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Acts

Medicinal Products Act (Official Gazette No. 76/13)

Medical Devices Act (Official Gazette No. 76/13)

Act Implementing Regulation (EU) 2017/745 on Medical Devices and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (Official Gazette No. 100/18)

Act Implementing Regulation (EU) no 536/2014 of the European parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (in Croatian) (Official Gazette No. 14/19)

Act on Amendments to the Veterinary Medicinal Products Act (Official Gazette No. 32/19)

Act on Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use (in Croatian) (Official Gazette No. 126/2019 )

Ordinances

Ordinance on Granting Marketing Authorisations for Medicinal Products (Official Gazette No. 83/13)

Ordinance on Pharmacovigilance (Official Gazette No. 83/13)

Ordinance on Amendments to the Ordinance on Pharmacovigilance (in Croatian) (Official Gazette No. 145/21)

Guideline on Good Pharmacovigilance Practices (GVP)

Ordinance on the Conditions for Issuing Manufacturing Authorisations, on the Requirements of Good Manufacturing Practice and on the Certificate of Good Manufacturing Practice for Medicinal Products (Official Gazette No. 83/13)

Ordinance on the Requirements and Method of Establishing the Requirements of Good Manufacturing Practice and Good Practice in the Wholesale of Active Substances and on the Procedure of the Entry in the Register of Manufacturers, Importers and Wholesalers of Active Substances, and on Issuing the Certificate for the Implementation of Good Manufacturing Practice (Official Gazette No. 83/13)

Ordinance on Amendments to the Ordinance on the Requirements and Method of Establishing the Requirements of Good Manufacturing Practice and Good Practice in the Wholesale of Active Substances and on the Procedure of the Entry in the Register of Manufacturers, Importers and Wholesalers of Active Substances, and on Issuing the Certificate for the Implementation of Good Manufacturing Practice (in Croatian) (Official Gazette No. 32/21)

Ordinance on Good Practice in the Distribution of Medicinal Products, on Issuing Authorisations for Wholesale Distribution of Medicinal Products, Registration for Brokering of Medicinal Products and on Issuing Certificates on Good Practice in Wholesale Distribution of Medicinal Products (Official Gazette No. 83/13)

Ordinance on Benchmarks for the Classification of Medicinal Products and on the Prescription and Dispensing of Prescription Medicinal Products (Official Gazette No. 86/13)

Ordinance on Essential Requirements, Classification, Registration of Manufacturers in the Register of Medical Device Manufacturers, Registration of Medical Devices in the Register of Medical Devices and Conformity Assessment of Medical Devices (Official Gazette No. 84/13)

Ordinance on Specific Requirements for Medical Devices Manufactured Utilising Non-Viable Animal Tissues (Official Gazette No. 83/13)

Ordinance on Monitoring Adverse Incidents Related to Medical Device (Official Gazette No. 125/13)

Ordinance on Good Practice in the Wholesale of Medical Devices and Conditions for Entry in the Register of Wholesale Distributors of Medical Devices (Official Gazette No. 125/13)

Ordinance on Conditions for Performing Retail Sale and Granting Permits to Specialised Shops for the Retail Sale of Medical Devices (Official Gazette No. 133/13)

Ordinance on Amendments to the Ordinance on Conditions for Performing Retail Sale and Granting Permits to Specialised Shops for the Retail Sale of Medical Devices (in Croatian) (Official Gazette No. 32/21)

Ordinance on the Quality Control of Medicinal Products (Official Gazette No. 60/14)

Ordinance on the Conditions for Granting Permits to Specialised Retail Sales Outlets of Medicinal Products (Official Gazette No. 122/14)

Ordinance on the Suspension of the Placement on and Withdrawal of Medicinal Products from the Market (Official Gazette No. 122/14)

Ordinance on the Type of Data and Manner of Drafting the Report on Medicinal Product Consumption (Official Gazette No. 122/14)

Ordinance on Granting Authorisation for the Parallel Import of Medicinal Products (in Croatian) (Official Gazette No. 38/20)

Ordinance on Amendments to the Ordinance on Granting Authorisation for the Parallel Import of Medicinal Products (in Croatian) (Official Gazette No. 32/21)

Ordinance on Clinical Trials on Medicinal Products and on Good Clinical Practice (Official Gazette No. 25/15)

Ordinance on Amendments to the Ordinance on Clinical Trials on Medicinal Products and on Good Clinical Practice (in Croatian) (Official Gazette No. 32/21)

Ordinance on the Manner of Advertising Medicinal Products (Official Gazette No. 43/15)

Ordinance on the Marketing, Labelling and Advertising of Traditional Herbal Medicinal Products (Official Gazette No. 89/10)

Ordinance on Good Laboratory Practice (Official Gazette No. 73/12)

Ordinance on the Criteria for Determining the Highest Permitted Wholesale Price of a Medicinal Product, the Exceptional Increase in the Maximum Permitted Wholesale Price of a Medicinal Product and the Annually Calculated Price of a Medicinal Product (Official Gazette No. 33/19)

Ordinance on Amendments to the Ordinance on the Criteria for Determining the Highest Permitted Wholesale Price of a Medicinal Product, the Exceptional Increase in the Maximum Permitted Wholesale Price of a Medicinal Product and the Annually Calculated Price of a Medicinal Product (Official Gazette No. 72/23)New

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