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Falsified Medicines DirectiveInfo session for MAHs

25/4/2017

14u – 17uAuditorium at Wolubilis

Agenda

Welcome H. Van Eeckhout

MAH responsibilities in FMD JP. Engels

Products to market D. T’JampensQ&A

Interaction with the Verification system J. JanssensQ&A

Management of the Verification system P. BoudrezQ&A

Closing notes M. GryseelsT. Schmitz

2MAH Event 25/4/2017 Falsified Medicines Directive

MAH Event 25/4/2017 Falsified Medicines Directive 3

Falsified Medicines Directive

Legal framework – Directive • Directive 2011/62/EU published on 1 July 2011• To be detailed via a delegated act;• Obligatory safety features on the outer packaging of the medicines, Transposition by Member States into national law• Transpose into national law by 2 January 2013. • The transposition process is now complete. Implementation of the Falsified Medicines Directive• Outlined in EU secondary legislation (Delegated Regulation)• Published 09 Feb 2016• Time frame : implementation by 09 Feb 2019.

Philosophy : stakeholder model - managed outsourcing by government• The pharma sector will initiate, organize and finance the system

– Via special purpose VZW/ASBL – With limited involvement of government


Basic concept: Point of dispense verification

Mandated by Delegated Regulation


Basic concept: Point of dispense verification

Mandated by Delegated Regulation

6

Each MAH:Adapt packs & production line

Each MAH:Interaction with the Verification system

MAH stakeholders:Manage the Verification system

MAH Event 25/4/2017 Falsified Medicines Directive

Inte

rfac

e

Manufacturer System

System owner = Manufacturer

Interface

Parallel Distributor

System

System owner = Parallel Distributor

Para

l. D

istr.

Inte

rf.

Man

. Int

erf.

EuropeanHub

Nat. Blue Pr. Interf.

System owner = EMVO

Medicines Verification System

Wholes. Interf.

Nat. Blueprint. Interf.System owner= BeMVO National System based

on ‘blueprint standard’

Pharm. Interf.

PharmacySystem

WholesalerSystem

Interface Interface


EMVO European Medicines Verification Organization

BeMVO Belgian Medicines Verification Organization

Tree levels of organisation


HUB EMVO

BeMVS BeMVO

STAKE-HOLDERS

VZW / ASBL – member: EU stakeholders association Role and Responsibility

• Building and exploitation of HUB• Overall program management• Support for scale effects

Offices in Brussels

VZW / ASBL – 7 constituencies / 8 found. Members(Pharma.be / Febelgen / BAPI / BACHIAPB / Ophaco /BVZA-ABPH/ NVGV-ANGR)

Role and Responsibility • Building and exploitation of National MVS• Overall project management• Collection of membership fees & contributions

BeMVO under construction

All companies in medicine supply chain• MAH + Wholesalers +(Hosp.) Pharmacists

Role and Responsibility • Apply the FMD regulation• Use the MVS system

COMPANY SYSTEMS

Upl

oad

of p

rodu

ct d

ata

Verification

Time to start NOW

1. Project implementation

2. Products to market Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market

3. Interaction with the Verification system Get my GTIN codes Connect to the Hub Load and manage my codes My internal processes

4. Manage the Verification system Participate in Pilot phase Contract to National system

9

2017 2018 2019

Pre-pilot Pilot Ramp up Validation


Time to start NOW


2. Production line Do I have products in Scope? Change my Artwork Submit my Variations Modify my production line Bring products to the market



10

2017 2018 2019



Bring my products to the market

Dany T’Jampens

Scope of FMD – for Belgium (*)


(*) based on informal agreement with Belgian National Competent Authority

With NCA following scope of FMD has been defined

Use of the UI • All medicinal products subject to prescription• Plus Black List• Minus White List• Plus all reimbursable products in BE bearing a RIZIV/INAMI serial bar code today.

