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Published: 1-Mar-2004


EMEA has launched an action plan to improve its operational efficiency on human medicine controls. The plan aims to reinforce EMEA's scientific evaluation, the transparency of its procedures and the scientific capacity of its staff, and make its CPMP scientific committee more efficient.

The European Commission has issued comprehensive guidelines on information that must be written on packaging of human medicines sold in the EU. The bulletin addresses how rules apply under the amended directive 2001/83/EC, especially regarding the submission of outer packaging mock-ups for official approval. Reference 1 (below)

Guidelines on the legality of parallel import of medicinal products within the EU have been issued by the Commission. Notably, it says that if a product is already authorised for sale in an exporting Member State and is sufficiently similar to a product authorised in the importing country, that trade is legal. Indeed, parallel importing of the product would be allowed, even when authorisation for the original medicine has been withdrawn in the importing country, except to protect public health. (Reference 2 below)

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