pharmacy law and regulations 2014

Pharmacy Law and Regulatory

Affairs

As part of Orientation to Pharmacy and pharmacy Law Course

(0200131)

September, 2014

Instructor

Khairi Mustafa Salem. B.Pharm, PhD.

Orientation to Pharmacy and Pharmacy Law (0200131)

Table of Contents:

No. Title Page Number

1Chapter 1: Pharmacy law and Regulatory Affairs,

MOH, UAE 3

2UAE Federal Law No: 4, 1983: The Pharmaceutical

Professions and Institutions 4

3Guidelines and Minimum Standards for Good Pharmacy Practice (GPP) in UAE Pharmacies

33

4 Code of Professional Conduct 40

5Pharmacist Job Degrees in Ministry of Health in

United Arab Emirates46

6Appendix A: Controlled, Semi-Controlled and

Narcotic Medicines (2007-2008) 1-49

7Chapter 2: Policies and Regulatory Affairs, Health

Authority of Abu Dhabi (HAAD), UAE 47

8Pharmacy Profession: Personal Qualification

Requirement48

9 Generic Drugs Policy 50

10Policy on the Expiry Date of Medicines, Medical Consumables and Chemicals in Public Pharmacy

64

15Appendix B: A Guide to the Management of

Controlled Drugs in the Private Sector1-29


Chapter 1:

Pharmacy law and Regulatory

Affairs, MOH, UAE

UAE FEDERAL LAW NO: 4, 1983Orientation to Pharmacy and Pharmacy Law (0200131)

The Pharmaceutical Professions and Institutions

Contents

1 Definitions (Article 1)

2 Pharmacists and Assistants (Articles 2-5)

3 The License Committee (Articles 6-9)

4 Temporary Licenses (Article 10)

5 Prescriptions (Articles 11-15)

6 Pharmacist Duties (Articles 16-18)

7 Licensing of Pharmacies (Articles 19-33)

8 Licensing of Drug Stores and Ad Hoc Provisions (Articles 34-46)

9 Licensing of Medicines Factories and Ad Hoc Provisions (Articles 47-58)

10 Licensing of Scientific Offices and Ad Hoc Provisions (Articles 59-62)

11 Registration of Medicines, Companies and Pricing (Articles 63-67)

12 Poisons and Dangerous Drugs (Articles 68-76)

13 Inspectors Authority (Article 77)

14 Disciplinary Powers and Fees (Articles 78-94)

Federal Law No: 4 of 1983 on Pharmaceutical Profession and Institutions:

We, Zayed Bin Sultan Al Nahyan, President of the United Arab Emirates:

After taking cognisance of the provisional constitution; Federal Low No: 1 of

1972 and the laws amending it on jurisdictions of Ministries and powers of

Ministers; Federal Law No: 5 of 1974 on practicing pharmaceutical profession

and trading in a medicine; And in accordance with what has been submitted by

Minister of Health, approved by the Cabinet and Federal National Council and

endorsed by the Federal Supreme Council; Have issued the following:


ARTICLE 1

In the application of the provisions of this law, the following words and phrases

shall have the meanings stated herein:

1 The Country The United Arab Emirates

2 The Minister The Minister of Health

3 The Ministry The Ministry of Health

4 Pharmaceutical Profession Preparation, composition, separation,

manufacturing, bottling or packing,

selling or distribution of any medicine for

protection or treatment of human beings

or animals.

5 The Pharmacist Any person holder of pharmacy

certificate from a recognised high

institute, college or university.

6 Licensing Committee The Committee stated in the article 6 of

this law.

7 Licensed Pharmacist Any person licensed to pharmaceutical

profession according to the provisions of

this law.

8 The Pharmaceutical Institution Public or private, pharmacy, medicine

factories and stores and scientific offices.

9 Medicine Any medicine that contains one or more

element for treatment or protection of

human beings and animals.

10 Chemical Elements Basic elements composing the medicine

11 Medical Appliances Equipment other than medicine and

which are used for medical purposes.


12 Medical Store Any institution inside the country for

import, storage and distribution of

medicine (wholesale).

13 Medical Factory The production unit inside the country

and which manufactures medicine.

14 Scientific offices The scientific centres that notify and give

information about medicine and chemical

elements produced by factories, which

the scientific offices affiliate.

ARTICLE 2

No person is permitted to practice pharmaceutical profession without obtaining

a licence according to the provisions of this law.

Persons who apply to obtain the licence should:

1 Hold a pharmacy certificate from a recognised high institute, college or

university.

2 Practiced pharmaceutical profession for a period not less than two years (for

foreigners)

3 Have a clear police record.

4 Fluent Arabic and foreign language.

5 Pass the examination to be organised by the Ministry in this regard and

according to the rules to be issued by the Minster in consultation with the

licensing committee.

ARTICLE 3


No person should practice the profession of assistant pharmacist without

obtaining the licence according to the provisions of this law.

To obtain the said licence the applicant should be:

1 Holder of a recognised assistant pharmacist certificate.

2 Practiced the profession for at least two years in one of the pharmaceutical

institution under the supervision of a licensed pharmacist.

3 Have a clear police record.

4 Fluent in Arabic and one of the foreign languages.

5 Pass the examination to be conducted by the Ministry for this purpose and

according to the rules to be issued by the Minster after consultation with

licensing committee.

ARTICLE 4

The documents to be attached to the application for obtaining the licence stated

in article 2 and 3 shall be determined by the decision to issue by the Minister.

ARTICLE 5

The licensed pharmacist may appoint as an aide an assistant pharmacist who

fulfilled the conditions stated in the article 3 of this law.

He may also appoint with him in the pharmaceutical institution students from

Pharmacy College or assistant pharmacists who did not completed the training

period after obtaining the Ministry’s approval and shall be responsible for the

mistakes they may commit.

ARTICLE 6

A committee to be named the licences committee shall be set up in the Ministry.Orientation to Pharmacy and Pharmacy Law (0200131)

The formation of this committee and its work regulations shall be determined by

a decision to be issued by the Minister.

The licences committee shall look into the application for obtaining the licences

stated in article 2,3,18,34,47 and 60 of this law (licensing pharmacists and

assistant pharmacist and opening pharmacy, drug store, medicine factory or

scientific office).

The committee shall submit its recommendations in this concern to the Minister

for action.

ARTICLE 7

The licence committee shall practices its duties stated in the article 6

considering that priority for obtaining licences shall be for UAE nationals, Arab

nationals and then other nationalities.

ARTICLE 8

The committee should state the reasons for rejecting the application and the

applicant may submit to the Minister his complaint on the committee’s decision

within a period of 30 days from the date of his notification about the decision

rejecting the licence. The minister’s decision in this concern shall be final.

ARTICLE 9

A record including the pharmacists and assistant pharmacists licensed to

practice the pharmaceutical profession according to the provisions of this law

shall be set up in the Ministry.

The Minister shall issue a decision determining the form of the record and the

information and statements, which should be included.

ARTICLE 10Orientation to Pharmacy and Pharmacy Law (0200131)

Pharmacists and assistant pharmacists employed by the government authorities

shall be granted by a decision to be issued by undersecretary of the Ministry

temporary licence to work only with the employer.

ARTICLE 11

The licensed pharmacist should not give any medicine or medicinal preparation

without a medical prescription in a clear hand-writing carrying the name of the

licensed doctor who issued it, its stamp and date issue. If the prescription

included one of the drugs stated in one of the tables appended to this law, the

licensed pharmacist should make sure of the following before giving the drug:

1 That the medical prescription is numbered and stamped by the Ministry’s

stamp and issued in the form prepared for this purpose.

2 Written in an ineffaceable (impossible to remove) material.

3 The prescription should include the amount of medicine in letters and figures,

directions and name and address the patient.

4 Should not be issued for a period exceeding two days.

5 The prescribed dose should not be more than what has been stated in the

pharmacopoeia and the period of usage not to exceed three days.