Use of the ATD• All medicinal products subject to prescription• Plus Black List• Minus White List• Plus all other products on a voluntary basis – based on risk assessment submission

and agreement of FAGG.

2D Matrix for products out of scope• The parties confirm that, for the products out of scope, the use of the 2D Matrix

(without a UI) will be on a voluntary basis. For these products still without a 2D Matrix the parties advise to use the CNK.

See decision table that will be published on the BeMVO website

Products to Market


Impact of FMD on Pharmaceutical Packaging -General

• The Delegated act (Commission Delegated Regulation2016/161) imposes the pharmaceutical industry to applysafety features to the medicinal products in scope of theregulation

– Unique Identifier (UI)– Two-dimensional barcode– Anti-Tampering Device

• Why?To allow the verification of the authenticity of medicinal productssubject to prescription and protect patients and business alike fromthe risks of falsified medicines

Products to Market


Impact of FMD on Pharmaceutical Packaging –Unique Identifier

• Technical specifications:– sequence of numeric or alphanumeric characters– unique to a given pack of a medicinal product– shall consist of the following data elements:

• a code allowing the identification of at least the name, the common name, thepharmaceutical form, the strength, the pack size and the pack type of themedicinal product bearing the unique identifier (‘product code’)

• a numeric or alphanumeric sequence of maximum 20 characters, generatedby a deterministic or a non-deterministic randomisation algorithm (‘serialnumber’)

• the batch number• the expiry date

– The probability that the serial number can be guessed shall benegligible and in any case lower than one in ten thousand.

– The character sequence resulting from the combination of the productcode and the serial number shall be unique to a given pack of amedicinal product until at least one year after the expiry date of thepack or five years after the pack has been released for sale ordistribution whichever is the longer period.

Products to Market


Impact of FMD on Pharmaceutical Packaging – UI –Two-Dimensional Barcode

• Barcode shall be a machine-readable Data Matrix(further: 2D matrix)

• Carrier of the unique identifier• Technical specifications for 2D matrix are presented in

Delegated Act• Quality of printing of 2D matrix to be verified by

manufacturers

Products to Market


Impact of FMD on Pharmaceutical Packaging – UI -Human Readable Form

• Content of 2D matrix must also be present in humanreadable format

– Product code– Serial number

• Not required when sum of two longest dimensions ofpackaging ≤ 10cm (e.g., eye drops)

• When human readable required, should be adjacent to 2Dmatrix

Always required

Only required on boxes > 10cm

Product Code

Serial Number

Products to Market


Impact of FMD on Pharmaceutical Packaging –Anti-Tampering Device

• No specific requirements• Manufacturer’s choice which ATD to use

– Labeling (with or without perforation)– Hot-Melt Gluing with perforation– Self-destroying folding boxes– Wrapping

Products to Market


Impact of FMD on Pharmaceutical Packaging -Conclusion

• For all products in scope of FMD, the lay-out of thesecondary packaging is about to change:– Add anti-tampering device– Add 2D matrix– Add Product Code and Serial Number– Remove linear sequential barcode

Products to Market


Post-FMD Secondary Packaging – Big Boxes –All Data Printed On-line

Products to Market


Post-FMD Secondary Packaging – Big Boxes –Reduced On-line Data Printing

Products to Market


• Box too big for exemption (> 10cm), but too small to fit all the human readable version of variable text on one panel

• There is no obligation to place LOT and EXP adjacent to the 2D matrix

• The 2D matrix, PC and SN can be printed on one panel, LOT and EXP on another panel

Post-FMD Secondary Packaging – Big Boxes – Too Large for Exemption, but too Small for Grouping

Products to Market


• Only 2D matrix• Human readable version of PC and SN

• not mandatory• may if possible

• LOT & EXP required, as before

Post-FMD Secondary Packaging – Small Boxes

Products to Market


Post-FMD Secondary Packaging – CNK – In-Scope Products

Products to Market


• For products not subject to FMD, CNK code still to be usedon the folding box

• Industry associations recommend however to evolve fromCNK code to 2D matrix also for products out of scope (forharmonization in market)

– Content of this 2D matrix will then be:• PC• Lot• EXP

– No SN is allowed for exempted products!

Post-FMD Secondary Packaging – CNK – Out-Of-Scope Products

Products to Market


Regulatory Variations - Current Requirements forPackaging Changes

• Based on circular letter 423 (24-FEB-2003) the FAMHP requests that companies are submitting the product information as per QRD template

• Version 10 of QRD has been updated to include provisions forthe implementation of the Falsified Medicines Directive. Following sections have been added:

– Section 17, UNIQUE IDENTIFIER – 2D BARCODE– Section 18, UNIQUE IDENTIFIER - HUMAN READABLE DATA

• Product Code to be identified with: PC (NL/FR/DE)• Serial Number to be identified with: SN (NL/FR/DE)

Products to Market


FMD Related Regulatory Variations – How to submit?

• Combine with any variation that is to be submitted for concernedproducts or via Art. 34 §4 notification

• Implementation period not limited to 6 months (due: Feb 9, 2019)! (1,2)

• Submit one variation for implementation of FMD requirements, even when there’s a stepwise approach, e.g.,

– Step 1: Add 2D matrix– Step 2: add anti-tampering device– Step 3: reduce blue box size (as serial barcode no longer needed)

• Grouping and cost of variations– In discussion with FAGG – Decisions to be validated by Transparency Commission

(1) EMA - http://www.ema.europa.eu/docs/en_GB/document_library/Other/2016/02/WC500201413.pdf(2) CMDh - http://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Falsified_Medicines/CMDh_345_2016_Rev00_02_2016_1.pdf

Products to Market


Impact Mock-Up Declaration

Not Significant (1) NO Declaration of no significant impact on mock-up

Significant (2) YES N/A

Regulatory Variations – Mock-Up Needed?

(1) 2D matrix replaces CNK and no other changes to packaging(2) Impact on readability of packaging

Products to Market

Pack design – Important Timelines (*)


(*) based on current views and instructions of EMVO and informal agreement with FAGG and Riziv

Tree pack situations are possible – for your convenience

1. Packs with only old serial bar code system Possible to bring old serial bar code packs on market till 08 FEB 2019

2. Packs with old serial bar code and new 2D matrix in parallel During transition it will be possible to bring packs on the market with

both old and new code on packs Possible as from today – till 09 FEB 2019 Instructions regarding pack design and variations : see

3. Packs with only new 2D matrix Packs with only 2D matrix are possible as from AUG 2018 To facilitate transition – especially for smaller packs with no

possibility to have both codes systems on pack For this to happen : all pharmacies and Riziv must agree and be

ready to work with 2D matrix system !

4. Same rules apply to ‘Prescription Bound & Not Reimbursed’ products

Products to Market


Start Preparing... NOW!

• Artwork– Analyze your artwork components

• Shared packs amongst countries → same country requirements?– If not: country specific packs? → impact on supply chain (MOQ)?

• Space for 2D matrix, anti-tampering device?

– Develop a strategy for artwork changes• Capacity, lead times, etc.• Resources & budget !!!

– Anti-Tampering Device• Define your standard (one or multiple)• Identify supplier• Testing of solution on boxes (e.g., stability study for label adhesion

on boxes / compatibility with varnish)• Patient testing

Products to Market


Start Preparing... NOW!

• Production– Printing of or labeling with 2D matrix, PC and SN

• Printing:– Adapt and validate packaging lines (technical, IPC checks, data integrity)– Random serial number generator needed

• Labeling:– Which printing company can supply labels with 2D matrix, PC and SN?– Data integrity throughout supply chain (how to protect serial number information)

– Adapt for anti-tampering device– Handling of serial numbers from generation to upload in EU hub– Working with contract manufacturing?

