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The Sector for Administrative support receives and conducts a pre-validation assessment of the applications (in paper or electronic format) for a marketing authorisation for new medicinal products, for renewals of the marketing authorization of medicinal products, and for applications for variations and additional for the previously mentioned applications.

After applications data are introduced to the PHS electronic database and they are distributed to the assessors.

The Sector is also responsible for processing (receipt of applications, validation, correspondence with the applicant, follow timelines) the mutual recognition procedure applications.

In addition, the sector has the responsibility of archiving and updating the dossiers of medicinal products based on submission of new documents.

For relevant documents and fees concerning application forms for marketing authorization for new products, renewals and variations of marketing authorization licenses please follow the link below.

APPLICATIONS/FEES




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