Medicinal Products
Medicinal Products Database
Medicinal Products Database contains information on all medicinal products with marketing authorisation granted by HALMED as well as on medicinal products authorised by European Commission, based on the scientific assessment by European Medicines Agency (EMA).
moreInterchangeable medicinal products
Variation Applications - Referrals, PSUSA Procedures and PRAC Signals
Instructions for Applicants
- Procedure for Granting Marketing Authorisation
- Renewal of Marketing Authorisation
- Variations
- Transfer of Marketing Authorisation
- MRP and DCP Procedures - Specific National Requirements
- Croatia as a Reference Member State (RMS) in MRP and DCP Procedures
- Forms
- Submission of Scientific Advice Application
- Instructions and product information templates (QRD) in the national procedure
- The mock-up of medicinal product packaging
- Instructions for Implementation of Braille Script on the Packaging
- Instructions About the Readability and Simplicity Testing of the Package Leaflet
- Instructions for the Name of a Medicinal Product
- Recommended Translations of Scientific Terms
- Marketing Authorisation Number
- Over-the-counter (OTC) Medicines
- Preparation, Submission and Archiving of Dossiers for Medicinal Products
- Introduction of safety features on the packaging of medicinal products authorised via the national, CP, MRP and DCP procedure
- Submission of Safety Information in Clinical Trials of Medicinal Products
- Instructions for the correct interpretation of the standard terms "blister" and "unit-dose blister"
Rapid ALERT SYSTEM
Apply for NEWSLETTER
Registry Office
Important informationKsaverska cesta 4, Zagreb
Customer service: 8.00 a.m. to
3.30 p.m.
Before submitting more applications, please make an announcement at + 385 1 4884 162, +385 1 4884 165, +385 1 4884 106
E-mail:
