FAQ
Sitemap
Legal Notices
Contacts
Hrv
About HALMED
Medicinal Products
Medical Devices
Distribution, Manufacturing and Inspection
Pharmacovigilance
News and Educations
Medicinal Products
Homepage
Medicinal Products
Instructions for Applicants
Archive – Croatia in the European Union – Guidelines and Useful Information
For
Patients and Public
For
Health Care Professionals
For
Industry Representatives
Medicinal Products Database
Information On Medicinal Products
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
Archive - Variation Applications as a Result of a Referral Procedure
Archive – Croatia in the European Union – Guidelines and Useful Information
Centrally Authorised Products (CAPs)
Medicinal Products Authorised through the Mutual Recognition procedure (MRP), Decentralised procedure (DCP) and National procedure (NP)
Information to Marketing Authorisation Holders on the Application Submission before the Accession to the EU
MRP & DCP and EU Enlargement - New Version of CMDh's Instructions
Marketing Medicinal Product Batches after the Accession of Croatia to the EU
Import of Medicinal Products from Third Countries after the Accession of Croatia to the EU
Requirements for ICSR Reports after the Croatian Accession to the EU
Deadlines for the Submission of Applications for Special and Regular Quality Control before the Accession to the EU
Anticipated National Specificities in Medicinal Product Documentation and the Procedure for Issuing Marketing Authorisations after the Accession of Croatia to the EU
Importing Active Ingredients from Third Countries after the Accession of Croatia to the EU
News Related to Importing Active Substances from Third Countries after the Accession of Croatia to the EU (10 August 2015) - NEW
Electronic Submission of Information on Medicines after Croatia's Accession to the EU
Import of Active Substances from Third Countries after the Accession of Croatia to the EU
Requirements for Submissions of PSURs to HALMED
Drug utilisation
Pharmacopoeia
Variation Applications - Referrals, PSUSA Procedures and PRAC Signals
Official Medicines Control Laboratory Division - OMCL
For Patients