Documents - Marketing authorisation medicines for human use

46 documents Marketing authorisation medicines for human use

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  1. Form to request withdrawal of a parallel import marketing authorisation

    Form | 12-06-2015

  2. Manual parallel import dossier structure

    Policy document | 01-06-2015

  3. Schrijfadviezen voor de geneesmiddelenbijsluiter

    Policy document | 01-01-2015

  4. MEB 15: Replica marketing authorisation (only apply to existing marketing authorisations)

    A replica marketing authorisation concerns a medicinal product which is exactly the same as the reference medicinal product, with ...

    Policy document | 28-10-2014

  5. Disinfectant products: Distinguishing between biocidal products and medicinal products (human and veterinary)

    Policy document | 01-05-2013

  6. Assessment report coagulated potato protein and hydrolysates, applicant AVEBE

    A report on the assessment of the substantial equivalence of coagulated potato protein and hydrolysates by the company AVEBE with ...

    Report | 20-07-2000