procenom prijava zdrav­

stve nih rad ni ka o ne že lje nim re ak ci ja ma u to ku le če nja bo le sni ka,

• prijavljivanjem neželjenih reakcija u tokukli nič kih is pi ti va nja i

• procenom periodičnih izveštaja o neže­lje nim re ak ci ja ma na le ko ve u post mar-ke tin škom pe ri o du do sta vlje nih u skla-du sa pro pi si ma od stra ne od go vor nih li ca za fa r ma ko vi gi lan cu pro iz vo đa ča le ko va (Pe ri o dic Sa fety Up da te Re ports - PSURs).

U Agen ci ji se u pot pu no sti spr o vo di vo lu men 9 pro pi sa EU, ko ji se od no si na fa r ma ko vi gi-lan cu le ko va u hu ma noj, a ta ko đe i na fa r ma-ko vi gi lan cu le ko va u ve te ri nar skoj me di ci ni, kao i smer ni ce Me đu na rod ne kon fe ren ci je o ha r mo ni za ci ji (ICH). Na ci o nal ni cen tar za fa r ma ko vi gi lan cu (NCF) je ta ko đe u kon ti nu i ra noj sa rad nji i ve zi po-sred stvom vi gi ba ze sa ko la bo ra tiv nim cen-trom Svet ske zdrav stve ne or ga ni za ci je za pra će nje ne že lje nih re ak ci ja le ko va u Up sa-li, Švedska (The Uppsala Monitoring Centre - UMC). Struč nja ci NCF-a re dov no pri su stvu-ju i doprinose in for ma tiv nim i edu ka tiv nim sku po vi ma u ovoj obla sti, kao i na go di šnjim sa stan ci ma ze ma lja čla ni ca Me đu na rod nog cen tra u Up sa li i dru gih. Pro ce na bez bed no snih pro fi la le ko va je va-ljan pred u slov za spr o vo đe nje ra ci o nal ne (efi ka sne, bez bed ne i eko no mič ne) fa r ma ko-te ra pi je.

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Implementation of principles of modern clini-cal pharmacology, clinical pharmacy, phar-macokinetics, pharmacotherapy and phar-macoepidemiology is imperative to achieve the rational use of medicines. NPC, through recording and evaluating all reported adverse reactions to medicines, by assessment of the relationships between the use of medicines / medical devices and adverse reactions, identification of poten-tial signals, identifying risk factors, estimate the incidence, as well as making other sig-nificant periodic analysis of reported adverse reactions, contributes that applied medicine therapy ensures the achievement of the de-sired therapeutic benefit with minimal risk of adverse drug reactions.

Results of spontaneous reporting to the Agency’s National Pharmacovigilance Centre.

• Information about medicines, monitoring of consumption and marketing and counterfeit medicines

Ways of informing professional and general public on medicinal products and medical devices are implemented through the activi-ties of the National Center for Information on Medicines and Medical Devices, as well as through modern web presentation on the ac-tivities of the Agency at the address www.al-ims.gov.rs.Good information practices and within it the se-lection of reliable information about medicines and medical devices in today-present hyperin-flation of medicines is a Conditio sine qua non for the proper and safe use of medicines in the

Im ple men ta ci ja prin ci pa sa vre me ne kli nič ke fa r ma ko lo gi je, kli nič ke fa r ma ci je, fa r ma ko ki-ne ti ke, fa r ma ko te ra pi je i fa r ma ko e pi de mi o lo-gi je pred sta vlja im pe ra tiv za po sti za nje ra ci-o nal ne pri me ne le ko va.NCF, evi den ci jom i pro ce nom svih pri ja vlje-nih ne že lje nih re ak ci ja na le ko ve, pro ce nom uzr oč no-po sle dič ne po ve za no sti iz me đu pri-me ne le ka/me di cin skog sred stva i ne že lje-nih re ak ci ja, iden ti fi ka ci jom po ten ci jal nih sig-na la, utvr đi va njem fak to ra ri zi ka, pro ce nom in ci den ci je, kao i iz ra dom dru gih zna čaj nih pe ri o dič nih ana li za pri ja vlje nih ne že lje nih re-ak ci ja, do pri no si da pri me nje na fa r ma ko te ra-pi ja obez be di po sti za nje že lje nog te ra pij skog efek ta uz mi ni ma lan ri zik od ne že lje nih re ak-ci ja le ko va.

Re zul ta ti spon ta nog pri ja vlji va nja Na ci o nal-nom cen tru za fa r ma ko vi gi lan cu Agen ci je:

Go di na / Year 2005. 2006. 2007. 2008. 2009. 2010. 2011. 2012. 2013.

Broj pri ja va / Numbers of reports

102 206 337 423 572 781 962 1179 1173

• In for ma ci je o le ko vi ma, pra će nje po tro šnje i pro me ta i la žni le ko vi

Na či ni in for mi sa nja struč ne i op šte jav no-sti o le ko vi ma i me di cin skim sred stvi ma se spr o vo de kroz ak tiv no sti Na ci o nal nog cen-tra za in for ma ci je o le ko vi ma i me di cin skim sred stvi ma, kao i kroz sa vre me nu web pre-zen ta ci ju o ak tiv no sti ma Agen ci je na adre si www.alims.gov.rs. Do bra in for ma ci o na prak sa i u okvi ru nje se-lek ci ja po u zda nih in for ma ci ja o le ko vi ma i me di cin skim sred stvi ma u da nas pri sut noj hi pe rin fla ci ji le ko va je Con di tio si ne qua non za ade kvat nu i bez bed nu upo tre bu le ko va u pre ven ci ji, di jag no sti ci, te ra pi ji i re ha bi li ta ci ji u hu ma noj i ve te ri nar skoj me di ci ni.

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prevention, diagnosis, treatment and rehabili-tation in human and veterinary medicine. Agency experts on the basis of access to modern databases provide reliable and se-cure information about medicines and medi-cal devices, and guidance to patients and health care professionals for their use in a rational and cost-effective manner. In order to promote the safe use of medicines and medical devices the information for the database within the integrated information system are collected and evaluated, and publications are prepared (register, and phar-macotherapeutic guide and others).In order to perform pharmacoepidemiological and pharmacoeconomic research the Agency monitors marketing and consumption of medicines and medical devices. The Agency regularly provides information on the consumption of medicines, issued permits for clinical trials, marketing authorization, re-newal and variation of licenses for marketing authorization, and withdrawal from the mar-ket of medicines and medical devices, about the side effects of medicines, rational use of medicines, and others. The new ways of global trading and condi-tions of free trade have led to an overall in-crease in production all medicines on the world market, which created favorable condi-tions for the production of substandard and fake medicines (counterfeit drugs). Substandard medicine is an original product which does not meet the set of quality specifi-cations, resulting in inefficiency of medicine and endangering the patient. Substandard medicine may be result of negligence, human error, insuf-ficient human and financial resources or coun-terfeiting. Fake medicines are part of a broader phenom-enon of substandard medicines. They occur as a result of the deliberate and fraudulent mark of its identity and/or source.Counterfeiting of medicines means deliber-ately wrong labeling of finished medicines or ingredients used in their manufacture in terms of their identity, composition and/or origin.

