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Ordinances

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

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

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 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 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 (Official Gazette No. 122/14)

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

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)