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Academic Journal
Recommendations on the procedure for determining the interchangeability of medicinal products
B. K. Romanov, N. D. Bunyatyan, Yu. V. Olefir, V. P. Bondarev, A. B. Prokofyev, R. I. Yagudina, R. N. Alyautdin, E. L. Kovaleva, A. P. Pereverzev, K. E. Zatolochina, A. S. Kazakov, A. V. Komratov, E. Yu. Pasternak
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 3-8 (2018)
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| Title | Recommendations on the procedure for determining the interchangeability of medicinal products |
|---|---|
| Authors | B. K. Romanov, N. D. Bunyatyan, Yu. V. Olefir, V. P. Bondarev, A. B. Prokofyev, R. I. Yagudina, R. N. Alyautdin, E. L. Kovaleva, A. P. Pereverzev, K. E. Zatolochina, A. S. Kazakov, A. V. Komratov, E. Yu. Pasternak |
| Publication Year |
2018
|
| Source |
Регуляторные исследования и экспертиза лекарственных средств, Vol 0, Iss 2, Pp 3-8 (2018)
|
| Description |
The authors developed and presented recommendations on the procedure for determining the interchangeability of medicinal products. Interchangeability of drugs determined at the state registration of the medicinal product or when amendments to the documents contained in the registration dossier for already medicinal product. Recommended by the authors of the sequence of procedures for determining the interchangeability of drugs includes four successive stages. The conformity assessment of generic medicinal product reference drug proposed by six parameters specified in the Federal Law N 429-FZ, in sequence («Аlgorithm for the assessment of interchangeability»).
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| Document Type |
article
|
| Language |
Russian
|
| Publisher Information |
Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’), 2018.
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| Subject Terms | |