Struč nja ci Agen ci je na osno vu pri stu pa sa vre-me nim ba za ma po da ta ka pru ža ju po u zda ne i bez bed ne in for ma ci je o le ko vi ma i me di cin-skim sred stvi ma, kao i sa ve te pa ci jen ti ma i zdrav stve nim struč nja ci ma za nji ho vu upo tre-bu na ra ci o na lan i eko no mi čan na čin.U ci lju pro mo ci je bez bed ne upo tre be le ko va i me di cin skih sred sta va pri ku plja ju se i pro ce-nju ju in for ma ci je za ba zu po da ta ka u okvi ru in te gral nog in for ma ci o nog si ste ma, i pri pre-ma ju pu bli ka ci je (re gi star, fa r ma ko te ra pij ski vo dič i dr.).U ci lju fa r ma ko e pi de mi o lo ških i fa r ma ko e ko-nom skih is tra ži va nja Agen ci ja pra ti pro met i po tro šnju le ko va i me di cin skih sred sta va.Agen ci ja re dov no da je in for ma ci je o po tro-šnji le ko va, iz da tim do zvo la ma za kli nič ka is pi ti va nja, dozvolama za sta vlja nje u pro-met, ob no va ma i va ri ja ci ja ma do zvo la za sta vlja nje u pro met, kao i po vla če nju iz pro-me ta le ko va i me di cin skih sred sta va, o ne-že lje nim dej stvi ma le ko va, ra ci o nal noj upo-tre bi le ko va i dru ge.No vi glo bal ni na čin tr go va nja i uslo vi slo bod-ne tr go vi ne do ve li su do ukup nog po ve ća nja pro iz vod nje svih le ko va na svet skom tr ži štu, što je stvo ri lo po volj ni je uslo ve i za pro iz vod-nju sub stan dard nih i la žnih le ko va (co un ter-fe it drugs).Sub stan dard ni lek je ori gi nal ni pro iz vod ko ji ne od go va ra po sta vlje noj spe ci fi ka ci ji kva li te-ta, što ima za po sle di cu ne e fi ka snost le ka i do vo di u opa snost pa ci jen ta. Sub stan dard ni lek mo že da bu de po sle di ca ne mar no sti, ljud-ske gre ške, ne do volj nih ljud skih i fi nan sij skih sred sta va ili fal si fi ko va nja. La žni le ko vi pred sta vlja ju deo ši reg fe no me na sub stan dard nih le ko va. Na sta li su kao po sle-di ca na mer nog i la žnog ozna ča va nja obe lež ja nje go vog iden ti te ta i/ili po re kla.Fal si fi ko va nje le ko va ozna ča va na mer no po-gre šno obe le ža va nje go to vih le ko va ili sa sto-ja ka ko ji se ko ri ste u nji ho voj pro iz vod nji u smi-slu nji ho vog iden ti te ta, sa sta va i/ili po re kla.Mo gu se fal si fi ko va ti i za šti će ni i ge ne rič ki pro-iz vo di, a fal si fi kat mo že da bu de pro iz vod sa: • is prav nim sa stoj ci ma;• po gre šnim sa stoj ci ma;

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Protected and generic products can be coun-terfeited and counterfeit products may have: • Rightingredients;• Wrongingredients;• Noactiveingredients;• Active ingredients in insufficient quanti-

ties or product packed in fake packaging. In relation to this, health care professionals in all areas of practice should: • Respect principles of Good Pharmacy

Practice, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), etc.;

• Buymedicines fromtrustedsourcesonly,paying at the same attention to their stor-age conditions before buying, as well as in the supply chain;

• Alarming about the differences in qualitypackaging, labeling or Patient information leaflet, as well as the physical appearance of medicines;

• Reportanycaseofdoubt toauthoritativestate bodies, whether it is an absence of expected therapeutic effect or that a false medicine is offered or delivered and isolate and not issue every medicine that is sus-pected to be false, and to cooperate with investigators to find the source of supply.

Protection of the population from the use of substandard and poor quality medicines and fake medicines, according to the recommen-dations of the World Health Organization, is one of ALIMS goals and in this regard we have close cooperation with other institutions in charge of this in Serbia, but also on inter-national level.

• Advertising of medicines and medical devices

Medicines and medical devices advertising is every form of providing general and profes-sional public with the accurate information about these products in order to encourage

• bez ak tiv nih sup stan ci;• sa ak tiv nim sup stan ca ma u ne do volj nim

ko li či na ma ili pro iz vod upa ko van u la žno pa ko va nje.

S tim u ve zi zdrav stve ni rad ni ci u svim obla-sti ma prak se tre ba da: • po štu ju prin ci pe Do bre apo te kar ske prak-

se, Do bre pro iz vo đač ke prak se (GMP), Dobre distributivne prakse (GDP), itd.;

• kupuju lekove samo iz pouzdanih izvora,obra ća ju ći pri tom pa žnju na nji ho ve uslo ve ču va nja pre ku po vi ne, kao i u lan cu snab de-va nja;

• alarmiraju razlike u kvalitetu pakovanja,obe le ža va nja ili uput stva za upo tre bu, kao i u fi zič kom iz gle du le ko va;

• državnimmerodavnimtelimaprijavesvakislu čaj sum nje, bi lo da je u pi ta nju od su stvo oče ki va nog te ra pij skog efek ta ili da je la žni lek po nu đen ili do sta vljen i izo lu ju i ne iz-da ju sva ki lek za ko ji se sum nja da je la žan i da sa ra đu ju sa is tra ži te lji ma ka ko bi se pro na šao iz vor snab de va nja.

Za šti ta sta nov ni štva od upo tre be sub stan-dard nih i le ko va lo šeg kva li te ta, kao i la žnih le ko va, a u skla du sa pre po ru ka ma Svet ske zdrav stve ne or ga ni za ci je, jedan od ciljeva ALIMS i u tom pogledu ostvarujemo blisku saradnju sa nadležnim institucijama u Srbiji ali i na međunarodnom planu.

• Ogla ša va nje le ko va i me di cin skih sred sta va

Ogla ša va nje le ko va i me di cin skih sred sta va je sva ki ob lik da va nja isti ni tih in for ma ci ja o ovim proizvodima op štoj i struč noj jav no sti

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the prescribing and marketing of medicines and medicinal devices, their supply, sale and consumption. Since 2010, The Agency has a jurisdiction in the approval of advertising of medicines and medical devices.The Agency issues authorizations for:1. Medicinal product advertising through the

media, including the Internet, advertising in public areas and other forms of advertising (mail, visits, etc.);

2. Promotion of medicinal products to health care and veterinary professionals who pre-scribe medicinal products, at professional conferences, in professional journals and other forms of promotion;

Agency approves material intended for pro-fessional public (health care and veterinary professionals who prescribe medicines, phar-macists and other professionals in the field of production and distribution of medicines to wholesalers and retailers, as well as the organization of mandatory health care insur-ance) as well as the general public (citizens of the Republic of Serbia ).

According to the Law, it is forbidden to adver-tise medicinal products:- That do not have a marketing authorization,

or whose marketing authorization has ex-pired;

- In a misleading way, and suggest that the safety and efficacy of a medicinal product are secured by its natural origin;

- Through describing the disease and suc-cess of a treatment as to suggest an indi-vidual treatment;

- Presenting the success of a medicinal prod-uct treatment in an inadequate and spec-tacular way, by displaying pictures, etc.;

- In a way that suggests that a medicinal product can be classified as food, cosmet-ics, or other items that have general use;

- In order to encourage prescribing and issu-ing of a medicinal product by giving or prom-ising financial, material or other benefits.

ra di pod sti ca nja pro pi si va nja i pro me ta le ko-va i me di cin skih sred sta va, njihovog snab de-va nja, pro da je i po tro šnje. Od 2010. go di ne, Agen ci ja je do bi la nad le žnost u odo bra va nju ogla ša va nja le ko va i me di cin skih sred sta va.Agen ci ja da je odo bre nja za: 1) re kla mi ra nje medicinskih proizvoda pu tem

sred sta va jav nog in for mi sa nja, uklju ču ju ći i in ter net, re kla mi ra nje na jav nim me sti ma i dru ge ob li ke re kla mi ra nja le ka (po štom, po se ta ma i sl.);

2) pro mo ci ju medicinskih proizvoda zdrav-stve nim i ve te ri nar skim rad ni ci ma ko ji pro pi su ju le ko ve, i to oba ve šta va njem na struč nim sku po vi ma, u struč nim ča so pi si-ma i dru gim ob li ci ma pro mo ci je.

