Distribution, Manufacturing and Inspection

Instructions for submitting an application for registration of a manufacturer of active substances

The applicant is obliged to submit the following documents and information to the HALMED Registry office for registration of a manufacturer of active substances in the register of manufacturer, importer wholesaler:

  • 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
  • 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.