EU Falsified Medicines Directive -Recent Updates

Feb 2017

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What are falsified medicines?

• Growing threat to public health and safety in Europe • Involving nearly 2500 cases , EU Customs seized 27.4 million doses of

falsified medicines at EU borders in 2011- an almost seven-fold increase from 2007

• MHRA seized £8.6m and discovered fraudsters are infiltrating the NHS drugs supply chain and diverting medicines to street drug dealers and illegal websites – May 2014

• Falsified medicines may:• Contain low quality ingredients or the wrong doses

• Have their identity or source deliberately mislabelled

• Have fake packaging or the wrong ingredients

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Falsified Medicines Directive (FMD) 20011/62/EU

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• 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 and internet sales)

3. Ensure product integrity and

authentication of medicines (safety

features and product serialisation)

Delegated Regulation to the FMD

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• Adopted on 2nd October 2015

• Published on 9th February 2016

• Enacting terms: Safety Features

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

Requirements for safety features

Code (‘safety feature’)

+

Tamper evidence

Unique identifier

Data-Matrix Code

Randomised serial number

Product #: 09876543210982Batch: A1C2E3G4I5Expiry: 140531S/N: 12345AZRQF1234567890

Implementation 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)CompleteImplementation

9 February 2016 Publication of

Delegated Regulation

July 2011Publication of

FMD

36 Mon.

20192016

Non-compliance puts supply and sales at risk

2013

Jan 2013FMD except

Safety Features implemented *Italy, Belgium,

Greece have 6 years longer for implementation

Regulatory Perspective

• Anti-Tampering Device:– If placed on immediate packaging may impact the

regulatory dossier– New MAs • may need to include information ins section 3.2.P.2.4

and/or 3.2.P.7 of NTA Vol. 2B• Information required by day 180

– Existing MAs• Will need to update dossier• Section B.II.e. of the Variation Guidelines applies

• Compliance by February 2019https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets

Regulatory Perspective

• Unique Identifier:– Must be included in the product information annexes

and associated artwork– QRD template – new sections 17 and 18 in Annex IIIA• New MAs must comply at the time of authorisation• Existing MAs– Utilise the next regulatory intervention impacting

the packaging– If no suitable intervention notify NCA under

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

• Compliance by February 2019https://www.gov.uk/guidance/medicines-packaging-labelling-and-patient-information-leaflets

On Supply to Patient

• General provisions on the verification of the safety features

–Check the UI against the numbers held in the repository

–Ensure the tamper-evident feature is intact

• At the point of supply UI will be “decommissioned” out of the repository

• UI can be checked back into the repository in certain circumstances (10 Days)

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Manufacturers and Marketing Authorisation Holders

• Impact on manufacturers• Must develop system which will verify the UI

• Keep records

• If repacking must verify and replace UI and safety features

• Safety features are deemed equivalent if they comply with the delegated acts

• Must take action if concerns are raised and inform the NCA

• If also a wholesaler dealer the following obligations apply

Delegated Regulation –

Safety Features

Wholesaler Dealers

• Impact on Wholesalers

– Risk based verification

– Decommission the UI in specific circumstances

– Take action if issues arise and inform the NCA

– Can decommission the UI on behalf of others if flexibilities used by Member State (Article 23)

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General obligations

• Companies to upload certain information to the repositories (Master Data)

• Products recalled, withdrawn or stolen

–UI must be decommissioned

–Repository updated

• Free samples to have UI decommissioned before supply to HCPs

• Remove redundant information

Delegated Regulation –

Safety Features

Flexibilities within the Regulation

• Member states may take National decisions on some aspects of Delegated Regulation.

• Currently UK NCA are minded to– Article 2(1)(c) - Extend scope of safety features

• Anti-tamper to any

• Not extend addition of 2D bar code

– Article 4, b,iii and Article 7, 1, c - Not require a National Reimbursement Number within 2 D bar code

– Article 8 - Additional information in UI by manufacturers

– Article 23 - Require wholesalers to decommission for all organisations listed

– Artile 26, 3 - Exempt individuals from obligations of verification and decommissioning within Healthcare Institutions

Delegated Regulation –

Safety Features

NCA Timelines – key dates

• Developing initial UK position on flexibilities + legal changes on enforcement: February-December 2016

• Developing initial impact assessment : February-December 2016

• Public consultation (12 weeks): Proposed early 2017

• Review of consultation – amendments: Proposed Q2 and Q3 2017

Costs are incurred by all stakeholders

• Each stakeholder pays for costs of own installations

• Manufacturers pay for cost of verification system

Manufacturers and Marketing Authorisation

Holders

Manufacturers and Marketing Authorisation

Holders – contact EMVO to sign

up for European Hub testing

Dispensing & Verification Entities

e.g. Pharmacies and Wholesalers

Installation for pack codingVerification system (Hub & national systems)

Installations for pack verification

Pharmacy Wholesaler

Pharmaceutical

ManufacturerParallel

Distributor

EuropeanHub

European Principal Stakeholders developed a European Stakeholder Model

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Common Basic Concept:Point of Dispense Verification

Required by Delegated

Acts

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Pan-European architecture: The “National Blueprint System“ approach

National

System

PharmacyWholesaler

Pharmaceutical

Manufacturer

Parallel

Distributor

National

System

National

System

European

Hub

National

System

National

System

National

System National Blueprint

System

National Blueprint

System

National Blueprint

System

National Blueprint

System

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The UK Stakeholders 2012-2015

