Conference on MEDICRIME Convention

(Paris, 24 November 2015)

Talking points:

- As you well know, there is an EU Directive 2011/62/EU that provides the legal framework on the prevention of the entry into the legal supply chain of falsified medicinal products; the aforementioned legal act is amending the EU Directive 2001/83/EC on the Community code relating to medicinal products for human use;

- Romania adopted a law in this specific field in 2006 and since 2012 through an Emergency Ordinance the provisions of the above mentioned EU Directive have been transposed into our domestic legislation;

- According to our relevant legislation, the National Agency for Medicines and Medical Devices is in charge with the adoption and implementation of detailed rules on the safety features of medicinal products, establishing in this respect:

-         the characteristics and technical specifications of the unique identifier of the safety features that enable the authenticity of medicinal products to be verified and individual packs to be identified;

-         the list containing the medicinal products or product categories which, in the case of prescription medicines should not bear the safety features, and in the case of non-prescription medicines should bear the safety features;

-         the procedures for the notification to the European Commission of medicinal products at risk of falsification;

-         the modalities for the verification of safety features by the manufacturers, wholesalers, pharmacists and persons authorized or entitled to supply medicinal products to the public and by the competent authorities;

-         the provisions on the establishment, management and accessibility of the repository systems in which information on the safety measures, shall be contained.

- the MEDICRIME Convention is providing an extended legal basis for this specific field, having in mind that is open for signature and ratification to all 47 Council of Europe Member States (unlike 28 EU Member States that are covered by the Directive) and to other countries willing to join this international legal instrument;

- Unlike the EU Directive, the Convention’s scope of application goes beyond the falsification, being also applicable to the counterfeiting of medicinal products of for human use and covering the medical devices field too;

- a Protocol on the preventing and fighting the counterfeit and traffic of medicinal products has been concluded in 2014; on the basis of this Protocol a network of points of single contact (PSCs) has been set up at the level of the following public and private stakeholders: the Public Ministry – Prosecutor’s Office Attached to the High Court of Cassation and Justice; Romanian Intelligence Service; National Agency for Medicines and Medical Devices; Ministry of Internal Affairs; National Agency for Fiscal Administration – Customs General Directorate, National Sanitary Veterinary and Food Safety Authority; National Association of Manufacturers of Generic Medicines and the Romanian Association of International Manufacturers of Medicines.