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.
20192016
Non-compliance puts sales at risk
2013
Jan 2013
FMD except
Safety Features
implemented *Italy, Belgium,
Greece have 6
years longer for
implementation

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 PointManufacturing
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

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;

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: girp@girp.org W: www.girp.eu

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