Agen ci ja odo bra va ma te ri jal ko ji je na me njen ka ko struč noj jav no sti (zdrav stve ni i ve te ri-nar ski rad ni ci ko ji pro pi su ju le ko ve, di plo mi-ra ni fa r ma ce u ti i dru ga struč na li ca u obla sti pro iz vod nje i pro me ta le ko va na ve li ko i ma lo, kao i u or ga ni za ci ji oba ve znog zdrav stve nog osi gu ra nja) ta ko i op štoj jav no sti (gra đa ni Re pu bli ke Sr bi je).

Pre ma za ko nu, za bra nje no je ogla ša va nje le ka:- ko ji ne ma do zvo lu za lek, od no sno či ja je do-

zvo la za lek pre sta la da va ži; - ko je do vo di u za blu du, od no sno na vo di na

za klju čak da su bez bed nost i efi ka snost le-ka osi gu ra ni nje go vim pri rod nim po re klom;

- ko jim se opi su je bo lest i us pe si le če nja ta ko da na vo de na sa mo le če nje;

- na neo d go va ra ju ći i sen za ci o na li stič ki na čin o nje go vim us pe si ma u le če nju, pri ka zi va-njem sli ka i dr.;

- ko jim se na vo di na za klju čak da lek spa da u hra nu, ko zme ti ku ili dru ge pred me te op šte upo tre be;

- ra di pod sti ca nja na pro pi si va nje i iz da va nje le ko va da va njem ili obe ća va njem fi nan sij-skih, ma te ri jal nih ili dru gih ko ri sti.

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Also, it is forbidden to advertise to the gen-eral public: - Medicinal products that are issued with a

prescription;- Medicinal products that are issued at the

expense of health care insurance;- Medicinal products containing opiates or psy-

chotropic substances, medicinal products for tuberculosis, for infectious diseases...

Promotional materials designed for the profes-sional public must contain basic information on the medicine from marketing authorization, that is, the data which is consistent with the Sum-mary of Product Characteristics, as well as in-formation relating to the regimen of medicines issuance. These data must be accurate, up to date, verifiable and sufficiently complete to the recipient to provide the possibility of forming an opinion on the therapeutic value of a medicine, and well as to have the date when they were made or when they were last revised. Medicines obtained without a prescription can be advertised in the media and so on, but the information about their activities can be pro-vided only in accordance with the Summary of Product Characteristics, which is integral part of the marketing authorization. Advertising of medicines obtained without a prescription has to be objective and not misleading and the Agency prepares a list of medicines that can be advertised in this way.

Ta ko đe, za bra nje no je re kla mi ra nja le ka op-štoj jav no sti:- ko ji se iz da ju uz re cept;- ko ji se iz da ju na te ret sred sta va zdrav stve-

nog osi gu ra nja;- ko ji sa dr že opoj ne dro ge ili psi ho trop ne

sup stan ce, le ko va za tu ber ku lo zu, in fek tiv-ne bo le sti...

Pro mo tiv ni ma te ri jal na me njen struč noj jav-no sti mo ra da sa dr ži osnov ne po dat ke o le-ku iz do zvo le za lek, od no sno po dat ke ko ji su uskla đe ni sa Sa žet kom ka rak te ri sti ka le ka, kao i po dat ke ko ji se od no se na re žim iz da-va nja le ka. Ovi po da ci mo ra ju bi ti tač ni, ažu-ri ra ni, pro ver lji vi i u do volj noj me ri pot pu ni da pri ma lac na osno vu njih mo že da fo r mi ra svo-je mi šlje nje o te ra pij skoj vred no sti od re đe nog le ka, kao i da ima ju da tum ka da su sa či nje ni ili ka da su po sled nji put re vi di ra ni. Le ko vi ko ji se iz da ju bez re cep ta se mo gu re-kla mi ra ti u sred stvi ma jav nog in for mi sa nja itd., ali mo gu se da va ti in for ma ci je o nji ho vom de lo va nju sa mo u skla du sa Sa žet kom ka rak-te ri sti ka le ka ko ji je sa stav ni deo do zvo le za lek. Re kla mi ra nje le ko va ko ji se iz da ju bez re-cep ta mo ra bi ti objek tiv no i ne sme do vo di ti u za blu du a Agen ci ja utvr đu je li stu le ko va ko ji se mo gu re kla mi ra ti na ovaj na čin.

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3.5. Clinical trialsIn the development policy of the Agency a special place is devoted to the interest of the Republic of Serbia to develop in Serbia the necessary infrastructure to conduct clinical trials of expensive and innovative medicines, which would increase the availability of such therapy and diagnostics to patients. Prior to the commencement of clinical trial, sponsor must submit to the Agency a request for the approval of clinical trial of medicine and documentation, which includes: a summary of the nature and properties of medicines, informa-

tion on research carried out in order to define its pharmacological and toxicological properties, clinical experience, the proposed trial protocol, a list of all research-ers and institutions in-volved in the trial and other documents relat-ing to the protection of health of subjects. The Agency does not take into consideration a request for approval of clinical trial if the Ethics Committee of the insti-tution where the clinical trial will be conducted did not give a favorable opinion about it.If the conditions laid down by the law and regulations governing enforcement of the law are met, the Agency issues an authoriza-tion for the conduct of clinical trial. Supervision of the conduct of clinical trial is conducted by the Agency in accordance with the law, clini-

3.5. Kli nič ka is pi ti va njaU po li ti ci raz vo ja Agen ci je po seb no me sto za u zi ma in te res Re pu bli ke Sr bi je da se u Sr bi ji raz vi je neo p hod na in fra struk tu ra za spr o vo đe nje kli nič kih is pi ti va nja sku pih i ino va tiv nih le ko va, či me bi se pa ci jen ti ma po ve ća la do stup nost ova kve te ra pi je i di-jag no sti ke.Pre po čet ka spr o vo đe nja kli nič kog is pi ti va-nja le ka spon zor mo ra da pod ne se Agen ci ji zah tev sa odo bre nje kli nič kog is pi ti va nja le ka i do ku men ta ci ju, ko ja sa dr ži: sa že tak o pri-ro di i oso bi na ma le ka, in for ma ci je o spr o ve-de nim is tra ži va nji ma ra di de fi ni sa nja nje-go vih fa r ma ko lo ških i tok si ko lo ških svoj sta-va, kli nič ko is ku stvo, pro to kol pred lo že nog is pi ti va nja, spi sak svih is tra ži va ča i usta no va uklju če nih u is pi ti va nje i osta la do ku men ta ko-ja se od no se na za šti-tu zdra vlja is pi ta ni ka. Agen ci ja ne uzi ma u raz ma tra nje zah tev za odo bre nje kli nič kog is-pi ti va nja uko li ko Etič ki od bor usta no ve u ko joj će se kli nič ko is pi ti va-nje spr o vo di ti ni je dao po zi tiv nu od lu ku o nje-mu.Ako su is pu nje ni uslo-vi pro pi sa ni za ko nom i pro pi si ma do ne tim za spr o vo đe nje za-ko na, Agen ci ja iz da je do zvo lu za spr o vo đe-nje kli nič kog is pi ti va-nja le ka.Kon tro lu spr o vo đe nja kli nič kog is pi ti va nja le-ka vr ši Agen ci ja u skla-du sa za ko nom, pro to-

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cal trial protocol and Good Clinical Practice guidelines. If there is a serious and unexpected adverse reaction or serious adverse event during the conduct of clinical trial sponsor must im-mediately notify the Agency and the ethics committee of the legal entity or the health care institution where the trial is performed. In such cases, the Agency may propose to the Ministry of Health to suspend or prohibit the conduct of clinical trial, particularly if it is determined that there was non-compliance of the clinical trial protocol and Good Clinical Practice guidelines.

