Parallel import authorisation: instructions for the patient information leaflet (PIL)

An applicant for a parallel import authorisation of a medicine must now submit to the famhp the PIL draft accompanied by a form containing the information required by the regulation. This information no longer needs to be included in the PIL itself which must correspond to the latest version of the reference medicine leaflet. The PIL to which the completed form is attached on the first page shall, after approval, be attached to the parallel import authorisation.

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Last updated on 25/10/2019