Introduction to IMVO and safety features Introduction to IMVO and

New EU Requirements for Safety
Features on Medicines Packs &
Introduction to IMVO
JULY 2016
Introduction to IMVO

IMVO = Irish Medicines Verification Organisation

New organisation which is being set up to implement EU requirements for
serialisation of medicines in Ireland as part of a series of measures to
tackle problem of falsified medicines across Europe
Falsified Medicines Directive

Falsified medicines are fake medicines that pass themselves off as real,
authorised medicines

Directive 2001/62/EU (Falsified Medicines Directive (‘FMD’)) sets out a
series of EU-wide measures to ensure medicines are safe and to control
their trade to tackle the growing problem of falsified medicines:

Obligatory safety features on the outer packaging of medicines

A common, EU-wide logo to identify legal online pharmacies and medicines
retailers – register operated in Ireland by PSI

Tougher rules on the controls and inspections of producers of active
pharmaceutical ingredients

Strengthened record-keeping requirements for wholesalers
Safety Features

Directive requires ‘safety features’ on medicines packs that enable relevant
persons to identify individual packs and verify their authenticity, i.e.
1.
Unique identifiers on each pack
2.
Anti-tamper device on outer packaging, e.g. foil seal, breakable cap,

Mandatory for most prescription-only medicines; over-the-counter (OTC)
medicines excluded (with some limited exceptions based on a risk assessment)

Legislation* setting out detailed requirements for unique identifiers published in
Feb 2016

New requirements will apply to in-scope medicines released to the EU market
from 9th February 2019
* Commission Delegated Regulation (EU) 2016/161
Anti-Tamper Devices

Manufacturer may decide what type of anti-tamper device to use on
pack

Pharmacist inspects anti-tamper device prior to dispensing to ensure it has
not been interfered with; wholesalers will also do this as required

If product is repacked, e.g. if new package leaflet in different language is
inserted by parallel distributor, then new anti-tamper device must be
applied
Unique Identifiers

Unique identifiers are embedded in a Data-Matrix (2D barcode) on pack

Five key data elements in barcode:

Manufacturer product code* (e.g. 14 digit GTIN provided by GS1)

Randomised unique serial number*

Expiry date

Batch number

Reimbursement code* (if required by MS – no decision yet in Ireland )
* Must also appear on pack in human readable form

Example:
Product #: (01)09876543210982
Batch:
(10)A1C2E3G4I5
Expiry:
(17)140531
S/N:
(21)12345AZRQF1234567890
Unique Identifiers – How will process
work?

Unique identifiers for products placed on market are stored in a national
repository for that market

A European Hub links all national repositories and facilitates cross border trade
and ‘joint’ packs

Manufacturers upload up unique identifiers into system via European Hub for
transmission to relevant national repositories

As well as checking anti-tamper device, pharmacists scan 2D barcode at
point of dispensing and unique identifiers are verified against information in
repository & ‘decommissioned’

Wholesalers also verify and/or decommission unique identifiers in certain
circumstances

Alert is generated if data in barcode differs to that in repository or is missing

See graphic on next slide
Unique Identifiers – How will process
work?
Pharmaceutical
Wholesaler
Manufacturer
Product
Flow
Generates Unique
Identifiers
Upload to
European Hub
Wholesaler
Pharmacist
Verification &
decommissioning
when dispensing
to patient & an
alert if any
problems
Verification /
decommissioning
as required
National
Medicines
Repository
Patient
Authenticate Number
Unique Identifiers – How will process
work in healthcare institutions?

Persons authorised or entitled to supply medicines to public in healthcare
institutions* will have to verify safety features and decommission unique
identifiers for in-scope medicines supplied to patients:

Process may take place any time that the medicines are in physical possession
of the institution
* Hospitals, in- or out-patient clinics or health centres

Member States may opt to permit wholesalers to verify and decommission
in-scope medicines intended for supply to hospices, nursing homes,
doctors, dentists, paramedics and some other groups
EU requirements for repositories of
unique identifiers*

Set up & managed by non-profit entity established by MA holders and
manufacturers of products with safety features

