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15/12/14: deadline for the submission of dossiers for marketing authorisations

As the FAMHP will be closed between Christmas and New Year, we advise you to foresee December 15, 2014 as the final date for submitting requests for new marketing authorisations, variations, renewals and requests for parallel importation for medicines for human use or veterinary use. The validation of dossiers submitted after this date will only start on January 5, 2015.

New Regulation on clinical trials

On the 27th of May a new Regulation on clinical trials was published in the European Official Journal. This new Regulation will replace the national legislation on clinical studies with medicinal products. In Belgium, this is described in the Law on experiments on the human person.

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