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    Pan-European conference on the measures taken to prevent falsification of medicines is held in Estonia

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    On 8 and 9 November, a conference “Safer Europe without Falsified Medicines”, organised under the Estonian Presidency of the EU Council, is held in Tallinn. The conference is organised in co-operation with Estonian State Agency of Medicines, Ministry of Social Affairs, pharmaceutical manufacturers, wholesalers and pharmacies.

    The main focus of the conference is on the European Commission delegated regulation concerning the implementation of safety features of medicinal products, which will enter into force on 9 February 2019.

    “The implementation of safety features of medicinal products has been considered necessary by all parties, since the medicinal product that becomes available to the patient  must be safe, manufactured and stored in a secure manner and in accordance with the requirements,” said Maris Jesse, Deputy Secretary General on Health for the Ministry of Social Affairs. “A majority of actions set out in the regulation are currently being developed; unresolved issues will be discussed at the conference.”

    „The introduction of safety features will impose new obligations on pharmaceutical manufacturers, pharmacists, pharmaceutical wholesalers and national authorities,” said Kristin Raudsepp, Director General of the Estonian State Agency of Medicines. “The role of Estonia in the implementation of this innovation is to ensure that availability of medicinal products will not be adversely affected and that national interests are protected. All interested parties, including the European Commission, will have a say at the conference, and together they will try to find an answer to the question of whether Europe is ready for the implementation of safety features and what else needs to be done.”

    According to Riho Tapfer, Head of the Association of Pharmaceutical Manufacturers in Estonia, a pan-European repositories system will be created for the management of safety features and the principles of data exchange will be agreed. “In order to implement the new regulation, pharmaceutical manufacturers have to replace or rebuild production lines and develop databases; pharmacists and wholesalers need new scanners and governments must set up supervisory systems. Each package of the medicinal product will be checked in real time from the moment of manufacture to reaching the patient,” said Riho Tapfer.

    In 2011, the European Commission adopted a directive supplementing the existing directive on medicinal products for human use. The directive introduced safety features for medicinal products for human use, creation of the repositories system and a system for checking the safety features and adoption of a separate delegated regulation specifying how this will be done.

    The conference is organised by: Ministry of Social Affairs, Estonian State Agency of Medicines, Association of Pharmaceutical Manufacturers in Estonia, Estonian Association of Pharmaceutical Wholesalers, Estonian Pharmacies Association, Estonian Medicines Verification Organisation , European Federation of Pharmaceutical Industries and Associations (EFPIA), European Medicines Verification Organisation (EMVO), European Healthcare Distribution Association (GIRP), Pharmaceutical Group of the European Union (PGEU), European Association of Euro-Pharmaceutical Companies (EAEPC), Medicines for Europe


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