In setting up, must consult at least wholesalers, persons authorised/entitled to
supply medicines to public (pharmacists) & national competent authority

Wholesalers & pharmacists entitled to participate in legal entity on voluntary
basis at no cost

Nobody shall be required to be a member of a specific organisation to use the
repository system

Cost of repository system to borne by manufacturers

Every MS must be served by one national or supranational repository based in
EU
* Commission Delegated Regulation (EU) 2016/161 – Chapter VII
EU requirements for repositories of
unique identifiers

Complies with technical specifications in Delegated Regulation

Repositories system does not include scanners needed to read unique
identifier

Repository system structure must guarantee protection of personal data and
commercially confidential information

Security procedures in place to ensure that only legitimate users access system

Continual monitoring of repository for events suggesting possible incidents of
falsification

Immediate investigation of all such events and Commission and EMA alerted if
falsification is confirmed

Regular audits of system to verify compliance with Delegated Regulation –
audit trails to be provided to competent authorities on request
European Medicines Verification System
Research
based
industry

European Medicines Verification
System (EMVS) comprises European
Hub and national / regional
repositories of unique identifiers in
each Member State

Collaboration to oversee
implementation of unique identifier
requirements across Europe

Set up as a stakeholder-governed
model comprising industry,
pharmacists and wholesalers

Overseen at European level by
European Medicines Verification
Organisation (EMVO)
Community
pharmacists
Wholesalers
Parallel
Distributors
Generics
industry
High Level Overview of EMVS
National
System
National
System
National
System
Pharmaceutical
Manufacturer
National
System
European
Hub
Parallel
Distributor
National
System
Pharmacy
National
System
Wholesaler
Detailed Overview of EMVS
European
Hub
Parallel
Distributor
Pharmaceutical
Manufacturer
National
System 1
National
System
(Blueprint)
Pharmacy
Wholesaler
Pharmacy
National
System 2
Wholesaler
Pharmacy
Wholesaler
Features of EVMS




Must be used for all transactions that result in medicines with safety
features being placed into a country in Europe for sale
Max two points of access via European Hub for each
pharmaceutical corporation or pharmaceutical distributor
Manufacturers of in-scope products:

must upload (batch) product pack data via European Hub (cannot be
done by contract manufacturer)

must pay fees to relevant national medicines verification organisation

Not required to be member of national medicines verification
organisation to access system
National system offers standard graphic user interfaces (GUI) for
pharmacy and wholesaler software suppliers and competent
authority to connect to the repository
Features of EVMS (ctd)

Product ‘decommissioned’ by party who physically takes out it of
supply chain

System will accommodate parallel trade & multi-market ‘joint’ packs

Where parallel distributor repacks medicine and applies new safety
features, new unique identifiers are linked in repository with those of
original manufacturer batch

System will search for unique identifiers in other repositories if not found in
national repository

System functionality will facilitate recalls and European Hub will send
info. to relevant national systems

Capable of handling different coding systems, e.g. GS1 (GTIN),
German PPN (Pharmacy Product No.)
Features of EVMS (ctd)

Protocols in place to deal with exceptional events, including escalation
procedures, and Internet outages

Bulk transactions only allowed by party in possession of products (e.g.
pharmacist may decommissioning several pack simultaneously prior to
returning to wholesaler)

GAMP compliant system (‘Good Automated Manufacturing Practice’)

Full audit trails but not a track and trace system

No capability currently for aggregated codes (i.e. one code on outer
box containing multiple packs which can be scanned instead of
having to scan each individual pack)
National Blueprint System




Allows national stakeholders to join the EMVS without building system from scratch by offering
‘standard’ national verification system providing all necessary functionality

Fewer, but bigger (aggregate) systems are less costly than many (individual) smaller systems

Particularly attractive for Member States with no similar system/ infrastructure in place
EMVO has selected shortlist of 3 providers (‘blueprint providers’) – Aegate, Arvato and Solidsoft
Reply – and developed related documentation

Standard spec (‘URS’) for national systems

Template contracts & indicative costings
Key activities at country level

Review of local work practices and systems and any additional functionality required

Select one of 3 blueprint providers & finalise price and contract with them

Oversee implementation of local system
Ongoing management of system by local organisation or may be outsourced to EMVO
IMVO’s role

Role:

To set up and manage repository of unique identifiers for Ireland

To interface with European Medicines Verification Organisation (EMVO) to
ensure full interconnectivity with European Hub

To verify credentials of system users in Ireland

To levy fees on manufacturers who use system to cover the cost of the national
repository and Ireland’s share of the European Hub costs

Irish national repository will be part of EVMS

Will operate as independent legal entity (company limited by guarantee)
Who’s involved in IMVO?