The provisions of the paragraph 1 of this article shall not apply on what is sold

by a pharmacy to another or to a medical institution.

Duration of prescription allowed for CDA and CDB drugs depends on the status of the prescriber

Prescriber status

Duration of prescripti

General Practitioner 3 days

Specialist 2 weeks


Consultant 4 weeks

Psychiatry Specialist 4 weeks or Consultant

ARTICLE 12

Licensed pharmacist is not permitted to grant, dispense of sell poisons on

amounts in excess of the doses laid down in the pharmacopoeia.

ARTICLE 13

Licensed pharmacist is not allowed to make any changes in the medical

prescription before consulting the doctor who issued the prescription.

He is also not permitted before obtaining the approval of the doctor, to repeat

the supply of tranquillisers or medicine including abortifacients (substances that

induces abortion) or, a medicine, which may lead to addiction.

ARTICLE 14

If the licensed pharmacist discovered a mistake or omission in the medical

prescription or become doubtful about part of it, he should discreetly contact the

doctor who issued the prescription and he may return the prescription to the

doctor if he rejected the clarification made by the doctor.

In this case, the doctor should underline the issue in dispute and sign it.

ARTICLE 16

The licensed pharmacist should carry out his duties in conformity with

regulations of the profession and in particular:

1 Shall not conduct any practices against the honour of the profession.

2 Shall keep confidential the disease, which he may come to know through the

medical prescription presented to him or through any means related to his

practicing of his work.Orientation to Pharmacy and Pharmacy Law (0200131)

3 Shall abide by the laws and regulations followed in this profession.

4 Shall notify the communicable diseases he may discover during practicing his

duties.

5 Should not undertake himself any work other than his work in the pharmacy.

ARTICLE 17

The licensed pharmacist should not commit any work in violation of the duties

of the profession in particular:

1 Encouragement of patients to buy medicine from his pharmacy through secret

deals with others.

2 Monopoly, hiding or selling of medicine for prices higher than the fixed prices

3 Change of medicine as regards quantity or quality in contradiction with the

provision stated in the law.

4 Selling of free medical samples.

5 Practicing medical or nursing works except for those relating to first aid and

in necessary cases.

6 Dispensing of medical prescription through a code or a signal not agreed upon scientifically. Dear Dr. Hani

Many thanks for your interest in the College of pharmacy, unfortunately no vacant academic posts in the medicinal chemistry at the current time; we will contact you in future for any related posts to your academic experience

Thanks again for your interest in CoP at Al-Ain University

Best Regards

Khairi Mustafa Salem. B.Pharm., PhD

Dean, Pharmacy College

Dear Dr. Hani




Best Regards



Dear Dr. Hani



Best Regards



7 Agreement with a doctor to write prescription in a special way or code

between them.

8 Criticizing or abusing the doctor whom issued the prescription before others.

ARTICLE 18

No person is permitted to open a pharmacy before obtaining a license according

to the provisions of this law.

ARTICLE 19

For opening a pharmacy the following should be fulfilled:

1 The applicant for the licence should be a UAE national.

2 A licensed pharmacist should manage the pharmacy.

3 The distance between the pharmacy and the nearest pharmacy should not be

less than 200 meters.


4 The pharmacy should fulfil the health and technical conditions to be

determined by the Minister.

ARTICLE 20

Applicant who wants to obtain a licence to open a pharmacy should submit his

application to the licences committee including the following:

1 Name, nationality and address of the applicant.

2 Number and date of issue of the licence for practicing the pharmaceutical

profession granted to the pharmacist who shall be responsible for the

management of the pharmacy.

3 The Minister shall determine the documents, which should be attached with

the application.

ARTICLE 21

The concerned administrative authorities in the Ministry shall examine the place

supposed to be occupied by the pharmacy to see whether all conditions stated in

the law are fulfilled. The said authorities shall submit a report on its work to the

licences committee.

ARTICLE 22

The licence for opening a pharmacy shall be personal and should not be

relinquished to others.

The licence shall be considered null and void by the power of law if the

ownership of the pharmacy is transferred to another person. In this case, a new

licence should be obtained.

In all cases the licences for opening a pharmacy shall be for one year renewable.

ARTICLE 23


Without obtaining the approval of the Ministry, the pharmacy should not be

shifted from one place to another and no change should be introduced in its

designs of planning.

ARTICLE 24

The name of the pharmacy should be written a big Arabic letters on a board to

be fixed in an easily visible place.

ARTICLE 25

The licence of the pharmacy shall be considered expired by the force of law in

the following cases:

1 The transfer of the ownership of the pharmacy to another

2 The closure of the pharmacy for six consecutive months without strong reason

accepted by the licences committee.

3 Failure to start work in the pharmacy within six months from obtaining the

licence.

ARTICLE 26

No person shall be licensed to operate more than one pharmacy. A pharmacist

who is a government employee is not permitted to open, manage or work in a

private pharmacy.

ARTICLE 27

In case of absence of the licensed pharmacist responsible for administration of

the pharmacy, another licensed pharmacist should be appointed to replace him.

The period of the annual absence should not exceed 60 days. An assistant

pharmacist who worked in the pharmacy for at least three months should be

present.


ARTICLE 28

The pharmacy should be reserved only for storing, preparing of medicine and

medical preparations, selling of cosmetic material, perfumes, children’s food,

medical milk, insecticides, medical surgery optical and laboratory equipment,

dental equipment, toothbrush and pastes and shaving soaps and similar items.

ARTICLE 29

No pharmacy should have an entrance leading to a clinic, shop, apartment or

any place, which has no relation with its activities.

ARTICLE 30

The urgent first aid equipment, basic medicine, other equipments, reference

books and official records which should be secured in the pharmacy shall be

determined by a decision to be issued by the Minister. The Minster shall also

issue a decision determining the banned medicines and ways of keeping and

circulation of tranquillisers and poisons.

ARTICLE 31

The medicines should be kept in the pharmacy in a good condition and

according to the technical conditions. Medicines whose date is expired should

not be kept in the pharmacy.

ARTICLE 32

The Ministry shall organize the night and morning shifts of the pharmacies.

ARTICLE 33


Licence may be granted for opening of pharmacies for a government body,

public authority, public institution, society or private hospitals on condition that

these pharmacies are under the management of a full-time licensed pharmacist

and serve only the party, which may affiliate.

The conditions for opening such pharmacy shall be determined by a decision to

be issued by the Minister.

ARTICLE 34

Before obtaining a licence according to the provisions of this law, no person is

permitted to open a medical store.

ARTICLE 35

The following conditions should be fulfilled before opening of a medical store:

1 The applicant to obtain the licence should be a UAE national.

2 A licensed pharmacist should run the store’s management.

3 The store should fulfil the medical and technical conditions to be determined

by the Minister.

ARTICLE 36

Applicant, for obtaining a licence for a medical store should submit to the

licences committee an application including the following:

1 Name nationality, age and address of the applicant.

2 Number and date of the licence issued to the pharmacist charged with

conducting the management of the store.

3 The documents which should be attached to the application (the documents

shall be determined by the Minister).

ARTICLE 37Orientation to Pharmacy and Pharmacy Law (0200131)

The place to be selected for the premises of a medical store shall be examined

according to what has been stated in article 21 of this law.

ARTICLE 38

The licence to open a medical store shall be personal, not to be relinquished to

others. The licence shall be considered null and void by the force of law if the

ownership of the store was transferred to another person.

In all cases, the licence of the store shall be for one year renewable.

ARTICLE 39

A record shall be established in the Ministry to include names of the owners of

licensed stores. The Minister shall issue a decision determining the form of the

record, the information to be included and the administrative authority, which

shall supervise and organize the record.

ARTICLE 40

No person is permitted to import medicines, chemicals or medicinal

preparations unless he is owner of medical store and obtained a licence for

import of the said items according to the provisions of the law.