The Agency is actively involved in the educa-tion of professional and general public about the importance of clinical trials and for that purpose conducted information campaigns in the media and published a brochure for par-ticipants and potential participants in clinical trials.

ko lom kli nič kog is pi ti va nja i Smer ni ca ma Do-bre kli nič ke prak se.Ako do đe do ozbilj ne i neo če ki va ne ne že lje-ne re ak ci je ili ozbilj nog ne že lje nog do ga đa-ja u to ku spr o vo đe nja kli nič kog is pi ti va nja le ka spon zor je du žan da od mah oba ve sti Agen ci ju i etič ki od bor prav nog li ca, od no-sno zdrav ste ne usta no ve u ko joj se spr o vo-di kli nič ko is pi ti va nje. U ova kvim slu ča je vi-ma, Agen ci ja mo že da pred lo ži Mi ni star stvu zdra vlja da ob u sta vi ili za bra ni spr o vo đe nje kli nič kog is pi ti va nja le ka, po seb no uko li ko je utvr đe no da je po sto ja lo ne po što va nje pro-to ko la kli nič kog is pi ti va nja ili Smer ni ca Do-bre kli nič ke prak se.

Agen ci ja ak tiv no ra di na edu ka ci ji struč ne i op šte jav no sti o zna ča ju kli nič kih is pi ti va nja i u tu svr hu je spr o vodila in for ma tiv ne kam-pa nje u me di ji ma i pu bli ko va la bro šu ru za uče sni ke i po ten ci jal ne uče sni ke u kli nič kim is pi ti va nji ma.

Go di na / Year Broj odo bre nih kli nič kih is pi ti va nja / Number of approved clinical trials

2008. 1152009. 942010. 842011. 922012. 912013. 105

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4. Laboratory quality controlNational Control Laboratory (NCL) is an orga-nizational unit of ALIMS that performs quality control of medicines and medical devices. Quality control is performed by highly trained professionals, of whom a significant num-ber underwent planned continuous training in accredited European laboratories of EU countries. The training was organized in col-laboration with the European Directorate for the Quality of Medicines and Health Care of Council of Europe (EDQM). Laboratory control is carried out in accor-dance with the requirements of the European Pharmacopoeia, national pharmacopoeia or in accordance to other recognized pharmaco-poeias or validated methods of analysis. NCL is equipped with the most modern equipment that is fully qualified, calibrated and validated in accordance with up to date requirements.Within the NCL there are Physico-chemical laboratory, Biological Laboratory (in which there are Microbiological laboratory and Labo-ratory for pharmacological control) and the Quality Management and Support Unit.

Physico-chemical laboratory

In the physico-chemical laboratory identifi-cation tests are performed, determination of content of active substance, release rate of the active substance (Dissolution), testing the degree of purity, uniformity of dosage forms, disintegration Karl Fisher - determination of moisture content, pH determination, deter-mination of the nitrogen content, general test and other pharmacopoeial tests.Modern equipment is used to perform these tests: liquid chromatography with high pres-sure and with different detectors (HPLC / VWD; HPLC / DAD, HPLC / RID; HPLC / FLD, HPLC / MS); Gas chromatography (GC; GC-HSS), Spectrophotometers; Infrared spectrophotom-eter; Atomic absorption / emission spectro-

4. La bo ra to rij ska kon tro la kva li te taNa ci o nal na kon trol na la bo ra to ri ja (NKL) je or ga ni za ci o na je di ni ca ALIMS ko ja oba vlja kon tro lu kva li te ta le ko va i me di cin skih sred-sta va.Kon tro lu kva li te ta oba vlja ju vi so ko edu ko va-ni struč nja ci, od ko jih je zna ča jan broj pro šao pla ni ra nu kon ti nu i ra nu obu ku u akre di to va-nim evr op skim la bo ra to ri ja ma ze ma lja EU. Obu ka je re a li zo va na u sa rad nji sa Evr op skim di rek to ra tom za kva li tet le ko va i bri gu o zdra-vlju Sa ve ta Evr o pe (EDQM).La bo ra to rij ska kon tro la se vr ši u skla du sa zah te vi ma Evr op ske fa r ma ko pe je, na ci o nal ne fa r ma ko pe je ili u skla du sa dru gim pri zna-tim fa r ma ko pe ja ma ili pro ve re nim me to da ma ana li ze.NKL je opre mlje na najmodernijom opre mom ko ja je u pot pu no sti kva li fi ko va na, ka li bri sa-na i va li di ra na u skla du sa sa vre me nim zah-te vi ma.U sa sta vu NKL su Fi zič ko-he mij ska la bo ra-to ri ja, Bi o lo ška la bo ra to ri ja (u okvi ru ko je se na la ze mi kro bi o lo ška la bo ra to ri ja i la bo ra to-ri ja za fa r ma ko lo ška is pi ti va nja) i Ode lje nje za upra vlja njem kva li te tom i po dr šku.

Fi zič ko-he mij ska la bo ra to ri ja

U fi zič ko-he mij skoj la bo ra to ri ji iz vo de se te-sto vi iden ti fi ka ci je, od re đi va nje sa dr ža ja ak-tiv ne sup stan ce, br zi na oslo ba đa nja ak tiv ne sup stan ce (Dis so lu tion), is pi ti va nje ste pe na či sto će, ujed na če nost do zi ra nog ob li ka, ras-pa dlji vost Karl Fis her - od re đi va nje sa dr ža ja vo de, od re đi va nje pH, od re đi va nje sa dr ža ja azo ta, op šti te sto vi is pi ti va nja i dru gi fa r ma-ko pej ski te sto vi.Za iz vo đe nje ovih te sto va ko ri sti se sa vre me na opre ma: Teč ni hro ma to gra fi pod vi so kim pri-ti skom sa raz li či tim de tek to ri ma (HPLC/VWD; HPLC/DAD; HPLC/RID; HPLC/FLD; HPLC/MS); Ga sni hro ma to gra fi (GC; GC-HSS); Spek tro fo-to me tri; In fra cr ve ni spek tro fo to me tar; Atom-ski ap sorp ci o ni/emi si o ni spek tro fo to me tri;

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photometers; HPTLC densitometer; Dissolution apparatus; System for testing decay; Systems for titration; Kjeldahl system and others.

