medicines verification systems in europe – a perspective from wholesale distributors

The European Association of Pharmaceutical Full-line Wholesalers

Groupement International de la Repartition Pharmaceutique

26 November 2015

Monika Derecque-Pois, GIRP Director General

4th Annual Pharma Packaging & Labelling

Forum

26-27 November 2015, Vienna

European Healthcare Distribution Association



Monika Derecque-Pois

GIRP Director General

Medicines Verification Systems in Europe – a perspective from wholesale distributors




AGENDA

The Falsified Medicines Directive and its Delegated Regulation on Safety Features

European Medicines Verification Organisation (EMVO) and the roll-out of National Medicines Verification Systems

GIRP and wholesale distributors perspectives on medicines verification systems

Impact on the actors in the supply chain




• Directive published 1 July 2011

• Entered into force 1 January 2013

• Contains measures to increase security of

the medicinal supply chain in Europe

1. Strengthen Good Manufacturing and

Good Distribution Practices including

the sourcing of active ingredients

2. Improve supervision of actors in the

distribution chain (e.g. wholesalers,

parallel distributors...)

3. Ensure product integrity and

authentication of medicines (safety

features and product serialisation)

Falsified Medicines Directive (FMD) 20011/62/EU




• Adopted on 2nd October 2015

• Enacting terms:

1. Characteristics and technical

specifications of the unique identifier

2. Modalities for the verification of the

safety features

3. Establishment, management and

accessibility of the repository systems

4. List of RX medicines exempted from

carrying the safety features

5. Notification procedure for exceptions

by Member States

6. Procedure for rapid assessment of

notifications

Delegated Regulation to the FMD




Implementation of the Delegated Regulation – Required in Member States 3 years after publication

Objective: Protection of patients from falsified medicines in the legal

distribution chain

Content: Pan-European system to verify the authenticity of medicinal

products

2011

2018 (2015+3) Complete Implementation

Q1 2016 Publication of

Delegated Regulation

July 2011 Publication of

FMD

36 Mon.

2019 2016

Non-compliance puts sales at risk

2013

Jan 2013 FMD except

Safety Features implemented *Italy, Belgium,

Greece have 6 years longer for implementation




AGENDA








Fundamental principles for medicines verification in the EU

• Unique identifier with randomised serial number

• Check of pack’s authenticity at point of dispense

SAFETY FEATURES

• Transactional data belongs to stakeholder that generated it, e.g. pharmacists for dispensing data

• No access to data of other stakeholders except for verification purposes DATA

• Systems governed by non-profit organisations, established and managed by relevant stakeholders

• Systems supervised by EU and/or national authorities

• Quality supervision by EDQM

GOVERNANCE

• Flexible to implement national solutions within an EU technical framework (according to User Requirement Specifications)

• Interoperable between different national systems through European Hub

SYSTEM DESIGN




Common basic concept: Unique Identifier

• Data-Matrix code, developed to ISO-standards

• Key data elements:

• Product code (GTIN/NTIN/PPN)

• Randomised unique serial number

• Expiry date

• Batch number

• National health number (where necessary)

Product #: 09876543210982

Batch: A1C2E3G4I5

Expiry: 140531

S/N: 12345AZRQF1234567890




Common basic concept: “Point of dispense verification”




Pan-European Structure

Parallel Distributor

Pharmaceutical Manufacturer

National System 1

Pharmacy

Wholesaler

Pharmacy: mandatory verification

Manufacturer: data upload + voluntary verification

Wholesaler: voluntary verification

Parallel Distributor: mandatory verification + data upload

Periodic cross-region update

European Hub

National System 2

Wholesaler Pharmacy

National System

(Blueprint)

Wholesaler Pharmacy

System design for interoperability and efficiency




The European Hub is reality and its value undisputed

Secures cross-border trade

Ensures interoperability between national systems

Supports establishment of standard interfaces

Provides cost savings for connecting manufacturers

European

Hub




Conditions for a cost-effective Pan-European system

• Leverage functionality of the European Hub

• Not more than one national system per Member State

• Not too many different service providers to supply the Member States

• Staged approach for system implementation to avoid many ‘last minute implementations‘ in parallel

• Collective administration and management of several national systems by one organisation




EMVO Stakeholders have a common vision

• Protect patients

• Secure the legal supply chain

• Be proactive as market partners

• Set up a stakeholder-governed

model that is

• Functioning

• Harmonised

• Cost-effective

• Inter-operable




EMVO members are allocated to a constituency

Membership open to other stakeholder

associations




EMVO Stakeholders take action to protect patients from falsified medicines

VISION

• Protect legal medicines supply chain throughout EU

• Comply with the FMD and the Delegated Regulation in a pan-European effective and cost-efficient way

STATUS

• Design for Pan-European system and governance in place: SecurPharm connected to the European Hub

• Start up implementation in place

PLAN

• Work with EU and national stakeholder associations towards effective rollout and collaborate with EU and national authorities




Identifying national supply chain actors

Distribution Dispensing Point Manufacturing

Other Actors?

Generic Industry

Parallel Importer

OTC Manufact

urers

Research based

Industry

Hospital Pharmacies

Community Pharmacies

Self dispensing Doctors

Wholesalers




What are the actions/tasks at national level?

• Agreement between stakeholders • Principles for cooperation

• Establish stakeholder implementation project

• Foundation of National Medicines Verification Organization (NMVO)

• Definition of technical requirements

• Select IT provider (if blueprint out of the EMVO selection)

• Provide funding

• Cooperation with national competent authority

• System implementation

System complete in Q1/2019 !




EMVO offers support for national stakeholders: “Implementation Package“ Package

available !!

• Support for project set-up

• Project organisation and project plan

• High level budget estimate

• User requirement specification for national system

• Support for selection of system provider (Blueprint)

• List of Blueprint providers

• Frame contracts with Blueprint providers

• Proposal for EMVO to act as system manager for

NMVO

• Template for a Memorandum of Understanding (MoU)

• Template for statutes of an NMVO

• Proposed cost allocation scheme between MAHs

Administrative

Technical




What’s next? First steps at national level

Build on existing knowledge and experience

Develop principles for cooperation (MoU, NMVO statutes)

Determine scope of functionality

Evaluate options to realise technical system

(Blueprint or individual national system)

Develop milestone plan

• Governance organisation

• Implementation of technical system

Plan for budgets

EMVO will provide support for national implementation




AGENDA








Wholesalers‘ responsibilities under the Delegated Regulation





Risk-based Verification





Pharmaceutical

Manufacturer Wholesaler

Pharmacy/Person

authorised to

supply medicines

to the public

Pre-wholesaler

(under contract

with MAH)

Wholesaler 1

Wholesaler 2

Deliveries from other wholesalers

Deliveries from other wholesalers

Verification of the authenticity of the Unique Identifier (Art. 20)

RETURNS




Delegated Regulation on Falsified Medicines

20. Verification of the authenticity of the unique identifier by wholesalers

A wholesaler shall verify the authenticity of the unique identifier of at least the

following medicinal products in his physical possession:

(a) medicinal products returned to him by persons authorised or entitled to

supply medicinal products to the public or by another wholesaler;

(b) medicinal products he receives from a wholesaler who is neither the

manufacturer nor the wholesaler holding the marketing authorisation nor a

wholesaler who is designated by the marketing authorisation holder, by

means of a written contract, to store and distribute the products covered

by his marketing authorisation on his behalf.





Uploading of information in the repositories system (Art. 33)

…

2. For a medicinal product bearing a unique identifier, at

least the following information shall be uploaded to the

repositories system:

…

h) a list of wholesalers who are designated by the marketing

authorisation holder, by means of a written contract, to store

and distribute the products covered by his marketing

authorisation on his behalf.

Pre-wholesaler





Derogations (Art. 21)

Verification of the authenticity of the unique identifier of a medicinal product is not required under Article 20(b) in any of the following cases: a) A medicinal product changes ownership but remains in the physical

possession of the same wholesaler

b) A medicinal product is distributed within the territory of a Member State between two warehouses belonging to the same wholesaler or the same legal entity, and no sale takes place





Verification and decommissioning of the unique identifiers by

wholesalers (Art. 22)

Distribution outside EU

Returns from persons authorised

to supply medicines to the public

– which cannot be returned to

saleable stock

Intended for destruction

Samples for competent authorities

Persons/institutions referred to

in Article 23

Wholesaler





Other cases where wholesalers are required to decommission the

unique identifier (Art. 23)

Member States may require that a wholesaler verifies the safety features and

decommissions the unique identifier of a medicinal product before it supplies that

medicinal product to any of the following persons or insitutions:

(a) persons authorised or entitled to supply medicinal products to the public who do not operate within a healthcare institution or within a pharmacy; (b) veterinarians and retailers of veterinary medicinal products; (c) dental practitioners; (d) optometrists and opticians; (e) paramedics and emergency medical practitioners;





Other cases where wholesalers are required to decommission the

unique identifier (Art. 23)

(f) armed forces, police and other governmental institutions maintaining stocks of medicinal products for the purposes of civil protection and disaster control; (g) universities and other higher education establishments using medicinal products for the purposes of research and education, with the exceptions of healthcare institutions; (h) prisons; (i) schools;

(j) hospices; (k) nursing homes.





