Guidelines for the Preparation of a Document Containing the Drug Safety Monitoring Results
Abstract
Recommendations for the Marketing Authorisation Holders for the preparation of the document containing the results of the monitoring of safety of the drug, which is presented as part of the dossier at the state registration confirmation in 5 years after the initial registration of the drug in Russia are given. Links to legal documents, and specific examples of the proper execution of the relevant sections of the document are represented.
About the Authors
Yu. V. Olefir
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
B. K. Romanov
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
R. N. Alyautdin
Scientific Centre for Expert Evaluation of Medicinal Products
Russian Federation
Russian Federation
S. V. Glagolev
Federal Service for Surveillance in Healthcare of the Russian Federation
Russian Federation
Russian Federation
References
1. Federal law «On circulation of medicines» ¹ 61-FZ, 22.12.2014 (in Russian).
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6. Snegireva II, Zatolochina KE, Ozeretskovsky NA, Romanov BK, Mironov AN. Vaccine pharmacovigilance in Russia, legal and regulatory framework, current stage of development. Scientific Centre for Expert Evaluation of Medicinal Products Bulletin 2014; 4: 27–31.
7. Romanov BK, Glagolev SV, Polivanov VA, Leonova MV. Monitoring of drug safety. Safety and Risk of Pharmacotherapy 2014; 3: 11–14.
Review
For citations:
Olefir Yu.V., Romanov B.K., Alyautdin R.N., Glagolev S.V. Guidelines for the Preparation of a Document Containing the Drug Safety Monitoring Results. Safety and Risk of Pharmacotherapy. 2016;(3):14-21. (In Russ.)
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