Biological Laboratory

Biological Laboratory consists of two labora-tory parts, Pharmacology and Microbiology, equipped with the latest standards for qual-ity control of medicines. In laboratory works professional staff of different educational backgrounds, providing a multidisciplinary approach to each testing of medicine quality. In Biological Laboratory the in vivo and in vitro tests are preformed that include various tests of security, identification and determina-tion of the active components of particularly vulnerable groups of medicines such as the immunobiological medicines (vaccines, blood products, imunosera, etc.).The most modern equipment is used for test-ing, and the tests themselves are performed under strictly defined techniques and proce-dures in compliance with the European Phar-macopoeia and other applicable regulations (sterility, safety, determining the presence of pirogenical substances, determination of bacterial endotoxines, determination of prekallikrein activator, etc.). The Biological Laboratory is dedicated to test-ing of other groups of medicines for human and veterinary use, which involves rigorous testing of microbiological purity and other tests of the biological properties of medicines. The equip-ment used to perform all the tests is subject to regular qualification and calibration, and labo-ratory conditions are thoroughly controlled in accordance with the latest principles of Good Laboratory Practice (GLP). Biological Laboratory also has modernly equipped vivarium used to perform in vivo tests.

HPTLC den zi to me tar; Dis so lu tion apa rat; Si-stem za is pi ti va nje ras pa dlji vo sti; Si ste mi za ti tra ci ju; Kjel dahl si stem i drugi.

Bi o lo ška la bo ra to ri ja

Bi o lo šku la bo ra to ri ju či ne dve la bo ra to rij ske ce li ne, Fa r ma ko lo gi ja i Mi kro bi o lo gi ja, opre-mlje ne pre ma naj sa vre me ni jim stan dar di ma za kon tro lu kva li te ta le ko va. U la bo ra to ri ji ra di struč no ospo so blje no oso blje raz li či tih obra zov nih pro fi la, či me je obez be đen mul ti-di sci pli nar ni pri stup pri li kom sva kog is pi ti va-nja kva li te ta le ko va.U Bi o lo škoj la bo ra to ri ji iz vo de se in vi vo i in vi tro te sto vi ko ji ob u hva ta ju raz li či te te sto ve bez bed no sti, iden ti fi ka ci je i od re đi va nja sa dr-ža ja ak tiv nih kom po nen ti po seb no ose tlji vih gru pa le ko va kao što su imu no bi o lo ški le ko vi (vak ci ne, krv ni de ri va ti, imu no se ru mi i sl.). Za is pi ti va nje se ko ri sti naj sa vre me ni ja opre-ma, a sa ma is pi ti va nja se iz vo de pre ma str-o go de fi ni sa nim teh ni ka ma i pro ce du ra ma uskla đe nim sa Evr op skom fa r ma ko pe jom i dru gim va že ćim re gu la ti va ma (ste ril nost, ne-ško dlji vost, od re đi va nje pri su stva pi ro ge nih sup stan ci, od re đi va nje sa dr ža ja bak te rij skih en do tok si na, od re đi va nje sa dr ža ja pre ka li-krein-ak ti va to ra i sl.). U Bi o lo škoj la bo ra to ri ji vr ši se is pi ti va nje i dru gih gru pa le ko va za hu ma nu i ve te ri nar sku upo tre bu, ko je pod ra zu me va ri go ro zna is pi ti-va nja mi kro bi o lo ške či sto će, i dru ge te sto ve is pi ti va nja bi o lo ških ka rak te ri sti ka le ko va. Oprema koja se koristi za iz vo đe nje svih te-sto va pod le že re dov noj kva li fi ka ci ji i eta lo ni-ra nju, a la bo ra to rij ski uslo vi temeljno su kon-tro li sa ni i u skla du sa naj sa vre me ni jim prin ci-pi ma Do bre la bo ra to rij ske prak se (DLP).Bi o lo ška la bo ra to ri ja ras po la že i sa vre me no opre mlje nim vi va ri ju mom ko ji slu ži za iz vo đe-nje in vi vo te sto va.

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Quality Management and Support Unit

Quality Management and Support Unit takes an active part in planning, organizing and co-ordinating the execution of tasks related to the development, implementation, maintenance and improvement of quality management in the National Control Laboratory (NCL). In accordance with the quality standards re-quirements the Unit performs the following activities: Coordination of activities related to the definition, creation and modification of specifications of items required for NCL (labo-ratory equipment, chemicals, glassware, etc.), as well as the process of receiving control of all items; Coordinates and implements activi-ties in management of laboratory equipment, controls samples, references standards and registration documentation required for labo-ratory testing. This unit also monitors and participates in the implementation of regulations by EU, ICH, and other international guidelines.

European Official Medicines Control Laboratories Network (OMCL Network)

In July 2004, EDQM Tutorial Visit was held as part of EDQM procedures for international accreditation of laboratories within OMCL Network. After the evaluation of QA systems, equipment, expertise of employees in NCL and the information system by expert’s team of EDQM, NCL officially became part of the European OMCL Network.

Activities within OMCL Network:

1. Proficiency Testing Scheme first (PTS) studies - since 2005; The goal is to check the quality of work of European laboratories and to develop mutual trust;

2. Collaborative trials - determining the qua-lity of CRS EP (European Pharmacopoeial

Ode lje nje za upra vlja njem kva li te tom i po dr šku

Ode lje nje za upra vlja nje kva li te tom i po dr-šku ak tiv no uče stvu je u pla ni ra nju, or ga ni-zo va nju i ko or di na ci ji iz vr še nja po slo va ko ji se od no se na raz voj, im ple men ta ci ju, odr-ža va nje i po bolj ša va nje si ste ma upra vlja nja kva li te tom u Na ci o nal noj kon trol noj la bo ra-to ri ji (NKL). U skla du sa zah te vi ma stan dar da kvaliteta ode lje nje oba vlja sle de će ak tiv no sti: Ko or di-ni ra ak tiv no sti ve za ne za de fi ni sa nje, iz ra du i iz me nu spe ci fi ka ci ja ar ti ka la po treb nih za NKL (la bo ra to rij ska opre ma, he mi ka li je, la bo-ra to rij sko sta klo itd.), kao i pro ces pri jem ne kon tro le svih ar ti ka la; Ko or di ni ra i spr o vo di ak tiv no sti ve za ne za upra vlja nje la bo ra to rij-skom opre mom, kon trol nim uzor ci ma, re fe-rent nim stan dar di ma i re gi stra ci o nom do ku-men ta ci jom neo p hod nim za la bo ra to rij sko is pi ti va nje.Ovo ode lje nje ta ko đe pra ti i uče stvu je u spr o-vo đe nju pro pi sa EU, ICH i dru gih me đu na rod-nih smer ni ca.

Evr op ska mre ža zva nič nih kon trol nih la bo ra to ri ja (OMCL Mre ža)

U ju lu me se cu 2004. go di ne odr žan je EDQM Tu to rial Vi sit kao deo EDQM pro ce du re za me-đu na rod nu akre di ta ci ju la bo ra to ri ja u okvi ru OMCL mre že. Na kon pro ce ne QA si ste ma, opre me, struč no sti za po sle nih u NKL-u i in-for ma ci o nog si ste ma od stra ne eks pert skog ti pa EDQM-a, NKL zva nič no po sta je deo evr-op ske OMCL mre že.

Ak tiv no sti u okvi ru OMCL mre že:

1. Pro fi ci ency Te sting Sche me (PTS) stu di es – od 2005. go di ne; cilj je pro ve ra kva li te ta ra da Evr op skih la bo ra to ri ja i raz vi ja nje me-đu sob nog po ve re nja;

2. Col la bo ra ti ve tri als – utvr đi va nje kva li-te ta EP CRS (Euro pean Phar ma co po e ial

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Commission of Reference Substances) - since 2006;

3. Collaborative Market Surveillance Studies - goal is to check the quality of medicines that are on the European market, since February 2007;

4. Suspicious Unknown Products (unknown drug samples) - identification of unknown active ingredients and then determination of the content in the submitted sample.