Stakeholder organisations:

Innovator industry – Irish Pharmaceutical Healthcare Association (IPHA)*

Generic medicines industry – Irish Generic Medicines Association (IGMA) and
Healthcare Enterprise Alliance (HEA)

Pharmaceutical parallel distributors – Association of Irish Pharmaceutical Parallel
Distributors (AIPPD)

Pharmacists – Irish Pharmacy Union (IPU) (community pharmacists) and Hospital
Pharmacists’ Association of Ireland (HPAI)

Wholesalers – represented by Pharmaceutical Distributors Federation (PDF)
* BioPharmaChem Ireland (BPCI) also attending meetings

Working closely with Health Products Regulatory Authority (HPRA) who will be
responsible for supervising national repository
Progress with IMVO to date

Memorandum of understanding agreed between stakeholders

Work underway to set up IMVO as a not-for-profit company

Stakeholder organisations all expected to be involved as full or affiliate members

Affiliate membership open to companies & organisations who are not full members

HPRA does not intend to avail of its right to seats on the IMVO Board

Governance & Technical Advisory Groups set up

Decision to go with Blueprint approach & initial meetings in April with blueprint providers
(Aegate, Arvato and Solidsoft Reply). Follow-up workshops will take place in August

Engagement with wider industry stakeholders (manufacturers, wholesalers & MA holders)
through presentation by IMVO at HPRA FMD workshops in May 2016

External communications – HPRA, HSE, Department of Health, PSI etc.

Currently mapping all national users/stakeholders & work practices and any Irish specific
requirements

Formal consultation on proposals in July/August 2016
Governance


National systems:

Governed by independent not-for-profit organisations established and
managed by relevant stakeholders (IMVO in Ireland)

Supervised by national competent authorities (HPRA in Ireland)

Department of Health also monitoring progress
European Medicines Verification System:

Governed by EMVO which sets standards for system and has formal
agreements with national organisations

European Hub supervised by EDQM (European Directorate for Quality of
Medicines and Healthcare)

European Commission responsible for relevant EU legislation and publishes
FAQ
Funding


Two elements of cost in national organisation (IMVO):

Governance/running costs of national organisation: will be divided equally
amongst all the stakeholder organisations who opt to become members

Costs of repository system: (national repository costs and national
contribution to European Hub) will be borne by all manufacturers/MA
holders of medicinal products bearing safety features
System users also have to pay their own costs:

Manufacturers – adding safety features to packaging, creating interface
with European Hub to upload unique identifiers, etc.

Pharmacists / healthcare institutions/ wholesalers – scanners, software
system adaptation (where necessary to interface with repository)
Data Access

Transactional data belongs to stakeholder that generated it, e.g.
pharmacists own dispensing data

No access to data of other stakeholders except for verification purposes
or with their agreement

Competent authorities may access data for following purposes:


Supervising functioning of repository and investigating incidents of falsification

Reimbursement

Pharmacogivilance or pharmacoepidemiology
NB – not a track and trace system
Implications of Feb 2019 Deadline

IMVO – repository system up and running efficiently

Manufacturers:


Medicines released to market from 9th Feb 2019 onwards have anti-tamper device and 2D
bar code with unique identifiers

Unique identifiers uploaded to national repository via European Hub
Wholesalers / community pharmacists / hospital pharmacists & healthcare institutions

Scanning equipment to read barcodes

Reliable Internet connection

Software systems capable of interacting with national repository, reporting on status of
product in the repository and, if being dispensed, decommissioning it from repository
Medicines with safety features cannot be supplied to patients after 9th Feb 2019 unless safety
features have been verified and unique identifiers decommissioned in national repository