• Rework / Repackaging– How to change leaflets in tamper-evident boxes?

• Release process– QA/QP oversight to be defined

• Return process– How to handle returned units?– How to check whether decomissioned or not?

• Quality System– How to operate in serialized environment?

• Cost-Of-Goods?

Products to Market

Q & A


Time to start NOW





32

2017 2018 2019



Managing the product codes

Jan Janssens

GS1: Non Profit Setting Global StandardsGS1 sets Standards for identification of in collaboration with business:• Products: Global Trade Identification Numbers (GTIN)• Company/Location: Global Location Number (GLN)• Assets:

– Global Individual Asset Identifier (GIAI)– Global Returnable Asset Identifier (GRAI)

• Logistics: : Serial Shipping Container Codes (SSCC)

Standards in data Carriers & Barcodes: Data matrix, EAN, ITF, …Standards in data exchange (EDI)


Connect to System

CNK replaced by GTIN 13/14Belgian decision


Elements of GTIN 14:• Country of GS1 membership(Belgilux): 54• Company Prefix: length defining number of products possible and cost• Article Number: 2 to 5 digits for Belgium->#codes 100 to 100000 • Check Digit: check correct read out of product• Indicator: identification level: e.g. tablet, blister, sales pack, bundle, carton, …

=> ALLOCATION RULES FOR STATIC DATA SET:www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf

A GTIN in healthcare can never be re-used !

Connect to System

Next step 2D Matrix: Data Matrix ECC 200 version

AI Code

Pharma Data Set Format End indicator

01 PC GTIN 14 N14: 14 Numeric Values

17 Exp Expiry Date N6: 6 Numeric Values

10 Lot Batch N° X..20: Up to 20 Alphanumeric Values FNC1

21 SN Serial N° X..20Up to 20 Alphanumeric Values FNC1


Static data Dynamic data: Application Identifier (AI)

GTIN

Lot number

Expiration date

Production date

Serial number, …

Barcode Specifics:• L-Shaped pattern• Checkerboard pattern• Error correction• X-Dimension = one module• Margins: 1 x X-dimension

Default Pharma – data capacity requirement• Content: 24x24=> Impact size and technical requirements!

Connect to System

Action Points

Things to consider:• GS1 Membership: Local or Global Approach• Number of codes required: Company code length!• Coding Database & Allocation Methodology• Production: Technical Requirements & checks• GTIN to CNK: Set up in discussion with Stakeholders

Refunding adjust database RIZIV EDI communication set up


Connect to System

Time to start NOW





38

2017 2018 2019



Hub Processes for the MAH

Participation request Legitimacy check Contractual onboarding

Technical onboarding

Onboarding process• Managed by EMVOhttps://www.emvo-medicines.eu/eu-hub-on-boarding/• HUB is fully operational and tested - MAH started to upload data (3-6 mnths)

• Training video:https://www.youtube.com/watch?v=oF5K7UhfXlE&feature=youtu.be

FIRST : Check if your corporation is managing the connection with the Hub centrally for you? Yes,

Principle of OnBoarding Partner group all MAH to 1 connection

No,Start onboarding process with EMVO

Organize your internal processes


Connect to System

Q & A


Time to start NOW





41

2017 2018 2019



Managing the Verification system

• Delegated Regulation: the Marketing Authorization Holders are responsible for implementing and managing the Verification system Set up the not-for-profit organization BeMVO Contract the IT Service Provider Implement and roll out the Verification system Assure efficient ongoing operations

• Successful implementation - Pilot phase Distribution stakeholders MAH

Packaging & production line Connect to Hub Load data to Hub Contract BeMVO


Manage the System

Pilot phase• Pilot starts TODAY• Because of RIZIV/INAMI readiness by 2018

selected products : Rx products, not-reimbursed

MAH “evaluating” to participate as a Pilot can let this know to the BeMVO latest by 30/5/2017