NCL participates in setting the basic European standards by which medicines are controled that is, the development of monographs of the European Pharmacopoeia, and the Agency has a representative in the group 15 for vaccines and serums in the EDQM. Finally, NCL experts regularly attend annual meetings of OMCL Network organized by EDQM.

Com mis sion of Re fe ren ce Sub stan ces) - od 2006. go di ne;

3. Col la bo ra ti ve Ma r ket Su r ve il lan ce Stu di-es – cilj je pro ve ra kva li te ta le ko va ko ji se na la ze na Evr op skom tr ži štu; od fe bru a ra 2007. go di ne;

4. Su spi ci o us Unk nown Pro ducts (Ne po zna-ti uzor ci le ko va) – iden ti fi ka ci ja ne po zna te ak tiv ne sup stan ce i po tom od re đi va nje sa-dr ža ja u do sta vlje nom uzor ku.

NKL uče stvu je i u po sta vlja nju osnov nog evrop skog stan dar da na osno vu ko ga se kon-tro li šu le ko vi, od no sno u raz vo ju mo no gra fi ja Evr op ske fa r ma ko pe je, a Agen ci ja ima pred-stav ni ka i u gru pi 15 EDQM & He al thCa re za vak ci ne i se ru me.Ko nač no, eks per ti NKL-a re dov no pri su stvu ju go di šnjim sa stan ci ma OMCL mre že u or ga ni-za ci ji EDQM-a.

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5. Quality Management in ALIMSQuality management occupies an important place in the activities of Medicines and Medi-cal Devices Agency of Serbia, which, from its inception is actively working on the imple-mentation and improvement of all manage-ment systems. On August 8th, 2006, ALIMS successfully certified its Quality Management System (QMS), becoming the second agency in Eu-rope that has achieved international certifica-tion of its QMS. Before the Serbian Agency certification was acheived by the Dutch Medi-cines Agency (Medicines Evaluation Board - MEB) March 23rd, 2006.The quality management system is based on a process basis, ensuring continuous im-provement of all activities, and thus improves the quality of professional performance of the Agency. Special significance in the Agency has a quali-ty system in accordance with the requirements of ISO 17025:2005 standard, through which the activities in the process of laboratory qual-ity control of medicines are constantly being improved. NCL was officially included in the list of accredited laboratories by Acreditation Body of Serbia on April 26th 2013. By imple-mentation of requirements of these standards the National Control Laboratory has secured a leading position in the region, as well as a significant role in OMCL Network.Since the basic commitment of employees in the Agency is to continuously improve regu-latory performance in order to ensure qual-ity, safe and effective medicines and medical devices for patients in Serbia, each year we strive to achieve this through the promotion of cooperation with Agency’s clients and improve the quality of services we provide. The analy-sis of data provides a continuous increase in the satisfaction of our customers, while adopt-ing constructive suggestions and criticism by clients in order to achieve quality of coopera-tion and transparency in operations.

5. Upra vlja nje kva li te tom u ALIMSUpra vlja nje kva li te tom za u zi ma zna čaj no me sto u po slo va nju Agen ci je za le ko ve i me di cin ska sred stva Sr bi je ko ja, po čev od svog osni va nja ak tiv no ra di na im ple men-ta ci ji i una pre đe nju svih si ste ma me nadž-men ta.ALIMS je 8. av gu sta 2006. go di ne uspe šno se r ti fi ko va la svoj si stem me nadž men ta kva-li te tom (QMS) po stav ši ta ko dru ga agen ci ja u Evr o pi ko ja je ostva ri la me đu na rod nu se r ti-fi ka ci ju svog QMS-a. Pre srp ske agen ci je se-r ti fi ka ci ju je ostva ri la ho land ska agen ci ja za le ko ve (Me di ci nes Eva lu a tion Bo ard – MEB) 23. ma r ta 2006. go di ne.Si stem me nadž men ta kva li te tom se za sni-va na pro ce snom prin ci pu, či me se osi gu ra-va kon ti nu i ra no una pre đe nje avih ak tiv no sti, a sa mim tim i po bolj ša nje kva li te ta struč ne pe r for man se Agen ci je. Po se ban zna čaj u Agen ci ji ima si stem kvali-teta u skla du sa zah te vi ma stan dar da ISO 17025:2005, ko jim se stal no una pre đu ju ak tiv-no sti u po stup ku la bo ra to rij ske kon tro le kva-li te ta le ko va. NKL je 26. aprila 2013. godine i zvanično uvrštena u red akreditovanih laboratorija od strane ATS - Akreditacionog tela Srbije. Im ple men ta ci jom zah te va ovog stran dar da Na ci o nal na kon trol na la bo ra to ri-ja je osi gu ra la vo de će me sto u re gi o nu, kao i zna čaj nu ulo gu u OMCL mre ži.Ka ko je osnov no opre de lje nje za po sle nih u Agen ci ji kon ti nu i ra no una pre đe nje re gu-la tor ne pe r for man se u ci lju obez be đe nja kva li tet nih, bez bed nih i efi ka snih le ko va i me di cin skih sred sta va za pa ci jen te u Sr-bi ji, sva ke go di ne te ži mo da to ostva ri mo kroz una pre đe nje sa rad nje sa kli jen ti ma Agen ci je i po bolj ša nje kva li te ta uslu ga ko je pru ža mo. Ana li zom po da ta ka osi gu ra va mo kon ti nu i ra no po ve ća nje za do volj stva ko ri-sni ka na ših uslu ga, uz isto vre me no usva-ja nje kon struk tiv nih pred lo ga i kri ti ka kli je-na ta u ci lju po sti za nja kva li tet ne sa rad nje i tran spa rent no sti u po slo va nju.

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Also, the quality management activities are aimed at significant international cooperation and coordination of the Agency Management System with the requirements of the Europe-an Medicines Agency that relate to the per-formance of the national regulatory agencies for medicines. Of these activities particularly important is creation of “Strategy of prepa-ration and development of internal capaci-ties of Agency for Implementing Benchmark-ing procedures (BEMA)”, which includes the follo wing areas: organization, assessment of documentation on medicines, pharmacovigi-lance and interaction with inspection bodies. Since the activities of quality management is involved in all aspects of the Agency work, its maintenance and continued development directly contribute to establishing and main-taining high standards in the professional work of the Agency.

In the Agency, the Environmental Mana-gement System (EMS) is implemented in accordance with the requirements of ISO 14001:2004 standard, which has been su-ccessfully recertified in June 2013.EMS is important for ALIMS from several as-pects, out of which the waste management should be pointed out, as well as emissions to water and air, and many other aspects re-lated to the environment. Informing all em-ployees of ALIMS about the importance and ways to protect the environment, but also the education of all visitors in ALIMS is also part of the implementation of this system.Waste management in the Agency began by organizing work procedures, first of haz-ardous waste, and today includes all types of waste generated. Namely, even before

Ta ko đe, ak tiv no sti upra vlja nja kva li te tom zna čaj no su usme re ne ka me đu na rod noj sa rad nji i usa gla ša va nju si ste ma me nadž-men ta Agen ci je sa zah te vi ma Evr op ske agen ci je za le ko ve ko ji se od no se na re gu-la tor nu pe r for man su na ci o nal nih agen ci ja za le ko ve. Od na ve de nih ak tiv no sti na ro či-to je zna čaj no fo r mi ra nje „Stra te gi je pri pre-me i raz vo ja unu tra šnjih ka pa ci te ta Agen ci-je za spr o vo đe nje Ben čmar king pro ce du re (BE MA)“, ko ja ob u hva ta sle de će obla sti: or ga ni za ci ja, pro ce na do ku men ta ci je o le-ko vi ma, fa r ma ko vi gi lan ca i in ter ak ci ja sa in spek cij skim or ga ni ma. Bu du ći da su ak tiv no sti upra vlja nja kva li te-tom in vol vi ra ne u sve seg men te ra da Agen-ci je, nje go vo odr ža va nje i kon ti nu i ra ni raz voj di rekt no do pri no se us po sta vlja nju i odr ža-va nju vi so kih stan dar da u struč nom ra du Agen ci je.

