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Legislation

Pharmaceutical Law

The Cabinet of Minister's Regulations No.376 Medicinal Product Registration Procedure 
Annex 1 - 9

The Cabinet of Minister's Regulations No.873 State Agency of Medicines Publicly Available Paid Service Price List

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.744 Pricelist for Public Services Provided by The National Health Service

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

Cabinet Regulations No.378 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

Regulation of the Cabinet of Ministers No. 47 Pharmacovigilance procedures

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 

Cabinet of Ministers Regulation No.344 Procedures for importing and distribution of active substances

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