Distribution, Manufacturing and Inspection

Instructions for submitting the application for the granting of the Good Manufacturing Practice (GMP) certificate

The applicant is obliged to submit the following documents and information to the HALMED Registry office for the granting of the Good Manufacturing Practice certificate:

  • Written application (should contain the full name and registered address of the legal or natural person acting as the applicant)
  • Completed Registration Form MANUFACTURING AND IMPORTING (available in the section Forms) along with accompanying data and documents in the order given in the form
  • Classes and file reference numbers of earlier issued certificates (if applicable)
  • Proof of paid expenses for the procedure, based on HALMED’s pricelist of fees and services
  • Proof of paid administrative fee

When the application for the granting of the Good Manufacturing Practice (GMP) certificate is submitted by a manufacturer from a third country through a representative in the Republic of Croatia, in addition to information and documents from the registration form MANUFACTURING AND IMPORTING, the manufacturer is obliged to also submit the following documents:

  • A copy of provided Good Manufacturing Practice certificates for the manufacturing site
  • Written authorisation authorising the person to undertake communication with the HALMED Inspectorate
  • A written declaration by the applicant stating that the applicant will allow the person responsible for batch release of the medicinal product to perform their duties autonomously and that all the necessary resources for that will be ensured
  • A written declaration by the applicant stating that manufacturing activities will be performed in compliance with the requirements of good manufacturing practice
  • A written declaration by the applicant stating only active substances manufactured in compliance with good manufacturing practice will be used in manufacturing medicinal products
  • A written declaration that the manufacturer will produce only those medicinal products or investigational medicinal products for which a valid manufacturing authorisation exists

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