Implementation of EU Falsified Medicines Directive

Transcription

1 Implementation of EU Falsified Medicines Directive Gerald W Heddell Director, Inspection, Enforcement & Standards Division 26th Annual EuroMeeting March 2014 ACV, Vienna Austria

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4 Falsified Medical Products Situation - Global 2013 Press Reports Europe Eur-Asia Russia Canada Egypt North America West Africa East Africa Middle East India South East Asia South America South Africa Australia

5 Worldwide Counterfeit Seizure Analysis FY 13/14

6 Worldwide Counterfeit Seizure Analysis FY 13/14

7 Worldwide Counterfeit Seizure Analysis FY 13/14

8 Worldwide Counterfeit Seizure Analysis FY 13/14

9 Worldwide Counterfeit Seizure Analysis FY 13/14

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11 HEPARIN, Obvious lessons knowledge of supply chain risk assessment and management product specification involvement with suppliers

12 Falsified Medical Products - Risks To public health: The products are sub standard in terms of their method of production and/or pharmaceutical ingredients/impurities and/or contamination Consumers and patients deserve to have a high degree of confidence when obtaining their medical products especially with a prescription from a pharmacy Counterfeit medical products undermine that level of trust, and lead to recalls, further damaging consumer confidence A number of fatalities and serious adverse reactions have been seen around the world To industry/trade: public health as above reputational damage financial impact

13 FALSIFIED MEDICINES DIRECTIVE

14 Timescale Directive 2011/62/EU on Falsified Medicinal Products - amending Directive 2001/83/EC Adopted by European Parliament & Council 8 th June 2011 Published in Official Journal of the EU 1 st July 2011 Deadline for transposition of the Directive 2 nd Jan 2013 and application of some provisions Date of application of provisions on import 2 nd July 2013 of active substances from 3 rd countries Deadline for implementation of Common 12 months after logo provisions publication of the implementing act Deadline for implementation of the provisions 36 months after concerning packaging safety features publication of the delegated act

15 FALSIFIED MEDICINES DIRECTIVE Safety features Actors in the supply chain Directive 2011/62/EU on falsified medicinal products Internet sales Active Substances Excipients

16 All APIs: Active substances Whether manufactured, imported or distributed in the EU (including those intended for export from the EU). Must comply with Good Manufacturing Practices and Good Distribution Practices for APIs. Mandatory audits performed by medicines manufacturers or third party contractor which informs the QP Declaration. All operators (manufacturers, importers, distributors of APIs) must be registered with the competent authority where they are established 60 days prior to commencement of activity (to allow for inspection).

17 New rules on AS import after 2 nd July Baseline Situation regardless of available EU-GMP or local GMP certificate API exporting country has no proven equivalence to EU GMP system Written confirmation of compliance by exporting 3 rd country Waiver 1 API exporting country is on EC list of GMP equivalent countries Waiver 2 exceptional circumstances Medicines availability issue in the EU, AND Existing EU GMP certificate (<3 years), AND EC informed

18 FMD API availability after 2 nd July?

19 Mapping of 3 rd country AS sites - summary 42 third country sources with ~1600 AS manufacturers: No. sites Source country IND CHN USA JPN CHE KOR ISR MEX BRA CAN TWA ARG TUR MYS SGP PRI THA AUS

20 Key Questions Active substances 1. How many source countries provide written confirmation? 2. How many source countries will be on EU List? 3. What is the inspection requirement and can it be met? 4. Will there be supply disruptions?

21 1. Written confirmations Confirmations being issued by: AS source Contribution (% of total manufacturers) India 30 China 28 South Korea 3 Mexico 3 Israel 2 Canada Taiwan 1 1 Turkey 1 Argentina 0.8 Malaysia Singapore South Africa 0.4 Ukraine 0.3 Indonesia 0.2 Russia

22 2. Listing of third countries (waiver 1) Listing agreed for: AS source Contribution(% of total manufacturers) USA 12 Japan 7 Switzerland 4 Australia 3 26 Under consideration for listing: Brazil 1 Singapore 0.3

23 Inspection by EU NCAs (waiver 2) Inspections to be conducted: Where there is no provision of written confirmation or listing exceptionally and where necessary to ensure the availability of medicinal products However.. EU NCAs capacity is geared to statutory requirements: Inspection of finished and investigational medicinal product manufacturers and importers A system of supervision including by inspection for AS sites in EU Inspection of third country manufacturers (or distributors) based on the risk of Directive and GMP (GDP) non-compliance EMA Rapid Reaction Team coordinating critical AS inspection priorities outside EU

24 Excipients: Excipients Appropriate GMP. Formal Risk Assessment Guidelines being developed by EMA GMDP Inspectors Working Group (UK, Denmark and Hungary) 3 Sections: 1. Determination of applicable GMP based on type of excipient. 2. Determination of Excipient Manufacturer's Risk Profile. 3. Confirmation of Application of Appropriate GMP.

25 Actors in the supply chain Actors in the supply chain: Medicinal Products Wholesale distributors: already regulated under EU rules will be listed in a EU database will be subject to Good Distribution Practices (GDP) for all activities performed on the EU territory will have to report any suspicion of falsification. Brokers: i.e. persons who are trading in medicines without physically handling them so far, not regulated under EU rules will have to be registered will have obligations similar to those of wholesale distributors.

26 Actors in the supply chain Actors in the supply chain: Active Substances EU Manufacturers, Importers and Distributers: will have to be registered Manufacturers GMP for Active Substances Importers and Distributers GDP for Active Substances

27 Internet sales Internet sales common logo Options for a "common logo" for websites legally operating online pharmacies/retailers. This logo has to be clearly displayed on every page of the website offering the medicinal products. The common logo shall be recognisable throughout the EU enabling the identification of the Member State where the online pharmacy/retailer is established. The Commission s choice of logo is:

28 Safety features Safety features: Until now, no EU rules on 'safety features' The safety features' introduced by Directive 2011/62/EU will 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. 'Safety features' will be compulsory for prescription-only medicines and for some non-prescription medicines, to be determined through implementing measures. The characteristics and technical specifications of the 'safety features, such as the unique identifier for individual packs, will be laid down in implementing measures.

29 Safety features Safety features: Impact Assessment Commission Proposals Harmonisation of the composition of the number and the data carrier Systematic verification of the safety features at the dispensing point and risk-based verification by wholesale distributors Establishment and management by stakeholders with supervision by the relevant competent authorities

30 Conclusions Further protection from Falsified Medicines Implementation largely on track Supply shortages averted White listing continuing Need to develop confidence in written confirmations Key decisions by 2014 for: Security Features/tracking Internet logo Move towards equivalence of global AS standards QP Release remains paramount

31 Thank you for your attention Gerald W Heddell Director Inspection, Enforcement and Standards Division Medicines and Healthcare Products Regulatory Agency +44 (0) gerald.heddell@mhra.gsi.gov.uk

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