Distribution, Manufacturing and Inspection

Instructions for submitting the application for granting a manufacturing authorisation for the manufacturing 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 Manufacturing Operations:

  • Written application (should contain the full name and registered address of the legal or natural person acting as the applicant)
  • Completed 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.