Actions to be taken by wholesalers in case of tampering or suspected

falsifications (Art. 24)

Package has been tampered with

Verification of the safety feature

indicated that the product may not

be authentic

OR

SUPPLY AND/OR

EXPORT

INFORM

RELEVANT

COMPETENT

AUTHORITIES

Wholesaler shall

AND





Characteristics of the repositories system (Art. 35)

Each repository in the repositories system shall satisfy all of the following conditions: (a) it shall be physically located in the Union;

(b) it shall be set up and managed by a non-profit legal entity established

in the Union by manufacturers and marketing authorisation holders of medicinal products bearing the safety features and, where they have chosen to participate, wholesalers and persons authorised or entitled to supply medicinal products to the public;

(c) …





Characteristics of the repositories system (Art. 35)

(i) It shall include graphic user interfaces providing direct access

to the following users verified in accordance with Article 37(b):

(i) wholesalers and persons authorised or entitled to supply

medicinal products to the public, for the purposes of

verifying the authenticity of the unique identifier and

decommissioning it in case of failure of their own software;

(ii) national competent authorities, for the purposes referred to

in Article 39;




AGENDA








Starting point: The serialised pack

The Right Code • Bluebox Requirements • GTIN/NTIN/NHRN • Systems and Dataflow

Carton and Artwork • Pack Design • Substrate • Surface / Varnish • Preprinted Information

Tamper-Evidence • Labels? • Interaction with the

variable Data

Printing line • Printing Technology • Mechanical Handling • Inspection • Grading

You need to get this right, routinely




Point of dispense verification




Identify products needing safety features

Delegated Regulation lays down which products must carry safety features

Basic principle:

• All Rx products are included, 14 exceptions (“White list”)

• OTC products are not included, 2 exceptions (“Black list”)

Equip related packaging lines with coding

and tamper evidence technology • Establishment of internal IT system

• Establishment and testing of data upload


Responsibilities of manufacturers:



Upload data into EU hub





Add tamper evidence technology

39



• Diverse solutions for tamper-evident closure

of original manufacturer’s package exist, e.g.

– Glued cartons with/without perforation

– Security seals

– Wrap with foil

– Bottles with tamper-evident screw caps

• Manufacturers to select appropriate technology




Responsibilities of parallel distributors:

• Parallel distributors are allowed to partly or fully remove or

cover up the originator’s mandatory safety features as long

as they replace with ‘equivalent’ safety features, and without

opening the immediate packaging

• A link must be maintained between the original serial code

and that applied by the parallel distributor



Responsibilities of pharmacies and other points

of dispense

• Pharmacies are required to verify and decommission unique

identifier at the time of supplying to the public.

• No flexibility allowed in what concerns point of

decommissioning of unique identifier in a pharmacy;

• The regulation provides clarification of authentication when

dispensing unit doses.

• Human readable format of a code allows pharmacy to

continue its operations in case of technical problems…

• Additional codes permitted for purposes other than

verification




Reverting status from ‘decommissioning’

• Deadline to revert status in a pharmacy provided it hasn’t left

the premises is 10 days

• There is a number of countries where

– Pharmacists do not scan medicine packs,

– Pharmacists after receiving prescription, prepare medicines

(individual labels, unit doses, etc) for patients to be collected up

to 6 months afterwards…

– in the countries where pharmacists prepare prescribed

medication for patients to be collected in advance procedures

will need to change

UK colleagues have estimated that it will cost £ 100 min yearly

to implement and run the system in UK.


Rue de la Lois 26, 10° floor, box 14 – B-1040 Bruxelles

T: +32 2 777 99 77 F: +32 2 777 36 01 E: [email protected] W: www.girp.eu



Questions?


medicines verification systems in europe – a perspective from wholesale distributors

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