ARTICLE 41

If the owner of the medical store is an agent for the party that produces the

medicine, medicinal preparations or chemicals, he shall not be granted the

importation licence except from the same party.

ARTICLE 42


Owner of medical store should keep a general record to include incoming

medicines, pharmaceutical preparations and chemicals, date of their supply and

the daily amounts dispensed.

He should also keep a special record for poisons, dangerous medicines and

psychiatric drugs.

The two records shall be kept by the pharmacist-responsible for the

management of the store.

ARTICLE 43

The owner of the store or the pharmacist responsible for its administration is not

permitted to sell or grant as a sample to any pharmacy a medicine or medicinal

preparation not priced or which has expired.

Any of them are also not permitted to enter into a deal with doctors or

pharmacist to pursue personal interests in contradiction with the provisions of

the law.

ARTICLE 44

The owner of the store or the pharmacist responsible for its administration are

not permitted to sell to a pharmaceutical, medical or treatment institution any

medicine to any person other than those licensed by the concerned authorities.

Chemicals used in industrial or agricultural purpose are also not to be sold to

persons other than those licensed by the authorities.

The provisions of article 28 of this law shall apply on the medical store.

ARTICLE 45

Owner of the store or the responsible pharmacist is not permitted to sell,

dispense or handover poisons in excess of the dose laid down in the

pharmacopoeia.


Licensed pharmacist responsible for the administration of a pharmacy, a doctor

licensed according to the provision of law or a person permitted to use poisons

material in his profession are exempted from the provision of the above

paragraph.

The number and price of any medicine or medical preparation should be written

on the cover.

ARTICLE 46

Owner of the store and the pharmacist responsible for its management should

abide by the provisions of laws and regulations on import, storing and

distribution of medicines.

ARTICLE 47

No person is permitted to open medical factory before obtaining a licence

according to the provisions of this law.

ARTICLE 48

Without prejudice (contradiction) to the provisions of federal law No: 1 of 1979

on organisation of Industry affairs, the following should be fulfilled for

obtaining a licence for medicine factory.

1 The factory should include production section, chemical, disinfection and

bacteriological laboratories and should fulfil the technical and medical

conditions to be determined by the Minister.

2 The supervision of the factory with all its sections and laboratories should be

by a manager licensed to practice pharmaceutical profession according to the

provisions of this law.

3 Every laboratory should be supervised by licensed pharmacists and specialists

in the medicines produced by the factory.


ARTICLE 49

To obtain a licence for opening a medical factory, an application should be

submitted to the licences committee including:

1 The contract for establishing the factory or its articles of association including

names of shareholders in its capital.

2 Number and date of the licence issued to manager of the factory to practice

pharmaceutical profession and licences issued to pharmacists.

3 Other documents determined by the minister.

ARTICLE 50

The site and premises of the factory should be examined according to what has

been stated in article 21 of this law.

ARTICLE 51

Manager of the factory shall be responsible for dangerous drugs and keeping

their records.

ARTICLE 52

In case of absence of manager of the factory for a certain period another person

licensed to practice the pharmaceutical profession should replace him.

And in the case of the manager who resigns, or is dismissed, a successor should

be appointed within 15 day from the date of the previous manager leaving the

work.

ARTICLE 53


The Ministry should be notified about the absence of the manager and the one

who replaced him.

The Ministry should also be notified names of staff of the factory and those who

are licensed to practice pharmaceutical profession and any change, which may

occur in their status.

ARTICLE 54

The type of records to be kept by the factory, their organization and the party

authorised to inspect these records shall be determined by a decision to be

issued by the Minister with taking into account the following:

1 The records should be stamped by the Ministry stamp, numbered and kept

with the manager responsible for the factory and its laboratories.

2 All required information should be registered in these records daily.

3 The records should include all transactions concluded in the factory mainly

the raw materials, their preparation manufacturing and distribution.

ARTICLE 55

The following stores should be attached to every medical factory:

1 Store for raw materials

2 Store for dangerous materials

3 Store for the manufactured preparations.

ARTICLE 56

The following preparations should be maintained in medical factories:

1 The buildings should be separated from each other and provided with all

safety measures.

2 All sections should include emergency exits.


3 The wastes should be disposed of in a way not to lead to environmental

pollution and not threaten general health.

4 All technical and health conditions should be maintained to secure the safety

of its staff.

ARTICLE 57

The provisions of articles from 33 to 45 of this law shall apply on stores of

medical factories.

ARTICLE 58

The licence for medical factory shall be considered by the force of law if the

share of the UAE national in its capital dropped to less than the percentage

stated in law No. 1 of 1979 on organisation of Industry affairs.

ARTICLE 59

No person is permitted to open a scientific office before obtaining a licence

according to the conditions to be determined by the Minister.

ARTICLE 60

For obtaining a licence for scientific office, the application should be submitted

to the licences committee.

ARTICLE 61


Scientific offices should not import medicines or pharmaceutical preparations or

store them for selling or advertising unless these offices are registered in the

Ministry according to the provisions of this law.

ARTICLE 62

The scientific offices should keep samples of medicines and pharmaceutical

preparations, which they want to advertise for.

The offices should also keep a record for their samples stamped with the

Ministry’s stamp and stating on every sample “not for sale” or an equivalent

phrase.

ARTICLE 63

A committee to be named medicines pricing and companies committee shall be

established in the Ministry to register the medicine and pharmaceutical

companies and fix the prices of medicines.

The Minister shall issue the decision on the formation to the committee and

regulation of its work.

The committee shall submit its recommendations on its work to the Minister for

action.

ARTICLE 64

The Minister may at the recommendation of the committee stated in article 63

decide the following:

1 Approve the registration of any medical company or any medicine or

pharmaceutical preparation proved suitable for circulation.

2 Ban the circulation of any medicine or pharmaceutical preparation proved at

any time harmful to public health.


In such cases, the medicine or pharmaceutical preparation should be cancelled

from the Ministry’s records if registered and all the amounts should be

confiscated and destroyed without maintaining any right to the owners to

contact the Minister for compensation.

3 Fixation of the price of any medicine or pharmaceutical preparation and

consider the pricing.

ARTICLE 65

No import medicine, pharmaceutical preparation or children’s food should be

put for circulation before being registered in the Ministry.

Any medical company, which plans the marketing of its production in the

country, should be registered in the Ministry.

ARTICLE 66

Any medicine or pharmaceutical preparation that undergoes a change to its

constituents should be re-registered.

ARTICLE 67

The following information and data should be written in Arabic and English in

the inside and outside leaflet and container of a medicine or pharmaceutical

preparation.

1 Name of medicine or pharmaceutical preparation and number of registration

in the Ministry.

2 Compounds of medicine and their amounts.

3 Date of expiry.

4 Name of the factory producing the medicine or pharmaceutical preparation.

5 Directions of use and cautionary warnings.


ARTICLE 68

The Minister shall issue the necessary orders to protect people from harms of

poisons and dangerous drugs.

ARTICLE 69

The following categories may possess dangerous drugs in the places where they

practice their profession and through the following means:

1 The pharmacist responsible for the management of the store and through

importation or purchase from another store.

2 The pharmacist responsible for the management of a pharmacy through

purchase from medicines store or a pharmacy.

3 The licensed doctor for use in purposes relating to his profession.

4 Curative institutions according to a special licence

5 Medical factories through importation and purchasing according to the

provisions of this law.

ARTICLE 70

The licensed pharmacist responsible for the management of a pharmacy may

dispense dangerous medicines for medical purposes only in one of the following

cases.

1 For patients who carry a medical prescription issued by a licensed doctor.

2 Owners of animals who carry diseases and who obtain a medical prescription

issued by licensed veterinarian.

3 Doctors according to a signed application certifying that the amount, which

they require, is for use in their clinics.


ARTICLE 71

Medical store or factory is not permitted to import dangerous drugs without

submitting an application signed by the licensed pharmacist or director of the

factory. The application should include all details relating to dangerous drugs to

be imported such as the amounts, type, loading methods, clearance station, the

exporting party and its address.