• Meeting regularly since 2012, with ABPI, BAEPD, BAPW, NPA, PSNI, RPS,

• Co-operation and consensus vital

– Supporting European Stakeholder Model

• Keeping stakeholders informed:

– Associations’ own members

– The Competent Authorities

– Reaching out to other parts of the medicines supply chain

– Joint seminars

– EMVO documentation was important

• BGMA joins UK ESM – 2015

• RPS/PSNI drop off

• Incorporate the UK Medicines Verification Organisation – SecurMed UK

SecurMed UK – UKMVO

SecurMed UK

• A not for profit legal entity to establish and manage the verification system

• Incorporated by Articles of Association in July 2016

• Supervised by National Competent Authority (DoH/MHRA)

• Scope governed by Delegated Regulation of Falsified Medicines Directive

EuropeanMedicines Verification

System (EMVS) Inte

rfac

e

Inte

rfac

e

Man

ufa

ctu

rer

Paralell

ManufacturerSystem

Parallel Distributor

System

Interface

Nat’l System

UK National Medicines Verification System

(NMVS)

Interface

Pharmacy

Inte

rfac

e

Wh

ole

sale

r

Wholesaler/ Distributor

System

Interface

Hospital

Interface

Other

CommunityPharmacy

System

Hospital Pharmacy

System

Other Dispensing

System

Integrated PMR

Standalone Application

NHS Hospital

Pharmacy

Private Hospital

Pharmacy

Dispensing Dr

Other Dispensing

Organisation

National Verification Systems Overview

European Medicines Verification

Organisation (EMVO)

UK National Medicines Verification Organisation (NMVO)

• Branded• Generic

EuropeanMedicines Verification

System (EMVS) Inte

rfac

e

Inte

rfac

e

Man

ufa

ctu

rer

Paralell

Manufacturer

System

Parallel Distributor

System

Interface

Nat’l System

UK Medicines Verification System

(UK MVS)

Interface

Pharmacy

Inte

rfac

e

Wh

ole

sale

r

Wholesaler/ Distributor

System

Interface

Hospital

Interface

Other

Community PhamacySystem

Hospital Pharmacy

System

Other Dispensing

System

Integrated PMR

Standalone System

NHS Hospital

Pharmacy

Private Hospital

Pharmacy

Dispensing GP

Other Healthcare Dispensing

Organisation

SecurMed UK Scope of Responsibility

Article 23Locations

• Under NCA supervisory control• Build UK MVS repository and on-board

wholesale/ pharmacy/ dispensing users• Develop business operational processes (e.g

decommissioning)• Provision of NMVS Repository to pharmacy

user community for medicines verification• Provide interfaces to pharmacy user/

software integrator community• Maintaining and operating UK MVS• Maintain service contracts with system

service provider and EMVO• Collect operational fees from MAHs• Reporting exceptions & compliance to

NCAs.• Maintain data integrity and security

Outline Plan on a Page

Who will have to pay ?

Pharmacists, wholesalers, …

Installations for pack verification

Marketing AuthorisationHolders

Installations for pack coding

Marketing AuthorisationHolders

Repository system (Hub & national systems)

Pharmacy Wholesaler

Pharmaceutical

ManufacturerParallel

Distributor

EuropeanHub

MAHs selling products in a Member State pay for respective national system and a share of the European Hub

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National Full Operation Costings

National system cost estimateSep 2015 26

System cost x k€

Average of IT service providers’ offersPre-negotiated offers vary between

average +/- 50%

NMVO cost x k€

As per system size

Hub cost x k€

Share: x % (Approx double during first 3 years to pay off loans)

Total: x k€

Annual fee per MAH: x k€

Flat fee model

Cost allocation: The Flat fee model

• The flat fee is transparent, non-discriminatory and proportionate in relation to the services received.

• Practicality• Easy way of calculating: equal division amongst MAHs and PD

• Fairness• Takes into account market activity: companies with multiple MAHs pay more

• Transparency• Simple accountancy / audit

• Predictability• Calculations based on number of active participants in the market the year

before the fee adjustment

• Balanced• A larger company often hold multiple MAH’s so will pay multiple ‘flat fees’

• Upfront payment• In order to prevent free-riders, easy calculation gives opportunity to pay

upfront

FMD AND BREXIT

• Article 50 (Brexit) – March 2017 plus 2 years

• FMD legislation passed into UK law in 2013.

• Delegated Regulation published February 2016 plus 3 years

• DH guidance • Maintain integrity of UK medicines supply chain

• Continue with implementation and contract service provider

What should manufacturers do Next?

• Prepare own serialisation and packaging lines• Engage with EMVO to ensure ready to upload

data– Participation Request– Legitimacy Check– Contractual/Commercial On-boarding

• Registration

– Technical Onboarding• Connection/Testing/Operation

• Understand Data Requirements– Master Data

Paul Mills, 19th Oct 2016, securMed

EMVS Master Data

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Product Master Data

Product code

Coding scheme

Name

Common name

Pharmaceutical form

Strength

Pack type

Pack size (Dose Count)

Product Code Status

Product Code Version

Product per Market Data

Member state ISO ID

National code

Article 57 code/PCID (TBC)

MAH ID

MAH Name

MAH Address

Serialisation Flag

List of Wholesalers with ID, name and address

Batch Data

Batch number

Expiry date

Manufacturer ID

Manufacturer Name

Manufacturer Address

Batch Number Status

Pack Data

Serial Number

Serial Number Status

1

N

1

1

N

N