Distribution, Manufacturing and Inspection

Instructions for submitting the application for the importing of medicinal products and veterinary medicinal products

The applicant is obliged to submit the following documents and information to the HALMED Registry office for the granting of authorisation for importing of medicinal products and veterinary medicinal products:

  • Written application (should contain the full name and registered address of the legal or natural person acting as the applicant)
  • Manufacturing site for all medicinal products from the list for which the request is submitted
  • Certificate of good manufacturing practice issued by the competent body of an EU member state for all manufacturing locations and pharmaceutical forms covered by the manufacturing authorisation
  • Completed Registration Form MANUFACTURING AND IMPORTING for Granting/Variation of Manufacturing Authorisation (available in the section Forms) along with accompanying data and documents in the order given in the form
  • Proof of paid expenses of the procedure of approval, based on HALMED’s pricelist of fees and services
  • Proof of paid administrative fee

All additional enquiries can be sent to HALMED via email inspektorat@halmed.hr.