MAH participating to the pilot will benefit from• Strong support (guidelines and procedures) from the BeMVO• Accelerated approval procedure at FAGG (if variation only for FMD)• Extended technical support from the IT provider• Additional information sessions

TO DO o Select product(s) to take in Piloto Artwork, submit variations & get approval o Production line & Bring to marketo Connect to Hub and load data to Hubo Contract to BeMVO (*see further)


Manage the System

Register NOW as Pilot candidate by mail to [email protected]

Financing the BeMVO and BeMVS

Pieter Boudrez

Budget criteria by BeMVO

• Lean and mean organisation– Max 2 headcounts staff– Quality, reporting, communication, link with IT-provider– Low cost structure (offices, multistakeholder…)

• EMVS contribution• Unforeseen expenses possible (quality, EMVS, blueprint

deviations…)• Buffer needed but will be brought to minimum reserve within first

two years of operational BeMVO– Discount on yearly flat fee

• GD Luxembourg will pay their share


Manage the System

Budget buildup

• Constituency fees for associations – full members • One Off Registration fees per MAH• Yearly Flat fee per MAH as of february 2019

Contributions of MAH’s to be collected


Manage the System

Criteria

• Every MAH active in Belgium (on Feb, 9th 2019) has to becontracted

• Every MAH active in Belgium needs to contribute directly– Invoice per MAH

• Number of MAH’s is uncertain and volatile– FMD-compliant– Rationalisation

• Auto-check of all MAH’s to be in line with BeMVO obligations– Check scope FMD– Check structure of MAH’s within corporate organisation


Manage the System

Variabilities to manage in the budget

• Number of MAH’s• Contracting the MAH’s• Possible rationalisation

• Budget to be foreseen in total• Risk factors

• Unforeseen costs• Unforeseen changes on European level

• Payment period by MAH’s• IT-implementation density


Manage the System

Registration process

Need to register in 1 of 3 waves

Added value to register quickly:

• Ready for testing on national level• Ready for testing on European level• Time to adjust internal systems and processes• Lowers the cost on BeMVO level

Check your MAH/corporate position right now


Manage the System

After registration

• Phase till 9 february 2019– One off registration fee in 3 waves– After 31 may 2018: registration fee of 20000€ + admin cost for those

already active in Belgium

• After 9 february 2019

– New MAH: one off registration fee of 20000€/MAH– Yearly flat fee to be paid per MAH to cover operational costs– Amount to be calculated Q4 2018– If substantial reserves on BeMVO-level discount on yearly flat fee for

first 2 years will be applied


Manage the System

Wrap up Action points - registration process

• Letter of ‘invitation to registration’ will be sent to all MAH– All MAH known by FAGG (name, address,…)

• Check if your MAH will act within scope of FMD in Belgium on FEB, 9th 2019

• Sign up and indicate what wave you prefer to register into BeMVO– Lines open as of 2 may via [email protected]– Complete, sign the contract and return to BeMVO (email)– Template will be provided via website www.bemvo.be and been pushed

through umbrella organisations– Signature by authorized persons – Invoice will be sent to MAH

• Remember: – Auto control responsiblity – If no contract and/or no payment received on FEB 9th, 2019

• Registration fee – at + full rate• Potentially No access to FMD Belgium/BeMVO


Manage the System

Q & A


Key takeaways

• Overall responsibility of the MAH in the FMD stakeholder model• Check if you are concerned by the scope • Modify your pack layout and bring new designed packs to the

market• Connect to the Verification System via the Hub• Manages your codes (GTIN and serial number) and reorganize

internal processes• Participate in the Pilot for a fluent start• Take your responsibility towards the management and financing of

the Verification System

START NOW !


