Sitemap
- Medicinal Products
- Interchangeable medicinal products
- Instructions for submitting the application for granting a manufacturing authorisation for the manufacturing of medicinal products and veterinary medicinal products
- Instructions for submitting the application for the importing of medicinal products and veterinary medicinal products
- Instructions for submitting an application for registration of a manufacturer of active substances
- Instructions for submitting the application for registration of a supplier or importer of active substances
- Instructions for submitting the application for issuance of a GMP certificate for third country manufacturers
- News and Educations
- Public Educational Campaigns
- Publications and Reports
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- Publications
- Reports on Drug Utilisation
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- Annual Report on Drug Utilisation for 2023 - Croatian Document
- Annual Report on Drug Utilisation for 2022 - Croatian Document
- Annual Report on Drug Utilisation for 2021 - Croatian Document
- Annual Report on Drug Utilisation for 2020 - Croatian Document
- Annual Report on Drug Utilisation for 2019 - Croatian Document
- Annual Report on Drug Utilisation for 2018 - Croatian Document
- Annual Report on Drug Utilisation for 2017 - Croatian Document
- Annual Report on Drug Utilisation for 2016 - Croatian Document
- Annual Report on Drug Utilisation for 2015 - Croatian Document
- Annual Report on Drug Utilisation for 2014 - Croatian Document
- Annual Report on Drug Consumption for 2013 - Croatian Document
- Annual Report on Drug Consumption for 2012 - Croatian Document
- Annual Report on Drug Consumption for 2011 - Croatian Document
- Annual Report on Drug Consumption for 2010 - Croatian Document
- Annual Report on Drug Consumption for 2009 - Croatian Document
- Annual Report on Drug Consumption for 2008 - Croatian Document
- Annual Report on Drug Consumption for 2007 - Croatian Document
- Annual Report on Drug Consumption for 2006 - Croatian Document
- Annual Report on Drug Consumption for 2005 - Croatian Document
- Annual Report on Drug Consumption for 2004 - Croatian Document
- Reports on Adverse Drug Reactions
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- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2023 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2022 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2021 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2020 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2019 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2018 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2017 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2016 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2015 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2014 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2013 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2012 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2011 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2010 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2009 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2008 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2007 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2006 - Croatian Document
- Annual Report on Spontaneous Reporting of Adverse Drug Reactions for 2005 - Croatian Document
- Over-The-Counter (OTC) Medicines
- Generic and Original Medicinal Products – Equally Safe and Efficacious
- Biological and Biosimilar Medicinal Products
- Medicinal Products for Rare and Severe Diseases
- Homeopathic Medicinal Products
- Use Antibiotics Responsibly and Consciously
- Questions and Answers on Combined Contraceptives
- Falsified Medicinal Products (In Croatian)
- Over-The-Counter (OTC) Medicines
- Generic and Original Medicinal Products – Equally Safe and Efficacious
- Biological and Biosimilar Medicinal Products
- Medicinal Products for Rare and Severe Diseases
- Homeopathic Medicinal Products
- Use Antibiotics Responsibly and Consciously
- Questions and Answers on Combined Contraceptives
- Falsified Medicinal Products (In Croatian)
- 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
- Archive – Croatia in the European Union – Guidelines and Useful Information
- Questions and answers related to Periodic Safety Update Report (PSUR) submission
- Adverse Drug Reactions in Summaries of Product Characteristics and Patient Information Leaflets
- Instructions for Submitting Applications for Scientific Advice
- Questions & answers regarding the RMP and RMM submission
- Inclusion of information as regard the medicinal product status under additional monitoring
- Electronic ADR reporting in E2B standard (EudraVigilance) - Questions and Answers
- Information on Authorisation Holders' ADR reporting obligation
