Brussels, 27/05/2011 (Agence Europe) - The Council today adopted a directive on Friday 27 May (the Latvian delegation abstained) aimed at preventing falsified medicines from entering into the legal supply chain. The text reflects the first reading agreement reached with the European Parliament. Member states will have 18 months to transpose the new rules into national law.
The new directive includes inter alia the following provisions: - medicines subject to prescription must bear safety features which should allow verification of the authenticity and identification of individual packs throughout the supply chain, and provide evidence of tampering; - the manufacture of active substances intended for use in medicinal products must follow good manufacturing practice regardless of whether these ingredients are manufactured in the EU or imported; - importers, manufacturers and distributors of active substances must be registered with the competent authority as brokers of medicinal products; - the new directive also contains provisions aimed at protection patients from receiving falsified medicines through the sale of medicines via the internet. (L.C./transl.rt)