The importation shall be after obtaining the approval of the administrative party

to be named by the Minister.

ARTICLE 72

The medical prescription issued by the licensed doctor may include some

dangerous compounds of a medicine or a pharmaceutical preparation. The

Minister shall issue the decision determining these medicines.

ARTICLE 73

The licensed pharmacist responsible for the pharmacy or the medicines store

should keep a special record for dangerous medicines.

The pages must be clearly numbered and sequential according to the official

ministry format.

The pages should include detailed statement about the amount of dangerous

drugs purchased or imported, name of its supplier or exporter, date of delivery

or arrival, the amounts dispensed or sold, name and address of the patient or the

buyer.

ARTICLE 74

The licensed pharmacist responsible for the management of the pharmacy or

medicines store should keep all medical prescription for dangerous medicines

dispensed or sold for at least five years from the date of selling or dispensation.Orientation to Pharmacy and Pharmacy Law (0200131)

ARTICLE 75

The licensed pharmacist responsible for the management of the pharmacy or

medicines store should conduct a regular inventory (check-ups) to examine that

what is stated in the dangerous medicines record is in conformity with what is

actually found.

If any differences are discovered he should inform the Ministry to take the

necessary measures.

ARTICLE 76

Without prejudice (contradiction) to the provisions of the International

agreements which the country ratified (approved), the Minister may add to the

tables No.1, 2 and 3 appended to this law, any medicines or pharmaceutical

drugs proved as poisonous or dangerous.

The Minister may also drop from the said tables any medicines or

pharmaceutical preparations proved not poisonous or dangerous.

The Minister’s decision in this regard shall be published in the official gazette

and enter into force as from the date of its issue.

ARTICLE 77

The Minister of Justice, Islamic Affairs and Awkaf shall after consultation with

Health Minister, issue a decision determining the person who shall have the

legal authorization for inspection of pharmaceutical institutions.

Owners of the pharmaceutical institution should cooperate with officials in their

work.

The appointed inspectors may inspect any pharmaceutical institution to check

whether it is dealing in medicines and poisons trade with obtaining a licence.

ARTICLE 78


The licences committee shall look into the cases committed by licensed

pharmacists and owners of the pharmaceutical institutions in violation of the

provisions of this law and its executive rules and regulations.

The committee should notify the violator to stand before it at least three days

before the date fixed for the session.

If the violator failed to appear before the committee on the fixed date the

committee may take its decision in his absence.

ARTICLE 79

The licence committee may impose one of the following disciplinary

punishments on the violating licensed pharmacist:

A. Warning

B. Suspension for a period not to exceed one year.

C. Withdrawal of the licence.

The committee may impose on owner of the pharmaceutical institution one of

the following:

D. Warning.

E. Closure of the institution for a period not exceeding 60 days.

If the violation is repeated, the institution may be closed for period not

exceeding six months in total in the same year. The committee may also

withdraw the licence.

The punishments stated in this article should be taken only after hearing the

violator’s defiance. If he failed to appear before the committee, it may take its

decision according to the documents before it.

The committee shall issue its decisions to the Minister for approval.

ARTICLE 80


Appeals and complaints against the committee’s decision may be submitted to

the Minister within 15 days from receiving the decision.

The Minister’s decision in the appeal shall be issued within 30 days from the

date of its submission and his decision in this concern shall be final.

In all cases the decision on suspension, withdrawal of the licence of the

pharmacist or closure of the pharmaceutical institution should not be

implemented before the expiry of the date fixed for the appeal.

ARTICLE 81

If the licences committee found that the continuation of the pharmaceutical

institution in practicing its work will lead to harmful results, it may decide the

institution be closed pending (awaiting) final decision.

The precautionary closure shall be approved by the Undersecretary (senior

administrator usually second-in-command) of the Ministry and shall be

implemented as from the date of its approval.

ARTICLE 82

The disciplinary decision taken according to the provisions of this law shall not

nullify the criminal responsibility resulting from the same violation.

ARTICLE 83

Without prejudice to any other harsher punishment decided by other law,

imprisonment for a period not less than 6 months and not to exceed one year, a

fine not less than Dh. 1,000 and not to exceed Dh. 5,000 or one of the two

punishments shall be imposed on the person who:

1 Present false documents or wrong statements or followed illegal channels to

obtain a licence in violation of the provisions of this law.

2 Practiced the pharmaceutical profession without fulfilling the conditions

stated in this law.


ARTICLE 84

Without violation of harsher punishment stated by other law, imprisonment not

less than six months and not to exceed one year, a fine not less than Dh. 1,000

and not exceed Dh. 3,000 or one of the two punishments shall be imposed in the

following cases:

1 The pharmacist who fulfils the conditions stated in this law to practice

pharmaceutical profession but practiced the profession before obtaining the

licence.

2 Any pharmacist who violate the provisions of article 13 or 16 of this law.

ARTICLE 85

Without prejudice to any harsher punishment stated in other laws, any person

who violates the prices fixed for medicines and pharmaceutical preparations

shall be fined not less than Dh. 1,000 and not more than Dh. 5,000

If he repeated the violation and a final conviction decision was taken, the

licence granted to him shall be considered withdrawn by the force of law.

ARTICLE 86

Without prejudice to any harsher punishment sated in other laws, any person

who forge (counterfeit) or fraud a medicine, pharmaceutical preparation or

chemicals shall be sentenced to imprisonment for a period not less than one year

and not to exceed three years, a fine not less than Dh. 2,000 and not to exceed

Dh. 10,000 or one of the two punishments.

Beside the punishments stated in article 83 and 84 and the first paragraph of this

article, the court may order the withdrawal of the licence.


ARTICLE 87

Any violator of the provisions of this law or its executive regulations and which

are not included in one of the rules stated in article 83, 84, 85 and 86 of this law,

shall be fined not less than Dh. 1,000 and not more than Dh. 5,000.

ARTICLE 88

In the case of the withdrawal of the licence in accordance with the provisions of

article 83 of this law or a final decision was taken on withdrawal of the licence

in accordance with articles 81, 82 and 84 of this law, the Minister may permit

the appointment of another pharmacist to undertake the management of the

pharmacy or the store.

He may also decide to final closure of the pharmacy or the store and after its

liquidation of till assets and selling it under the supervision of the Ministry.

ARTICLE 89

The Ministry may collect fees for the licences and registrations made according

to the provisions of this law on conditions that the fees collected not to exceed

Dh. 10,000 for the factory licence and Dh. 2,000 for other licences and records.

The Minister shall at the recommendation of the licences committee of the issue

a decision determining these fees.

ARTICLE 90

The obtaining of the licence stated in this law shall not exempt from obtaining

other licences decided by existing laws and regulations.

ARTICLE 91


If the agent of a medicine or pharmaceutical preparation is changed, the new

agent should notify the Ministry about the change within 30 days from the date

of transfer of the agency to him.

ARTICLE 92

Publication of pamphlets (brochures) or books and advertising through

newspapers, radio and TV for any medicine, pharmaceutical preparation, or

children’s food to be determined by the Minister shall not be permitted (without

approval).

ARTICLE 93

Except for the distance condition stated in article 19 (200 meters) of this law, all

existing pharmaceutical institutions should correct their situation according to

the provisions of this law within six months from the date when this law enter

into force.

ARTICLE 94

Police staff shall assist in implementing the final disciplinary decisions on

closing pharmaceutical institution according to the provisions of this law.

ARTICLE 95

The Minister shall issue the executive decisions for implementation of this law.

ARTICLE 96

Law No.5 of 1974 and provisions, which contradict the provisions of this law,

shall be considered null and void.


ARTICLE 97

This law shall be published in the official gazette and enter into force 30 days

from the date of its publishing.

