Russian and foreign legislation on regulation of post approval variations in the dossier for the medicinal products

Yu. V. Olefir; V. A. Merkulov; E. A. Soloviev; E. A. Ustyugova; L. V. Sayapina; V. P. Bondarev

Regulatory Research and Medicine Evaluation
Regulyatornye issledovaniya i ekspertiza lekarstvennykh sredstv

ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)

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Olefir Yu.V., Merkulov V.A., Soloviev E.A., Ustyugova E.A., Sayapina L.V., Bondarev V.P. Russian and foreign legislation on regulation of post approval variations in the dossier for the medicinal products. The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products. 2015;(4):11-15. (In Russ.)

This work is licensed under a Creative Commons Attribution 4.0 License.

ISSN 3034-3062 (Print)
ISSN 3034-3453 (Online)

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Valentina V. Kosenko

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About the Authors

Yu. V. Olefir
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

V. A. Merkulov
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

E. A. Soloviev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

E. A. Ustyugova
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

L. V. Sayapina
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

V. P. Bondarev
Federal State Budgetary Institution «Scientific Centre for Expert Evaluation of Medicinal Products» of the Ministry of Health of the Russian Federation
Russian Federation

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