Import of medicinal products - apply for a licence

You can apply informally to the competent authority for authorisation. Your application must contain the following information:

• exact name of the applicant and details of the legal form
• Designation of the business premises (name, street, town)
• Details of the activities planned at the business premises in connection with the import
• Information on external warehouses
• Name, telephone and fax number, e-mail address
  • a competent person
  • a responsible person in the case of the import of medicinal products of human origin for direct human use
• tabular information on the medicinal products intended for import
• Details of the organisations responsible for testing

Tipcontact the competent authority before submitting the application to clarify the details.

Once the complete documentation has been submitted, the competent authority will carry out a final inspection. Only then will it decide whether to grant the import licence or reject the application by issuing a decision.