Regulating risks of falsified medicinal products in the legal distribution chain Safety features - Legal and Regulatory issues

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1 Regulating risks of falsified medicinal products in the legal distribution chain Safety features - Legal and Regulatory issues Annika Wennberg, Medical Products Agency

2 New definition Falsified human medicinal product (art directive 2001/83/EC): Any medicinal product with a false representation of its identity, including its packaging and labelling, its name or its composition its source, including its manufacturer, its country of manufacturing, its country of origin, its MAH its history, including the records and documents relating to the distribution channels used Not including unintentional quality defects and without prejudice to infringements of intellectual property rights

3 Safety features Include both unique identifier and anti-tampering device Legal base Art. 54(o) and 54a in Directive 2001/83/EC and, Art. 4 i Directive 2011/62/EU Commission delegated Regulation (EU) 2016/61 of 9 February 2016 Application from 9 February 2019 in all EU Member States Except in Italy and Greece 9 February 2025 Transitional measures practical handling of batches legally released without safety features and sold until expiry date

4 Delegated regulation on safety features main content Technical characteristics for the unique identifier Control of safety features terms and conditions for commissioning/decommissioning Manufacturers MAH Wholesalers Persons authorised or entitled to supply medicinal products to the public (pharmacies, healthcare institutions) Change of safety features parallel import/distribution Which products that shall bear or not safety features (no voluntary use) Reporting suspected incidents of falsification/tampering Immediately inform the competent authority(ies) National adaptation Repository system characteristics, content, functioning and operation

5 Control and decommissioning Controls in the whole sale distribution risk-based Packs returned from pharmacies and other wholesalers Packs not coming directly from The manufacturer MAH with a wholesale licence Wholesaler with contract with MAH Decommissioning Principle as close to the patient as possible Exception for decommissioning unit at a healthcare institution (art. 25.2) Samples required by authorities, investigational medicines Packs that cannot be returned or are destined for destruction Possibility for national derogations where wholesaler may decommission packs before delivery (art. 23)

6 Which medicinal products shall bear safety features? All human medicinal products subject to prescription (national decisions) except radioactive medicinal products and those on the white list (Annex I): Homeopatics Radionuclide generators, prekursors and kits ATMP Medical gases Certain infusion solutions and other solutions Contrast media Allergens and tests No human medicinal products not subject to prescription except those on the black list (Annex II): Omeprazol, gastro-resistant capsule, hard, 20 and 40 mg Changes to the lists by delegated acts

7 Where can you find more information? Questions and answers Safety features for medicinal products for human use (regularly updated) Implementation plans for the introduction of the safety features EMA (centrally authorised products) CMDh (DCP, MRP, National products) Website of MPA

8 Swedish perspective Amendments of Swedish law already in the Act on medicinal products, the Ordinance on medicinal products, the Act on trade in medicinal products, the Act on trade in certain medicinal products with OTC status, the Ordinance on trade in medicinal products Additional changes to laws needed as a result of the delegated regulation? the Statutes of MPA regarding labelling etc. Other issues, e.g. list of decommissioning units in healthcare institutions? Article 23 persons/institutions? Revision of existing laws to comply with the delegated regulation?

9 What do we do at the Medical Products Agency? Member State Expert support to the European Commission Regular follow-up meetings MS working groups on: Supervision of repositories inspection guideline NCA access to repository system reports and interface Traceability (including authentication of pack in parallel trade from Italy and Greece) Exchange of best practices Support the Swedish Government on adaptation issues

10 What do we do at the Medical Products Agency? Provide information on medicinal products that shall bear safety features flag in the national system on medicinal products VARA via Liiv interface for MAH, in for everybody (only marketed products) Provide information on eventual extension of the scope of the anti-tampering devise not finalised yet Information about the implementation process (on our website) New/revised statutes Supervision of the national repository system and all actors (manufacturer/mah,wholesalers, pharmacies) Functioning of the system Investigation of potential incidents of falsifications (Reimbursement, farmacovigilance/epidemiology)