Guidelines and Minimum Standards for Good Pharmacy

Practice (GPP) in UAE Pharmacies

July, 2003

Introduction:

There are almost 1000 pharmacies across the UAE and they are staffed by

pharmacists and assistants from over 20 countries. Minimum standards of


practice vary across the globe for all professions and pharmacy is no exception.

The people of the UAE have access to a high standard of medical care and this

has been applauded (admired) by the World Health Organisation. The WHO,

together with the International Pharmacy Federation (FIP) have published Good

Pharmacy Practice guidelines and have called for all countries to develop

minimum standards of pharmacy practice. This document is the first step to

stating publicly what the minimum requirements are for Good Pharmacy

Practice.

These guidelines and standards are used as the basis for inspection by Ministry

of Health inspectors.

1. Legal and Ethical framework

1.1. Pharmacy law and code of practice: pharmacists and assistant pharmacists

must comply with the UAE Pharmacy law (No.4 for 1983) and the

Ministry of Health (MOH) Code of Conduct for Pharmacists. Copies of

these should be available in the pharmacy.

1.2. Continuing professional development is essential and pharmacists and

assistants must keep their knowledge and skills up to date. A record of

professional development activities should be maintained.

2. Personnel

2.1. The list of staff on duty must agree with that registered at the MOH.

Students can only be trained after MOH approval.

2.2. Assistants and any unlicensed staff, including pharmacists or students,

must be under the supervision of a licensed pharmacist when dispensing

medicines.

2.3. All staff must wear clean, white coats


2.4. All staff must wear a name badge stating their name, position and license

number.

2.5. The staff must project a clean, tidy & professional appearance.

3. Environment and Equipment

3.1. The pharmacy must be structurally unchanged from when the license was

last issued or renewed. Any structural changes must be approved by the

ministry.

3.2. The pharmacy must be clean and tidy. Floors, walls and ceiling must be in

good repair. Shelves must be neat and logically arranged with no visible

dust.

3.3. Air conditioning must be working efficiently and a thermometer should be

used to record the temperature in the pharmacy. Records must be kept to

show that the temperature does not exceed 30°C at any point during the

day or night.

3.4. Lighting must be strong and well maintained throughout the pharmacy,

especially in any dedicated dispensing areas.

3.5. Electrical wires must not present a danger for staff or customers e.g. must

not trail across the floor.

3.6. Work surfaces should be impervious, clean and well maintained

3.7. Running water must be available for washing, cleaning and preparation of

medicines. Drainage must be adequate.

3.8. A medicines refrigerator must be available for storage of any medicines

that require refrigeration. The temperature must be monitored and

recorded to demonstrate that it remains between 2 and 8°C at all times.


3.9. All pharmacies should have a computer that can be used for record

keeping and correspondence. Electronic-point-of-sale (EPOS) systems,

computerised stock control and ordering systems are strongly

encouraged. Where possible these systems should support the

production of typed labels for dispensed medicines.

3.10. Internet access and email access from the pharmacy is strongly

recommended.

3.11. All pharmacies must have a working telephone line. A fax machine is

recommended.

3.12. The pharmacy must enforce a strict “No smoking” policy within the

pharmacy.

3.13. The pharmacist is responsible for the security of the medicines.

Precautions must be in place to minimise the risk of a person stealing

medicines.

3.14. Fire prevention and fire fighting equipment must be working and in

accordance with the civil defence requirements.

3.15. Pest control must be in place to prevent and eliminate infestations and

should be in accordance with municipality requirements.

3.16. Pharmaceutical waste must be disposed of in accordance with UAE laws

and regulations. It must not be disposed of via the routine garbage

collection system. Disposal of pharmaceutical waste via the approved

companies must be recorded and these records must be available see

also 5.11 below.

4. Documents

4.1. Pharmacy license and the in-charge pharmacist's license must be available

and on display to the public.


4.2. All pharmacies must display their opening hours to the public and the

contact details for late-night pharmacies and local hospital emergency

departments.

4.3. Each pharmacy must keep a file of MOH circulars or have access to the

MOH drug control web-page.

4.4. The register requirements for controlled drugs must be followed. These

are summarised below. More information and advice is available direct

from the inspection section. The pharmacist in charge shall record the

data and description of the controlled medicines dispensed daily as

follows:

4.4.1. Psychotropic drugs register (also known as the “Registered

Prescription”, R.P, “group 4” medicines or “CD-A”). The register is

obtained from the Ministry of Health after payment of the specified

fees, and it shall be labelled “CD-A” / "R.P" / Group 4.

4.4.2. Semi-Controlled drugs register, also known as “Controlled

Prescription”, C.P, or “group 5” medicines. For each item, the register

should record the date and quantity dispensed. It must be labelled

“CD-B” / "C.P” / Group 5.

4.5. Prescription file system

In addition to the controlled drugs registers, the following files shall be

kept and presented to the inspector on request:

4.5.1. General file, to be divided into two parts:

• First part, the reports and circulars issued by Ministry of Health

(unless there is access to these via the internet).


• Second part, Copies of staff licences, MOH approval of staff leave &

training positions, pharmacy operating procedures etc.

4.5.2. Price file: For filing the MOH price list and updates (electronic

version is acceptable).

4.5.3. Controlled medicines prescriptions, to be divided as follows:

• First part: “CD-A” / “RP” / group 4 prescriptions, arranged by

prescribing doctor and date.

• Second part: “CD-B” / “CP” / group 5 prescriptions, arranged by

prescribing doctor and date.

4.6. Delivery notes for controlled medicines must be filed (according to agent)

and kept for at least 12 months after delivery. Controlled medicine

prescriptions must be kept for 5 years from the date of dispensing

(Minimum of 2 years in the pharmacy, remaining 3 years can be in

secure storage). Computerised records may be acceptable after careful

consideration by the Ministry of Health inspection section.

4.7. All pharmacists must have access to at least one international

pharmacopoeia such as Martindale: The complete drug reference. An

electronic subscription is acceptable. The latest editions should be

available and must not be more than one edition out of date.

5. Dispensary

5.1. Medicines and healthcare products must be approved for sale in the UAE

by the MOH.

5.2. Prescription medicines should not be included in pharmacy-window

displays or otherwise advertised to the public.


5.3. Prescription medicines must not be available for self-selection by the

customers.

5.4. All medicines must be clearly marked with the latest MOH approved

retail price.

5.5. Medicines must be sold as original packs. If part packs are required then

they must carry the medicine name, batch number and expiry date and

the patient must receive (free of charge) a copy of the original package

insert or patient leaflet from the pharmacy.

5.6. Controlled medicines must be stored in a lockable cupboard

5.7. Prescriptions for controlled items should only be dispensed if they are

valid according to UAE law number 4 (article11) and regulations.

5.8. Prescription medicines can only be sold in accordance with a prescription

written by a UAE licensed doctor within the last 6 months. The

prescription must state the doctor’s name and UAE license number and

have the clinic stamp. It must have the patient’s name, the medicine

name and dose instructions must be clear.

5.9. Essential medicines must be available including at least one generic

alternative if approved in the UAE.

5.10. Shelf-life of stock must be long enough to cover a reasonable period of

use. Stock rotation is essential and existing stock must be sold before

new stock.

5.11. Quarantine of rejected and expired stock is essential and should be

clearly labelled in a lockable cupboard. This material should be returned

to the distributor (see also 3.16 above).


Code of Professional Conduct

Introduction:

In 1998, the Ministry of Health started an ambitious review of health care

ethics. The steering committee for the project has decreed that every

professional should have a clear set of ethical values relating to their

professional competence, their respect for the patient and other professionals

and their professional and personal integrity. On a day-to-day basis, the


behaviour expected of a professional is described by a code of professional

conduct.

It is recognised internationally that the contribution of the pharmacist to the care

of the patient can be found at many different levels. Pharmaceutical care can be

described as a philosophy in which the pharmacist shares the responsibility for

the outcome of drug treatment and the patient is the main beneficiary of the

pharmacist’s action. Good Pharmacy Practice is the application of

Pharmaceutical Care within a safe and carefully managed professional

framework. Such a framework will include minimum service standards, written

operating procedures and a code of conduct.

