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Laws in Russia and the Eurasian Economic Union

There are a lot of laws, rules, acts, orders governing drugs, food supplements, cosmetics, biological cell products and medical devices in Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan.
Here you can find the most impornant of them - we translated them into English for your convenience.
Hope this will be helpful!
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RUSSIAN LAWS / DRUGS
Federal Law 61 "On circulation of medicines"
This is a key Russian Law on drugs / medicinal products for human and veterinary uses.
RUSSIAN LAWS / DRUGS
Order 409n "On approval of the procedure for forming the registration dossier of a medicinal product..."
It includes Russian requirements for drugs' registration dossiers, the rules for the most important documents of the dossiers and special cases.
RUSSIAN LAWS / DRUGS
Order 959n "On approval of the classification of changes to be introduced to the documents contained in the Registration Dossier..."
It includes classification of changes to the documents contained in the Registration Dossier for a registered medicinal product for human use.
RUSSIAN LAWS / DRUGS
New Amendments to Federal Law 61 "On circulation of medicines"
Amendments of July 2019 (Draft Law 745128-7). They contain new and update terms, new Articles about Interchangeability of drugs, Pharmacovigilance Information and Fixing of the maximum wholesale and retail markup on the actual selling prices.
RUSSIAN LAWS / DRUGS
Order 58n "On approval of regulations for import... of a specific batch of authorized and (or) unauthorized medicinal products..."
It describes administrative procedure for receiving Ministry of Health's permission for import of specific batches of drugs to Russia.
RUSSIAN LAWS / DRUGS
Recommendations for obtaining permission to import a specific batch of unauthorized drugs into Russia
They cover the import for the purpose of R&D, clinical trials, drug registration, and quality control.
RUSSIAN LAWS / DRUGS / CLINICAL TRIALS
National Standard GOST R 57679-2017 of Russia "Bioequivalence Study of Medicinal Products"
This standard aims to optimize the design, performance and evaluation of bioequivalence (BE) studies of immediate release dosage forms of drugs in Russia. The BE concept serves as a basis for the procedures of state registration of generic medicinal products. Also they are frequently required when changes to the Marketing Authorization of an authorized medicinal product are made.