GOOD DISTRIBUTION PRACTICE: MODERNISATION OF THE MEDICINES DISTRIBUTION SYSTEM IN RUSSIA
https://doi.org/10.30895/1991-2919-2018-8-1-36-43
Abstract
The article describes the main stages of introduction of the Good Distribution Practice (GDP) in Russia following the adoption of new laws making it mandatory for wholesalers to comply with requirements for storage and transportation of medicinal products. The article compares the regulatory requirements of the European Union, Eurasian Economic Commission and the Russian Federation for GDP system development by entities involved in medicines circulation. It highlights the main activities that help a wholesaler create an efficient GDP system. The key role in the implementation of GDP principles is played by the director of the company and the employee in charge. The article analyses the risk-oriented approach that the Federal Service for Surveillance in Healthcare relies upon when supervising wholesalers of medicinal products. It was demonstrated that the compliance of a product with efficacy and safety criteria can only be assured if GDP standards are met.
About the Author
E. V. Yakovleva
Limited Liability Company «AstraZeneca Pharmaceuticals»
Russian Federation
Russian Federation
Ekaterina V. Yakovleva - Specialist on Quality and Certification of Medicinal Products.
3/1 Begovaya street, Moscow 125284, Russian Federation
References
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4. Balashov AI. «Inadequate Production Practice»: Modernization of the Quality Assurance System for the Production of Medicines in Russia. News of Higher Educational Institutions 2014; (1): 72-7 (In Russ.)
Review
For citations:
Yakovleva E.V. GOOD DISTRIBUTION PRACTICE: MODERNISATION OF THE MEDICINES DISTRIBUTION SYSTEM IN RUSSIA. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2018;8(1):36-43. (In Russ.) https://doi.org/10.30895/1991-2919-2018-8-1-36-43
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