This code describes a code of professional conduct for Pharmacists and their

staff. While pharmacists work in a wide range of roles, it is hoped that this code

is general enough to meet the needs of all pharmacists in the government sector.

It is in line with the Ministry of Health’s professional general code of conduct

for personnel and promotes and protects the interests of patients in accordance

with Muslim values and internationally recognised health care ethics. This code

is based upon three core values; Competence, Respect and Integrity. The

Pharmacy code of conduct has been written according the same structure.

Principle 1- Competence

A competent pharmacist will provide the best pharmaceutical care possible in a

scientific and compassionate way. It requires the pharmacist to have the

necessary skills for the job.

Among other things, a competent Pharmacist will;

1-1- Maintain his / her professional competence through lifelong learning.


1-2- Be able to communicate with the patient or their carer (this may be via an

interpreter, see also Respect 2-2).

1-3- Act as the patients advocate through their active participation in

multidisciplinary teams.

1-4- Make it their duty to review, maintain and improve their knowledge and

abilities as new medications and other health technologies become available.

1-5- Ensure that they receive adequate in-service training for any service they

are asked to perform.

1-6- Have membership of an internationally recognized, pharmaceutical

organization.

1-7- Have knowledge of first-aid, especially if they work in hospitals and health

centres.

1-8- Take responsibility for the competency of the staff who they directly

supervise.

Principle 2- Respect

A pharmacist prime concern must be for the good of every patient and other

members of the community. Among other things, respect includes:

Respect for the patients culture, race, class, gender

2-1- A pharmacist respects the cultural needs and unique lifestyle of patients.

2-2- When the pharmacist does not have the necessary competence in the

language of the patient they must ensure that a competent interpreter is available

(see also competence 1-2).

2-3- A Pharmacist is always ready to advocate for the basic rights of a patient.

Respect for the patients right to receive safe medicine

2-4- The patient should never be exposed to an unreasonable or uninformed risk

of serious drug related injury


2-5- They should not supply a medicine if there is doubt as to the quality, safety

or effectiveness of a medicine for that patient.

2-6- If there is any uncertainty about the interpretation of the prescription the

pharmacist should make every effort to contact the prescriber to clarify the

prescription and ensure that it is safe.

Respect for fellow professionals and the profession of Pharmacy

2-7- A pharmacist should do nothing to undermine the patient’s confidence in

the prescriber.

2-8- A pharmacist must at all times adhere to the laws and regulations

applicable to the ethical practice of pharmacy in the UAE.

2-9- A pharmacist takes responsibility for their own professional activities and

for all activities performed under their direct supervision

Respect for the environment

2-10- All reasonable care must be taken when disposing of unwanted medicines

and chemicals and other materials.

Principle 3- Integrity

The Pharmacist must be seen to be honest and fair in all their dealings. They

will never take advantage of their privileged position for personal gain.

Amongst other things, integrity includes;

Maintaining the confidentiality of the medical record

3-1- The pharmacist must uphold the confidentiality of any information

acquired in the course of professional practice relating to patients and their

families.


3-2- There are several rare, but important exceptions to this principle and

include; where the life of the patient may be at risk, where a court order

demands disclosure, where an officer with authority under law demands

disclosure, where the patient, or, a legal guardian of the patient demands

disclosure. In all such cases the disclosure should be kept to the minimum.

3-3- Pharmacists must take all reasonable steps to ensure that confidential

information in their direct control remains restricted. Confidential data extends

beyond the medical details and includes address, telephone, and any family or

financial data contained in the medical record and hospital registration details.

3-4- When patient data is used for teaching purposes all efforts must be made to

conceal the source of the data.

Carrying out all responsibilities and duties in a fair and honest manner

3-5- A pharmacist must act with honesty and integrity at all times and should

not do anything that brings the MOH or their professional organisation into

disrepute.

3-6- A pharmacist must live according to reasonably expected standards of

behaviour both within and outside of their professional practice.

3-7- A pharmacist must keep themselves up to date with any changes in the

laws and regulations that affect their area of practice. They must seek guidance

(from the MOH) on any area they are not clear about.

3-8- The pharmacist should encourage transparency in all financial and

contractual matters.

Not taking advantage of their privileged position

3-9- A pharmacist must never allow personal benefit to interfere with their

professional judgement.

3-10- They should not agree to promote or supply specific medicines or devices

in response to financial benefits, gifts or hospitality.


3-11- When a pharmacist is facing a clear, or potential conflict of interests, the

pharmacist should make this known and abstain from the making decisions on

the affected area of policy or practice.

They must work according to the official policy and procedures of the

MOH

3-12- The pharmacist should have clear, written minimum standards for the

level of service provided in their hospital, health centre or store etc.

3-13- The pharmacist must only dispense valid prescriptions that are written and

valid according to current regulations.

3-14- They are responsible for ensuring that the quality of medicine they supply

is adequate and that the quantity supplied is not excessive, especially for

medicines with potential for abuse or dependence or if this could lead to waste

e.g. due to a short-shelf-life.

3-15- The pharmacist must not change the quality or quantity of the prescription

without agreement from the doctor or other official directive.

3-16- They must not dispense free promotional samples or expired medicines,

including medicine that would expire within the intended period of use.

3-17- Failure to comply with the written standards due to limitations in working

conditions must be reported to the senior manager.

3-18- Pharmacists should respond to emergency requests and should cooperate

fully with arrangements that ensure 24-hour access to a pharmacist.

Professional independence

3-19- The pharmacist must avoid any situation which will present a conflict of

interest that compromises their professional judgement

3-20- A pharmacist must neither agree to practice under conditions that

compromise their professional independence, judgement or integrity, nor

impose such conditions on others.


3-21- A Pharmacist right to refuse unauthorised requests for medicines must be

recognised and supported by the hospital or health centre director.

3-22- The pharmacist must be able to contact the prescriber of any medicine to

ensure that the prescription is safe.

3-23- The pharmacist must encourage, and be able to expect, a good level of

professional cooperation from doctors and nurses

Pharmacist Job Degrees in Ministry of Health in United

Arab Emirates


Chapter 2:

Policies and Regulatory Affairs,

Health Authority of Abu Dhabi

(HAAD), UAE

Pharmacy Profession: Personal Qualification

Requirement


Generic Drugs PolicyIssue Date: May 2010

Revision Date: May 2012

1 Purpose

1.1 The Health Authority – Abu Dhabi (HAAD) supports the use, within the

healthcare system in the Emirate of Abu Dhabi, of medication that provides the

optimum therapeutic benefit to patients in the most cost-effective manner.

1.2 Generic drugs can be as effective as their brand-name alternatives, but at a

lesser cost. They therefore allow patients’ access to appropriate medications at

the best possible price.Orientation to Pharmacy and Pharmacy Law (0200131)

1.3 The purpose of this Policy is to ensure that generic drugs will be prescribed

and dispensed wherever it is appropriate to do so.

2 Scope

2.1 This Policy applies to –

Pharmacists

All other Healthcare Professionals who have the authority to prescribe drugs

(Physicians)

Healthcare Providers in whose facilities such Pharmacists or Physicians are

employed.

2.2 This Policy provides that –

Physicians must (subject to certain exceptions) prescribe Drugs by their

generic names.

Pharmacists must not engage in the therapeutic substitution (For example,

amoxicillin is dispensed instead of ampicillin or ibuprofen is dispensed instead

of naproxen) of drugs.

Physicians must use a standard prescription form to prescribe drugs and

Pharmacists must take certain steps before dispensing them.

3 The Duties on Physicians

Duty to use the standard form

3.1 Any Physician who prescribes medication for a patient must –

(a) Do so by completing the standard form of prescription at Appendix A, and

(b) Complete all sections of the standard form in a legible manner, and sign and

stamp the form before issuing it to the patient, except where the medication

being prescribed is a controlled drug, in which case the standard form need not

be used.

