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Legislation

The Cabinet of Minister's Regulations No.376 Medicinal Product Registration Procedure
Annex

The Cabinet of Minister's Regulations No.61 Regulations Regarding Pricelist for Paid Public Services Provided by the State Agency of Medicines

The Cabinet of Minister's Regulations No.899 Procedures for the Reimbursement of Expenses toward the Purchase of Medicinal Products and Medical Devices for the Out-patient Care

The Cabinet of Minister's Regulations No.626 Regulations Regarding Pricelist for Public Services Provided by the State Medicines Pricing and Reimbursement Agency

The Cabinet of Minister's Regulations No. 803 Regulation on medicinal products pricing principles

The Cabinet of Ministers Regulations No.167 Medical Product Advertising Procedure and Procedure Entitling a Manufacturer of Medicinal Products to Provide Free Samples of Medicinal Products to Physicians

 The Cabinet of Minister’s Regulations No.885 Classification procedure of medicinal products

The Cabinet of Minister's Regulations No. 919 Procedure of Monitoring of Adverse Drug Reactions

The Cabinet Regulations No 289 Procedures for Clinical Trials and Observational Studies of Administration of Medicinal Products, Marking of Investigational Medicines and Assessment of Conformity to Good Clinical Practice

The Cabinet of Minister's Regulation No. 436 Procedure of Import and Export of Medicinal Products 
Annex  1 - 5 (1,5 MB)

The Cabinet of Minister's Regulations No 57 Labelling procedure of medicinal products and requirements for the package leaflets

The Cabinet of Ministers Regulation No. 416 Order of Distribution and Quality Control of Medicinal Products