MHRA GDP Symposium. Novotel London West, London 8 & 10 December #GMDPevents

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1 MHRA GDP Symposium Novotel London West, London 8 & 10 December 2015

2 Enforcement activities - Impact of the falsified medicines directive Presented by: Peter Blundell, GDP Inspector

3 Impact of the falsified medicines directive Quick Recap. Update. Enforcement. 6

4 Impact of the falsified medicines directive Zyprexa ex Celebrex Casodex Celebre Lipitor x Propecia Plavix Reductil Viagra Lipitor Plavix Viread Cialis Cialis Lipitor Plavix Enbrel Seretide Evohaler Truvada

5 Operation Singapore 2007 UK Belgium China Hong Kong Singapore Supply Chain Flow of product 8

6 Operation Singapore

7 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). 10

8 Falsified Medicines Directive Timeline 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). Draft issued 2015 Delegated Act due Q

9 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. 12

10 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. 13

11 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 14

12 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

13 Impacted Products The FMD stipulates that: Medicinal products subject to prescription shall bear the safety features POM 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 GSL X 16

14 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

15 Data Repository Pharmaceutical Manufacturer Parallel Distributor Data Repository Wholesaler Healthcare Institution / Pharmacy 18

16 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

17 Simple supply chain model Pharmaceutical Manufacturer Unique serialisation randomised number Risk based Verification Healthcare Institution Pharmacy Verification prior to dispensing Patient 20

18 Wholesale - Internal Supply Chain Pharmaceutical Manufacturer Same Legal Entity Unique serialisation randomised number Risk Based Verification Aggregated Codes Disposal 21

19 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. 22

20 Supply to other Healthcare Providers Patients Healthcare Institution Pharmacy Verification Other Healthcare providers A Different Legal Entities B Export outside EU / Samples 23

21 Returns for Resale Reversion Patients Healthcare Institution Pharmacy Verification / Reversion Other Healthcare providers Original / person / premises A Different Legal Entities B Export outside EU / Samples 24

22 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. 25

23 Next steps Engage with stakeholders Pharmacists Manufacturers Wholesalers PLPI holders Draft, consult and implement legislation Articles 54(o), 54a, 57, HMR Chapter 12 & 13 26

24 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. 27

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