U Agen ci ji je im ple men ti ran i Si stem me-nadž men ta za šti tom ži vot ne sre di ne (EMS), u skla du sa zah te vi ma stan dar da ISO 14001:2004, ko ji je uspe šno re ser ti fi ko-van ju na 2013. go di ne. EMS je zna ča jan za ALIMS sa vi še aspe ka ta, od ko jih tre ba iz dvo ji ti upr av lja nje ot pa dom, emi si je u vo du i va zduh i mno go broj ne dru ge aspek te ve za no za ži vot nu sre di nu. Upo zna-va nje svih za po sle nih u ALIMS o zna ča ju i na-či ni ma za šti te ži vot ne sre di ne, ali i edu ka ci ja svih po se ti la ca ALIMS je ta ko đe deo im ple-men ta ci je ovog si ste ma. Upra vlja nje ot pa dom u Agen ci ji za po če lo je or ga ni zo va njem po slo va po stu pa nja, naj pre sa opa snim ot pa dom, da bi da nas ob u hva ta-lo sve vr ste ot pa da ko ji se ge ne ri še. Na i me, i pre ne go što je ju la 2007. go di ne uve den i se-

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the system of environmental management was introduced and certified, in July 2007 the Agency has demonstrated its commitment to the protection of the environment in a way that the hazardous waste generated in the process of work was taken care of in a secure manner. Waste management is regulated by the standard procedures and guidance sys-tem of environmental management and qual-ity management systems.Pharmaceutical and chemical waste are since 2005 exported to EU countries that have in-cinerators, where the waste is destroyed at temperatures higher than 800 ° C. Exports are carried out in accordance with the principles of the Basel Convention on the Control of Trans-boundary Movements of Hazardous Wastes and their Disposal and the Agency receives certification that the waste is destroyed in an authorized facility. Agency since 2008 has collected and sent for recycling used paper, cardboard and glass.The shift that has been made in protecting the environment in our country in recent years due to the greater involvement of the relevant Ministry encourages and fosters our Agency to constantly seeks improvement of existing processes too.

r ti fi ko van si stem upra vlja nja za šti tom ži vot ne sre di ne, Agen ci ja je de mon stri ra la svo ju po-sve će nost za šti ti ži vot ne sre di ne na taj na čin što je opa san ot pad ko ji na sta je u pro ce si ma ra da, zbri nja va la na si gu ran na čin. Upra vlja-nje ot pa dom re gu li sa no je stan dard nim pro-ce du ra ma i uput stvi ma si ste ma upra vlja nja za šti tom ži vot ne sre di ne i si ste ma upra vlja-nja kva li te tom. Fa r ma ce ut ski i he mij ski ot pad se od 2005. go di ne iz vo ze u ze mlje EU ko je po se du ju in si-ne ra to re, u ko ji ma se ot pad uni šta va na tem-pe ra tu ra ma ve ćim od 800°C. Iz voz se oba vlja u skla du sa prin ci pi ma Ba zel ske kon ven ci je o kon tro li pre ko gra nič nog kre ta nja opa snih ot-pa da i nji ho vom od la ga nju i Agen ci ja do bi ja se r ti fi kat da je ot pad uni šten u ovla šće nom po stro je nju. Agen ci ja od 2008. go di ne sa ku-plja i ša lje na re ci kla žu upo tre blje ni pa pir i ka r ton kao i sta klo. Po mak ko ji je na či njen u za šti ti ži vot ne sre di ne u na šoj ze mlji po sled njih go di na za hva lju ju ći ve ćoj an ga žo va no sti re sor-nog Mi ni star stva ohra bru je i pod sti če da i Agencija stal no te ži una pre đi va nju po sto-je ćih po stu pa ka.

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6. Professional meetings organized by ALIMS - education of expert public The Agency has so far organized a number of conferences with international participa-tion, with the primary aim to educate par-ticipants in the health care system of Serbia. This builds on the tradition of such meetings, beginning from 1972 when the Institute of Pharmacy held its first international meeting called “Comité des Laboratories et services de controle des officiels Medication”.

6. Struč ni sku po vi u or ga ni za ci ji ALIMS - edu ka ci ja struč ne jav no stiAgencija je do sa da or ga ni zo vala ve li ki broj struč nih sku po va sa me đu na rod nim uče šćem sa pr ven stve nim ci ljem edu ka ci je uče sni ka u zdrav stve nom si ste mu Sr bi je. Ovim se na-do ve zu je na tra di ci ju ova kvih sku po va ko ja po či nje od 1972. go di ne ka da je u Za vo du za fa r ma ci ju odr žan pr vi in ter na ci o nal ni skup po ime nu „Co mité des La bo ra to ri es et se r vi ces offi ci els de con tro le des Me di ca ments“.

Simpozijum

Symposium lekovima

on Biosimilar

Medicinal Products

Medicines and Medical Devices

Agency of Serbia is organising

Agencija za lekove i medicinska

sredstva Srbije organizuje

Best Western Hotel M

Belgrade, 24th November 2008

Best Western Hotel M

Beograd 24. novembar 2008.

44

In addition, experts from the Agency are members of many international associations, and regularly participate in relevant meet-ings, conferences and congresses at which they exhibit papers, lectures and represent our country. In the future, the Agency will focus on the education of health professionals in the field of pharmacovigilance in order to increase the number of reports of adverse effects, and these meetings will be accredited by the Health Council of Serbia.

Po red ovo ga, struč nja ci Agen ci je su čla no vi ve li kog bro ja me đu na rod nih udru že nja i aso-ci ja ci ja i re dov no uče stvu ju na re le vant nim sa stan ci ma, sku po vi ma i kon gre si ma na ko-ji ma iz la žu ra do ve, dr že pre da va nja i pred sta-vlja ju na šu ze mlju.U bu duć no sti, Agen ci ja će se fo ku si ra ti na edu ka ci ju zdrav stve nih pro fe si o na la ca u obla sti fa r ma ko vi gi lan ce sa ci ljem po ve ća nja bro ja pri ja va ne že lje nih dej sta va i ovi sku po-vi će bi ti akre di to va ni od stra ne Zdrav stve nog sa ve ta Sr bi je.

Vršac

15 - 16. novembra

2013. godine

Kongresno-muzička

dvorana Centra

Millennium AD

Vršac

111515 - 16. novembra

2013. godine

Kongresno-muzička

dvorana Centra

Millennium AD

Vrsac

15t�-16t� � ovember 2013

Congress and Music � all

o� t�e Centre Millennium AD

� ru�aci�a domaći�

�roizvođača lekova

Association of Local Manufacturers

of Medicinal Products

Agenci�a za lekove i

medicinska sredstva �rbi�e

Medicines and

Medical Devices Agency of Serbia

�od �okrovitel�stvom

Ministarstva zdravl�a �e�ublike � rbi�e

Under the Auspices of

Ministry of Health of the Republic of Serbia

uz �odršku

� družen�a �roizvođača

inovativni� lekova – �� � V�A

i � družen�a za una�ređivan�e

klinički� is�itivan�a - K��� ��

With support of

Association of the Manufacturers

of Innovative Drugs – INOVIA

and Association for Advancement

of Clinical Research of Serbia - KLINIS

9. tradicionalni simpozijum

9th Traditional Symposium

Programme

13:00-14:00 Lunch

Afternoon Session

14:00 -14:30 Assessment of the decisions:

International Health Technology Assessment networking

Caroline Laborde

14:30-15:10 Advertising surveillance, consumption surveillance

Georges Hazebroucq

15:10-15:25 Coffee break

15:25- 16:25 Concrete case: diabetes therapy

Caroline Laborde

16:25-17:00 Debriefing of D1-D2

Caroline Laborde and Georges Hazebroucq

Third day, 11th February 2009

The Serbian situation (current situation, prospective...)

