#GMDPevents

MHRA GDP SymposiumNovotel London West, London

8 & 10 December 2015

#GMDPevents

Enforcement activities - Impact of the falsified medicines directive

Presented by: Peter Blundell, GDP Inspector

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Impact of the falsified medicines directive

Quick Recap.

Update.

Enforcement.

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Impact of the falsified medicines directive

Seretide

EvohalerEnbrel

Lipitor

Lipitor

Propecia

Reductil

Cialis

2004

Zyprexa

ex

Casodex

Plavix

Plavix

Plavix

2007

Truvada

Viread

2011

Celebre

x

Cialis

Viagra

Lipitor

Celebrex

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Operation Singapore 2007

UK Belgium

Singapore

Hong Kong

Supply Chain – Flow of product

China

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Operation Singapore 2007

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Legislation & Guidance

Human Medicines Regulations 2012(Consolidation of Medicines Act 1968)

EU Guidelines on Good Distribution

Practice 2013

Falsified Medicines Directive 2011(Transposed into UK Law - August 2013).

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Falsified Medicines Directive Timeline

Draft issued 2015

Delegated Act due Q1 2016

July 2011 – Published in

EC OJ

January 2013 – Transposed

in to UK Law

2019– Introduction of Safety

Features in UK (3 Years)

2022 – Introduction of Safety

Features in EU States with

pre-existing measures (6 yrs).

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Falsified Medicines Directive

Strengthens the controls and checks applied to medicines as

they move through the legitimate supply chain.

Formalised GMP expectations for Manufacturers

(verification of authenticity of API & excipients)

Introduced the concept of brokering and registration in EEA

Extended the requirement for a Wholesale Dealer’s Licence / Authorisation

for export to third countries

Placed obligations on licence holders to report any suspected falsified

medicines.

Introduced a common internet logo for distance selling.

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Falsified Medicines Definition

Any medicinal product with a false representation of:

a) its identity, including its packaging, and labelling, its name or its composition as regards any of the ingredients including excipients and the strength of those ingredients;

b) its source, including its manufacturer, its country of manufacturing, its country of origin or its marketing authorisation holder; or

c) its history, including the records and documents relating to the distribution channels used.

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Falsified Medicines Directive

Introduction of safety features (mandatory seals and unique pack identification) on packaging for certain medicines to provide assurance to patients of the authenticity of medicines

Introduced to enable wholesale distributors and pharmacists:

• to verify the authenticity of the medicinal product,

• to identify individual packs,

• to verify, by means of a device, whether the outer packaging has been tampered with

Subject of the Delegated Act

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Unique Identifier

The composition, format and carrier of the

unique identifier will be:

• fully harmonised across the EU

• placed in a 2D barcode

• contain the manufacturer code, a

serialisation number, a national

reimbursement number (if present),

the batch number and the expiry

date

• Additional Human Readable Code.

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Impacted Products

The FMD stipulates that:

Medicinal products subject to prescription shall

bear the safety features

Medicinal products not subject to prescription

shall not bear the safety features unless they

have been listed by the Commission in the

delegated act – under consultation

Batch numbers must be recorded for all products

which carry additional safety features.

P

GSLX

POM

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Data Repository

The repository containing the

unique identifiers will be set up

and managed by stakeholders.

Verification System suppliers can

supply further information on data

requirements UK ESM Stand

National competent authorities

will be able to access and

supervise the database.

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Data Repository

Parallel DistributorPharmaceutical

Manufacturer

Data Repository

Wholesaler

Healthcare Institution / Pharmacy

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Verification of Authenticity

Medicine authenticity will be guaranteed by an end-to-end

verification system.

• verification prior to dispensing

• supplemented by risk-based verifications by wholesale distributors.

• medicines at higher risk of falsification (returns or medicines not being

distributed directly by manufacturers) additionally checked at

wholesalers.

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Simple supply chain model

Risk based Verification

Verification prior to dispensing

Pharmaceutical

Manufacturer

Patient

Healthcare Institution

PharmacyUnique serialisation

randomised number

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Wholesale - Internal Supply Chain

Pharmaceutical

Manufacturer

Unique serialisation

randomised number

Same Legal Entity

Risk Based Verification

Disposal

Aggregated Codes

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Wholesale supply – Verification and decommissioning

Member States may require, where necessary to accommodate the particular

characteristics of the supply chain on their territory, that a wholesaler verifies the

safety features and decommissions the unique identifier of a medicinal product

before he supplies that medicinal product to any of the following persons or

institutions:

(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;

(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.

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Supply to other Healthcare Providers

Healthcare Institution

Pharmacy

Other Healthcare providers

Patients

A BDifferent Legal Entities

Export outside EU / Samples

Verification

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Returns for Resale – Reversion

Healthcare Institution

Pharmacy

Other Healthcare providers

Patients

A BDifferent Legal Entities

Export outside EU / Samples

Original / person /

premises

Verification / Reversion

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Changes to packaging

• MAHs will need to update the MAs for all impacted

medicines to include:

– Tamper evident features

– Placement of the UI

• Route for regulatory approval – submission under

article 61(3) of Council Directive 2001/83/EC

– Where no impact on text placement or size – notification

– Otherwise – full application for assessment.

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Next steps

• Engage with stakeholders– Pharmacists

– Manufacturers

– Wholesalers

– PLPI holders

• Draft, consult and implement legislation– Articles 54(o), 54a, 57,

– HMR Chapter 12 & 13

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Impact of the falsified medicines directive

Summary

Implementation has been delayed – 2019

Wholesalers can use aggregated codes for bulk receipt and

internal transfers.

Still a need to check anti-tampering devices and decommission

the unique identifier prior to supply to certain customers.

Returns for resale can only reverted by same person /

premises that conducted decommissioning.

Disposals, exports and samples need to be decommissioned.

Pharmacists can still split packs.

Consultation and Transitional arrangements will be required.

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