Distribution, Manufacturing and Inspection

Instructions for submitting the application for registration of a supplier or importer of active substances

The applicant is obliged to submit the following documents and information to the HALMED Registry office for registration of a supplier or importer of active substances:

  • Written application (should contain the full name and registered address of the legal or natural person acting as the applicant)
  • Completed Form for registration of manufacturers, importers and wholesale distributors of active substances (available in the section Forms) along with accompanying data and documents in the order given in the form
  • Certificate of good manufacturing practice issued from the competent body of an EU member state for all manufacturing sites
  • Proof of paid expenses for the procedure, 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.