News and Educations

HALMED held a round table "Counterfeit medicines and safety features"

14.11.2014

The Agency for Medicinal Products and Medical Devices (HALMED) organised a round table "Counterfeit medicines and safety features" which was held on 11 November 2014 in Šibenik within the International regulatory and pharmacovigilance conference "Croatian Mark in the EU". Round table gathered stakeholders in the field of fighting counterfeit medicines; representatives from healthcare professionals, pharmaceutical industry, medicines retailers and wholesalers, patients, journalists, Ministry of Health, Customs Office of the Ministry of Finance, Croatian Health Insurance Fund and HALMED. Participants presented their positions and discussed the counterfeit medicines problem, as well as the prevention of the counterfeit medicines, and implementation of safety features.

Alongside the HALMED’s representatives, at the round table discussion participated: Mate Portolan (Croatian Chamber of Pharmacists), Sani Pogorilić (Innovative Pharmaceutical Initiative), Dzulijana Bundaleska (Generic Medicines Association), Jakov Radošević (representative of wholesalers), Mirjana Lerman (Ministry of Health), Andreja Šantek (media representative), Đula Rušinović Sunara (Croatian Association for Promotion of Patient’s Rights) and Marijana Bukić (Customs Office of the Ministry of Finance). At the and Ms Kristina Vitas presented the Croatian Health Insurance Fund’s position.

The problem of counterfeit medicines is at increase on the global level, which is recognised in the EU where based on the previous experience Directive 2011/62/EU of the European Parliament and Council was adopted, setting out detailed mechanisms for fighting against counterfeit medicines in legal supply chains of EU Member States. The Directive introduces the notion of safety features as one of the mechanisms for preventing the entering of counterfeit medicines into the legal supply chain. The aim of safety features is to provide identification, or confirmation of authenticity of an individual product packaging.

Back