Duty to use Generic Names


3.2 Any Physician who prescribes medication for a patient must refer to the

medication in the prescription by its Generic Name unless one of the exceptions

set out below applies.

Exceptions to the Duty to use Generic Names:

3.3 A Physician who prescribes medication for a patient may choose not to

prescribe the medication by reference to its Generic Name where that

medication is -

(a) A drug registered with the Federal Ministry of Health as an ‘over-the-

counter’ drug or ‘general sale product’,

(b) A dietary supplement or food supplement,

(c) A herbal or homeopathic remedy (a form of alternative therapy),

(d) A vaccine or insulin preparation, or

(e) A drug listed at the relevant time in Part I and part II of Annex B.

3.4 A Physician who prescribes medication for a patient may also choose not to

prescribe the medication by reference to its Generic Name where to do so would

place that patient’s health at risk because the patient -

(a) Has a documented history of an allergic or other adverse reaction to a

particular Generic Drug, or

(b) Has previously suffered unsuccessful therapeutic control with a Generic

Drug.

3.5 Where a Physician prescribes a Brand-name Drug on one of the grounds

permitted by paragraph 3.4, he or she

(a) Must also place the phrase ‘Do Not Substitute’ or the initials ‘DNS’ next to

the name of the item being prescribed,

(b) Must document the reasons for prescribing a Brand-name Drug in the patient

record, and

(c) Must be able to give the reasons for prescribing a Brand-name Drug if

requested to do so by HAAD.


4 The Duties on Pharmacists

Prohibition of therapeutic substitution

4.1 A Pharmacist must not dispense a Therapeutic Substitute for a prescribed

medication unless He or she has first obtained the consent of the prescribing

Physician.

Restriction on substitution of Brand-name Drugs

4.2 A Pharmacist must not dispense a Generic Drug in place of a prescribed

Brand-name Drug where the prescribing Physician has placed the phrase ‘Do

Not Substitute’ or the initials ‘DNS’ next to the name of the item being

prescribed.

Duties when dispensing

4.3 A Pharmacist must review a patient’s medication on each occasion before

dispensing drugs to that patient.

4.4 A Pharmacist must, in dispensing to patients on long term therapy -

(a) Be consistent over time in the selection of Generic Drugs that are dispensed,

and

(b) Where it is necessary to dispense a Generic Drug under a different brand

name to that of the same Generic Drug which was previously dispensed to the

patient, explain to the patient that the medication remains the same in substance.

4.5 Subject to the prohibitions and restriction as per sections 4.1 and 4.2, a

Pharmacist may offer the patient different drug product alternatives of the same

chemical entity with the same dose and dosage form as prescribed by the

Physician and allow the patient the opportunity to choose which product he/she

would prefer.

4 The Duty on Healthcare Providers

5.1 Each Healthcare Provider must


(a) Ensure that Healthcare Professionals employed by it at the healthcare

facilities that it operates comply with any duties placed on them under this

Policy.

(b) Have sufficient stocks of drug products to facilitate patient access to quality

and cost effective drugs and achieve compliance with the provisions of this

Policy.

(c) Maintain, and make available for HAAD audit, a list of all drug products,

brand name and their generic names along with their prices available at the

pharmacy.

(d) Maintain, and make available for HAAD audit, a list of all drug products

dispensed at the pharmacy.

(e) Comply and cooperate with the HAAD authorized auditors, as required for

inspections and audits by HAAD.

6 Enforcement and Sanctions

6.1 Where a Healthcare Professional or Healthcare Provider is in breach of a

duty under this Policy, HAAD may take any or all of the following actions –

(a) Suspend the licence of the Healthcare Professional or Healthcare Provider

for a period of time that HAAD determines to be appropriate in the

circumstances of the case,

(c) Revoke the licence of the Healthcare Professional or Healthcare Provider.

HAAD may impose sanctions in relation to any breach of this Policy in

accordance with [the HAAD Policy on Enforcement and Sanctions]. Decisions

on suspending and/or revoking of licences will be determined by considering


the circumstances of the case and consistent with the terms and procedures of

the HAAD Licensing Committee and in accordance with the measures under the

law.

7 Definitions

7.1 In this Policy, the following words and phrases shall be taken to have the

meanings given below.

Brand-name Drug A pharmaceutical product that is

manufactured and sold by its originator

or by a company acting on behalf of the

originator.

Generic Drug A pharmaceutical product that is no

longer protected by a patent or exclusive

licence held by its originator, and which

is manufactured and sold (whether under

its Generic Name or a brand name) by a

company which is neither the originator

nor a company acting on behalf of the

originator.

Generic Name The name of the active pharmaceutical

ingredient within a form of medication.

Healthcare Professional An individual working in the healthcare

sector in the Emirate of Abu Dhabi who

is required to hold a licence from HAAD.

Generic substitution Pharmacist initiated act by which a

different brand or unbranded drug

product is dispensed by the Pharmacists

without substituting the chemical entity


and in the same dose and dosage form as

prescribed by the Physician.

Healthcare Provider An entity operating a healthcare facility

in the Emirate of Abu Dhabi which is

required to hold a licence from HAAD.

Pharmacist A Healthcare Professional who is

authorised by HAAD to practice as a

pharmacist in the Emirate of Abu Dhabi.

Physician A Healthcare Professional who is

authorised by HAAD to prescribe drugs

in the Emirate of Abu Dhabi.

Therapeutic Substitution A drug which, in its relationship to a

prescribed drug, is –

(i) Within the same therapeutic category

but chemically different (e.g. which has

the same relationship to the prescribed

drug as ranitidine has to cimetidine, or

chloramphenicol has to erythromycin), or

(ii) A different moiety of the same parent compound (e.g. which has the same relationship to the prescribed drug as ofloxacin has to ciprofloxacin: second generation quinolone antibiotics).

8 Guidance

8.1 Further information for guidance on the operation of this Policy is set out at

Appendix C.


Appendix B

Medication which may be Prescribed by Reference to Brand-

Name Drugs

The lists in this Appendix are subject to periodic review and alteration at the

discretion of HAAD.

The pharmaceutical products listed below are not required to be prescribed by

reference to their Generic Names. They have been included on the list based on

the specific characteristics of the drug and/or disease to be treated.

Part I

Drugs with a Narrow Therapeutic Range

These Drugs contain certain substances which are subject to therapeutic drug

concentration or pharmacodynamic monitoring.

(1) Carbamazipine (anticonvulsant and mood stabilizing drug)

(2) Cyclosporin (immunosuppressant drug)

(3) Digoxin (congestive heart failure)

(4) Ethosuximide (anticonvulsant)

(5) Lithium (bipolar disorder)

(6) Methotrexate (treatment of cancer)

(7) Phenytoin (antiepileptic)

(8) Valproic acid (anticonvulsant and mood-stabilizing drug)

(9) Warfarin (anticoagulant)

(10) Theophylline (COPD and asthma)

Part II

Other Drugs- Other than drugs of a narrow therapeutic range.

[None currently listed]


Appendix C

Guidance

General Guidance

(1) HAAD Pharma /Medicines and Medical Products Department will oversee

the implementation of the Generic Drug Policy in the Emirate of Abu Dhabi. It

will work collaboratively with all concerned stakeholders including the Health

Compliance Division and Health Insurance companies to establish good generic

drug prescribing and dispensing practices in the Emirate.

(2) HAAD encourages generic substitution by Pharmacists. In doing so,

Pharmacists should prioritize and choose the most cost-effective generic drugs

for the patients.

(3) Physicians and Pharmacists will be trained and encouraged to the proper

way of utilisation and the economic benefits of generic drugs. HAAD, in

conjunction with the Federal Ministry of Health, will where appropriate inform

Healthcare Professionals about the bioequivalence of generic drugs, including

the decisional criteria used to determine the bioequivalence of individual

products.