Closing Remarks

M. GryseelsT. Schmitz


Addenda


Your To Do’s – check list 1 – General


1. Do I have products if scope of FMD? • If one product in scope on Belgian market => be FMD compliant• Scope definition : see Addendum slide p59

2. Register yourself and sign contract with BeMVO• Make yourself ‘visible’ towards the BeMVO• All MAH should sign contract with BeMVO to access the system• Will be the only basis for invoicing of contributions• Process : see slide 52

4. Pay your One-Off Registration Fee• A first financial contribution is foreseen to cover costs of investment and

operations before FEB 2019• Process, timing and fee levels : see slide 49

5. Evaluate opportunity to joint the pilot projects• We work with fazed implementation and well defined pilot projects• Process, timing, criteria and benefits to participate in pilots : see slide 42

Your To do’s – check list 2–Your workstreams


1. What is the process of onboarding?• All requested information should be uploaded via EU Hub • This must be done by you or your OBP• Before uploading you need to onboard in the HUB• For instructions of onboarding : see slide 38

2. GTIN• For Belgian : we will work with GTIN for product identification • More information : see slides 33-36

3. Adapted pack design and (cost of) variations• Implementation of FMD will require

• Adaptation the pack design • Submission of variations

• All information about process and design rules :see slides 11-29

4. Impact assessment on your organization • Start as soon as possible the impact assessment• Potential domains : ICT functions / access management process / warehousing /

transport / …


FOR non FMD PACKSIs pack < or = 10 cm? (3)

==> Not obliged to put on pack

Possible to put adjacent (5) ? =>

PC and SN adjacent

Not possible to put adjacent (5) ?=>

free to put on wathever place/panel (3)

No obligation but if possible and willing to do

=>free to put on whatever

place/panelnot bearing code today 1 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y COMPULSARYbearing code today (7) 2 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y COMPULSARYnot bearing code today 3 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREEbearing code today (7) 4 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREEnot bearing code today 5 Y Y N Y IS AN FMD PACKbearing code today (7) 6 Y Y N Y IS AN FMD PACKnot bearing code today 7 Y Y N Y IS AN FMD PACKbearing code today (7) 8 Y Y N Y IS AN FMD PACKnot bearing code today 9 Y Y N Y IS AN FMD PACKbearing code today (7) 10 Y Y N Y IS AN FMD PACKnot bearing code today 11 Y Y N Y IS AN FMD PACKbearing code today (7) 12 Y Y N Y IS AN FMD PACKnot bearing code today 13 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREEbearing code today (7) 14 VOL Y N Y IS AN FMD PACKnot bearing code today 15 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE

bearing code today (7) (8) 16 VOL N NA - not in FMD NA - not in FMD NA - not in FMD Y Y FREE

(0) VOL = voluntary(1) N = NO Y=YES(3) Is the sum of the two largest dimensions of the pack >10 cm?(4 )Is the som of the two largest dimension of the pack > or = 10 cm? (5) Adjacent = just above, left, right or under the 2D matrix

GTIN OR CNK (6) COMPULSORY

ACCORDING TO RIZIV RULES

on black list

not on black list

Can I put a liniair code?

Can I put a 2D-Matrix

without UI?

not reimbursable

CompulsoryATD?

(0)

Compulsory2D-Matrix with UI ?

reimbursable

For FMD packs - Should Human readable PC and SN be on pack?

reimbursable

reimbursable

(8) Some cases / combinations are be purely theoritical

case number

not reimbursable

not reimbursable

Is pack > 10 cm? (3)

==> Obliged to put on pack

CHARACTERISTICS (8)

reimbursable

not reimbursable

Rx - product

on white list

not on white list

(6) For non FMD packs recommanded to evolve from CNK code and liniair bar code to GTIN and 2D matrix for harmonisation in the market. => content of 2D martrix will be : PC + LOT +EXP. Remark : SN is NOT allowed out of scope products.(7) Denomination 'bearing code today' will evolve in the futur to 'bearing a public price"

NON Rx - product

FMD SCOPE

Scope for FMD in Belgium

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