Falsified Medicines Directive - Safety Features Update Catherine Neary GMP Conference 12 th November 2014
Agenda Background Delegated Act(s) Proposals Under Consideration White List & Black List Next Steps 2
Background 3
Background In early 2007, 2.1million doses of falsified medicines labelled for the treatment of prostate cancer, heart disease and schizophrenia imported into UK and entered regulated supply chain purporting to be parallel traded products 700,000 doses reached pharmacies and patients Remainder was traced and seized by MHRA or recalled from market Following 3½ year international investigation and 4 month criminal trial, a former wholesaler / parallel importer was prosecuted successfully and sentenced to 8 years imprisonment 4
Background Directive 2011/62/EU amending Directive 2001/83/EC, as regards the prevention of the entry into the legal supply chain of falsified medicinal products was published in July 2011. This Directive introduces obligatory safety features to allow verification of the authenticity of medicinal products ( unique identifier ). It places the Commission under an obligation to adopt delegated act(s) setting out the details relating to the unique identifier. 5
Background The delegated act(s) shall set out:- The characteristics and technical specifications of the unique identifier. The modalities for verification of the safety features. The provision on the establishment, management and accessibility of the repositories system in which information on the safety features is to be contained. The lists containing the medicinal products or product categories which, in the case of prescription medicines shall not bear the safety features (referred to as white list ), and in the case of non-prescription medicines shall bear the safety features (referred to as black list ). The procedures for the notification to the Commission by national competent authorities of non-prescription medicinal products judged at risk of falsification and prescription medicinal products not deemed at risk of falsification. 6
Delegated Act(s) - proposals Characteristics and technical specifications of unique identifier:- product code, serial number, national reimbursement number (if requested by MS), batch number, expiry date two-dimensional barcode The modalities for verification of the safety features Wholesalers to verify:- medicinal products received from other wholesalers who are not MAH, MIA holder or wholesaler nominated by MAH returns (from other wholesalers, pharmacies etc.) 7
Wholesalers continued Delegated Act(s) - proposals Wholesalers to verify & check out medicinal products:- distributed outside the Union recalled or withdrawn from market returned and not suitable for resale destroyed before supply to certain persons or institutions, e.g. veterinarians, dental practitioners, government institutions, universities, prisons Pharmacies to verify and check out 8
Repositories system Delegated Act(s) - proposals to be established and managed by MAHs, Manufacturers, Wholesalers, Pharmacies upload, collate, process & store information that enables identification of medicinal products and verification of authenticity of safety features shall include data elements of unique identifier, description of antitampering device, name & address of manufacturer, name & address of MAH, MS(s) where intended to be placed on market, list of wholesalers mandated by the MAH to supply or distribute 9
Delegated Act(s) - proposals Repositories system & individual repositories shall satisfy the following conditions:- be established & managed by legal entity in Union allow transfer & exchange of data among repositories allow reliable authentication of individual packs be able to transfer & exchange data with software of wholesalers & pharmacies perform so as to allow wholesalers & pharmacies to work without significant delay maintain audit trail guarantee the protection of personal data & information of a commercially confidential nature 10
Delegated Act(s) - proposals Repositories system & individual repositories shall satisfy the following conditions (continued):- shall include interfaces providing direct access to the repositories system to the following verified users:- - persons authorised to supply to the public who do not use a pharmacy or wholesaler software - competent authorities of MS, EMA & European Commission 11
Delegated Act(s) - proposals The legal entity establishing and managing the repositories shall:- put in place security procedures continuously monitor for events alerting to potential incidents of falsification provide for the immediate investigation of all potential incidents of falsification and the alerting of the authorities should the falsification be confirmed 12
White List & Black List For the purpose of complying with Article 54(o) of Directive 2001/83/EC, the holder of a manufacturing authorisation pursuant to Article 40 of that Directive ( the manufacturer ) shall, for the medicinal products he manufactures place the safety features on:- those medicinal products other than radiopharmaceuticals that are subject to prescription in the Member State where they are intended to be placed on the market, unless they are listed in Annex I those medicinal products not subject to prescription in the Member State where they are intended to be placed on the market that are listed in Annex II 13
White List & Black List White List & Black List likely to be included as Annexes I & II to Delegated Act(s) Proposals for populating the White List and Black List considered by MS and submitted to Commission by 17 th October 2014, for consolidation HPRA completed its review of products that hold a MA in Ireland, using assessment criteria in Article 54a(2) of Directive 2001/83/EC Small number of medicinal products identified as meeting criteria HPRA has written to concerned MAHs 14
Next Steps Next meeting of Expert Group of European Commission planned for December 2014 The adoption of the delegated act(s) is planned for Q1 2015 Date of application of delegated act(s) - 6 years after publication in those MS who had a system in place at the time the Falsified Medicines Directive was published - 3 years after publication in all other MS The addition of the 2D data matrix is considered a change to the labelling of the medicinal product that requires notification according to Art. 61(3) of Directive 2001/83/EC Compliance with the requirements of the act will be assessed by the HPRA during routine inspections of manufacturers and wholesalers 15
Contact Details Catherine Neary Inspector Health Products Regulatory Authority / An túdarás Rialála Táirgí Sláinte Kevin O Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2. Tel: +353 1 6764971 Fax: +353 1 6764061 catherine.neary@hpra.ie www.hpra.ie 16