Caroline Laborde and Georges Hazebroucq

10:00-10:10 Introduction- Georges Hazebroucq

10:10-10:25 ALIMS presentation-Danka Stefanovic

10:25-10:40 Ministry of Health

10:40-10:55 Serbian Institute of Health Insurance

10:55-11:15 Coffee break

11:15-14:00 Discussion and conclusions

14:00 Certificate issuing

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7. ALIMS PublicationsNRL and NRVLNational Registry of Medicines (NRL) and the National Register of veterinary medicines (NRVL) are guides to physicians and pharma-cists, or veterinarians who contain the phar-makoinformatical information necessary for prescribing and dispensing of medicines and other useful information for the implemen-tation of pharmaceutical care and providing pharmaceutical health services.

7. Pu bli ka ci je ALIMSNRL i NRVLNa ci o nal ni re gi stri le ko va (NRL) od no sno Na ci o nal ni re gi star ve te ri nar skih le ko va (NRVL) su pri ruč ni ci za fa r ma ce u te i le ka re, od no sno ve te ri na re ko ji sa dr že fa r ma ko in for-ma tič ke po dat ke neo p hod ne za pro pi si va nje i iz da va nje le ko va i dru ge ko ri sne in for ma ci-je za spr o vo đe nje fa r ma ce ut ske zdrav stve ne za šti te, od no sno za pru ža nje fa r ma ce ut skih zdrav stve nih uslu ga.

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Pro met i po tro šnja le ko vaU skla du sa Za ko nom o le ko vi ma medicinskim sredstvima, ALIMS pri ku plja i ob ra đu je po-da t ke o pro me tu i po tro šnji le ko va u Sr bi ji i pu bli ku je ih na go di šnjem ni vou. U ovim knji-ga ma se na la ze zdrav stve no-eko nom ski i sta ti stič ki po ka za te lji kao i fa r ma ko-epi de mi-o lo ški po ka za te lji upo tre be le ko va iz ko jih se mo gu iz vo di ti ana li ze a sve sa ci ljem da bu-du od ko ri sti dr žav nim in sti tu ci ja ma ali i svim uče sni ci ma u pro me tu le ko va u Sr bi ji.

Fa r ma ko te ra pij ski vo dičFa r ma ko te ra pij ski vo dič je pu bli ka ci ja ko ja sa dr ži in for ma ci je o pro fi li ma le ko va, or ga ni-zo va na u skla du sa ATC kla si fi ka ci jom o me-di cin skim pro iz vo di ma sa broj nim fa r ma ko in-for ma tič kim po da ci ma u ve zi sa bez bed nom pri me nom le ko va.

Osta le pu bli ka ci jeAgen ci ja je ob ja vi la ili po dr ža la ob ja vlji va nje ve li kog bro ja struč nih pu bli ka ci ja, me đu ko ji-ma tre ba iz dvo ji ti Ma gi stral ne fo r mu le (2008).

Marketing and consumption of medicinesIn accordance with the Law on Medicines and medical devices, ALIMS collects and pro-cesses data on marketing and consumption of medicines in Serbia and publishes them annually. In these books, there are health-economic and statistical indicators, as well as pharmaco-epidemiological indicators of medicines use from which the analysis can be developed with the goal of being used by state institutions and all participants in the medicines market in Serbia.

Pharmacotherapy GuidePharmacotherapy Guide is a publication which contains information on the profiles of medicines, organized according to the ATC classification of medical devices with numer-ous pharmakoinformatical data related to the safe use of medicines.

Other publicationsAgency published or supported the publica-tion of a large number of expert publications, among which Magisterial formulas (2008) should be pointed out.

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8. ALIMS Website

Agency’s website (www.alims.gov.rs) allows the Agency to achieve transparency in its work and in a simple way make available all rele-vant information about the work and achieve-ments of the Agency for health care workers, patients and the pharmaceutical industry. The most important features on the website include: Search option for the medicines, medical devices, veterinary medicines and clinical trials, as well as Search of the series certificates.On the website, the Agency clients are notified of any procedures that are performed in the Agency and legislation relating to procedures from the scope of the Agency, and finally, they can check the status of their request.The notifications and statements from the Agency to the Marketing Authorization hold-ers, professional and general public are pub-lished on the website, and this web page includes customer service and through that questions to the Agency can be asked.Finally, through the Agency’s website ad-verse reactions on human and veterinary medicines, as well as adverse reactions to medical devices can be reported, including the “online” application.

8. In ter net stra ni ca ALIMSIn ter net stra ni ca Agen ci je (www.alims.gov.rs) omo gu ća va Agen ci ji da po stig ne tran spa rent-nost u ra du i da na jed no sta van na čin uči ni do stup nim sve re le vant ne in for ma ci je o ra du i re zul ta ti ma ra da Agen ci je za zdrav stve ne rad ni ke, pa ci jen te i fa r ma ce ut sku in du stri ju.Naj zna čaj ni je op ci je na In ter net stra ni ci su: pre tra ži va nje le ko va, me di cin skih sred sta va, ve te ri nar skih le ko va i kli nič kih is pi ti va nja, kao i pre tra ži va nje se r ti fi ka ta odobrenih se ri ja.Na In ter net stra ni ci se kli jen ti Agen ci je mo-gu oba ve sti ti o svim pro ce du ra ma ko je se spr o vo de u Age ni ci kao i za kon skoj re gu-la ti vi ko ja se od no si na po slo ve iz de lo kru-ga Agen ci je i naj zad, pro ve ri ti sta nje svog zah te va.Na In ter net stra ni ci se pu bli ku ju i oba ve šte-nja i sa op šte nja Agen ci je za no si o ce do zvo la, struč nu i op štu jav nost, sta ni ca sa dr ži i ko ri-snič ki se r vis a pre ko nje se mo gu i po sta vi ti pi ta nja Agen ci ji.Konačno, preko Internet stranice Agencije se može prijaviti neželjena reakcija na humani i veterinarski lek, kao i neželjena reakcija na medicinsko sredstvo, uključujući i „online“ prijavu.

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Agencija za lekove i medicinska sredstva Srbije - ALIMSVojvode Stepe 458, 11221 Beograd, Srbijawww.alims.gov.rsi-mejl: hygia@alims.gov.rs

DirektorSpec. dr. med. Saša Jaćović

UrednikMag. farm. Pavle Zelić

IzdavačHelicon Publishing, Pančevo

Za izdavačaVelimir Živković

ŠtampaHelicon Publishing, Pančevo

Tiraž500

Medicines and Medical Devices Agency of Serbia - ALIMS

458, Vojvode Stepe Street, Belgrade 11221, Serbia

www.alims.gov.rse-mail: hygia@alims.gov.rs

Managing Director Sasa Jacovic, M.D., sp.

EditorPavle Zelic, Phar.M.

PublisherHelicon Publishing, Pancevo

On behalf of PublisherMr. Velimir Zivkovic

ProductionHelicon Publishing, Pancevo

Printing500