(3) Physicians should use the standard prescription format (Refer appendix II)

for prescribing drugs to their patients. They should legibly fill in all the fields

and have the prescription duly signed and stamped before issuing it to the

patient.

(4) Physicians have to prescribe using the generic name of the drugs, unless

specified otherwise, as in the Policy. The generic prescribing should be, for

example as:


(5) ‘Refill’ denotes the process to facilitate the patients receiving their

maintenance medications from the Pharmacist, without referring to the

Physician, within the limits of the law. In the above prescription, as the

Physician denoted 1 under refill, the patient can approach the Pharmacy again

(after consumption of his first month medication) and get his prescription filled

(refilled) for another month, without referring back to his Physician.

Pharmacists shall then document the number of refills with the date on the back

of prescription.

(6) Physicians may prescribe brand-name medications (other than those listed at

paragraph 3.3 of the Policy) by designating the phrase “DNS” only for those

circumstances mentioned in paragraph 3.4.

(7) Healthcare Professionals must report all Adverse Reactions and Medication

Errors to the HAAD Pharmacovigilance Center through the Adverse Reaction

and Medication Error Reporting Forms (please see contact details below). They

should be particularly vigilant in identifying and reporting adverse events that

may be related to generic substitution.


(8) The dispensing Pharmacist should counsel the patient, and explain to

him/her about differing brand names, so that the patient appreciates the

continuity of his/her medicines. The three parties involved in the medicine

supply process (Physician, Pharmacist and patient) may all use different names

for a medicine, which may be confusing and potentially risky. When a

prescription for a generic drug is refilled (e.g. for a patient with a chronic

disease), changing the manufacturer should be discouraged, whenever possible,

to avoid confusion for the patient.

(9) Physicians may submit a request to HAAD, if they consider that a particular

drug/drug molecule (other than those listed at paragraph 3.3 of the Policy),

needs to be permanently exempted from generic prescribing. All requests in this

regard should be made only through the ‘Exemption Request Form’ (see

below). Applicable sections of the form should be filled in as completely as

possible and submitted directly to HAAD Pharma/Medicines and Medical

Products Department or through email or fax (see contact details below).

(10) A committee comprised of experts from ‘Pharma/Medicines and Medical

Products Department’ and ‘Pharmacy and Therapeutic Committee’ at HAAD

will scientifically review a Physician’s request for exemption. If required, the

Physician may be called upon before the committee to provide his medical

judgments with cost consideration to substantiate his request.

(11) The decision of the expert committee shall be final and binding and will be

communicated to the concerned Physician through email and/or fax. If the

committee recommends the drug for exemption from Generic Prescribing, it

will be added to the list at Appendix B of the Policy.

(12) For more information on the Generic Drug Policy, copies of the Adverse

Reaction reporting form, or to submit an Exemption Request Form, Healthcare

Professionals are requested to contact the following through any of their

preferred means:


Health Authority - Abu DhabiPharma /Medicines and Medical Products DepartmentPharmacovigilance Center.Phone: 02 4193 586, 348, 580.Fax: 02 449 6679Email: [email protected]


mailto:[email protected]

Policy on the Expiry Date of Medicines, Medical Consumables and Chemicals in Public Pharmacy

Issue Date: October 2007Revision Date: October 2009

1. Purpose

The aim of this policy is to standardize the process of identifying, tracking and

checking expiry dates of medicines, medical consumables and chemicals in

public pharmacies and pharmacy stores.

2. Policy Statement

Health Authority Abu Dhabi (HAAD) states that, all public Health Care

Facilities (HCF’s) shall follow the standard guidelines on identification and

checking of expiry dates of medicines, medical consumables and chemicals in

their pharmacies and pharmacy stores:

2.1. The expiry date of the product may be written as:

dd/mm/yy or mm/yy.

If the expiry date is written as:

dd/mm/yy: then the product is considered expired on that specified date.

But if the expiry date is written as:

mm/yy: the product shall expire on the last day of the specified month

2.2. All products shall be stored as specified by the manufacturer to maintain

stability of the products which may be affected by environmental conditions

(Good Storage Practices to be followed, Reference: WHO Guidelines).

2.3. For open medicine containers, the expiry dates are identified in the attached

table “expiry of open medicine containers in patient care area” (Appendix I) or

as per the manufacturer date, whichever is less.


2.4. Any medicine with unknown expiry date shall be treated as expired

medicine and disposed.

2.5. This policy is applicable for all public pharmacy and pharmacy stores in the

Emirate of Abu Dhabi and is effective immediately.

3. Scope

To implement best practices, to improve efficiency, proper utilization and

patient safety in regards to medicines, medical consumables and chemicals in

public pharmacies and pharmacy stores.

4. Target Audience

Health care professionals, pharmacists, and staff working in: purchasing,

material management, stores and warehouses.

5. Responsibility

- It is the responsibility of the health care staff in the public HCF’s pharmacies,

stores, warehouses, purchasing and material management to comply with the

policy and implement the standard practice.

- It is the responsibility of Drugs and Medical Products Department in HAAD to

audit and confirm the compliance of HCF’s with the policy.

6. Procedure

6.1 On receiving any new batch of medicines, medical consumable or chemical,

the staff involved shall check the expiry date on the outer package of the

product.

6.2 All staff dealing with medicines or medical products shall check the expiry

date of the product prior to dispensing or using it.

6.3 The expiry date on the product must be visible and clear, if not, the staff

shall refuse to accept or keep the product.

6.4 The products in all areas of health care facilities should be stored under the

conditions specified by the manufacturer and according to guidelines of Good

Storage Practice (Reference: WHO Guidelines).Orientation to Pharmacy and Pharmacy Law (0200131)

6.5 The staff shall check the expiry date of the products on regular basis

according to their approved facility procedure; the products with near expiry

date shall be flagged and kept in front of the shelf.

6.6 In outpatient clinics, pharmacists are encouraged to dispense medicines with

at least two months validity until the expiry date (example: if the medicine

expires at 10/07,the pharmacist shall dispense the medicine to the outpatients till

the end of 08/07, after this date, the medicine should not be dispensed to

outpatients). If there is no alternative, the pharmacists must clearly label the

medicine and inform the patient of the expiry date.

6.7 For open containers of medicines in patient care areas, staff shall follow the

attached table for the expiry date (Appendix I), or the manufacturer expiry date,

whichever is less. The expiry date must be written on the label of the container.

6.8 For powders for reconstitution, manufacturer instructions shall be followed

for expiry after reconstitution.

6.9 If a medicine is dispensed from bulk pack, the expiry date of the medicine

must be written on the label in addition to name of the medicine and lot number.

6.10 For formulated medicines prepared in the pharmacy, the expiry date shall

be determined as recommended by the reference used for this formulation.

6.11 All expired medicines, chemicals and medical products shall be collected,

labelled clearly as expired items and kept in a separate place for proper disposal.

7. Definitions and Abbreviations

Expiry date It is the date before which the quality of a

medicine or medical products remains

acceptable for its intended use. It is

predicted from stability tests under

general / normal storage conditions or by


accelerated stability testing under

extreme conditions.

Medicine is a drug taken to cure and/or ameliorate

any symptoms of an illness or medical

condition, or may be used as preventive

medicine that has future benefits but does

not treat any existing or pre-existing

diseases or symptoms.

Medical consumable Any product which intended to be used

for a medical purpose other than

medicine, ex. Diagnostic kits, biological

products, syringes, etc…

Chemical Includes raw materials, active

pharmaceutical ingredients and excipients

used in compounding.


9. Appendix I

Table of “Expiry Date of Open Medicine Containers in Patient Care Areas”

• If any signs of deterioration or physical changes seen on the product, discard it

immediately.

• If the manufacturer expiry date is less than the assigned date, use the

manufacturer’s expiry date.

• Assure the integrity of injection port each time vial is entered.

• Good Storage Conditions guidelines should be followed.
