pharmaceutical regulation
Russian Laws

The new Amendments of July 2019 to
Federal Law 61
"On circulation of medicines"

The legal document below was translated into Russian by CEG or a translation company on behalf of CEG.
This translation may contain inaccuracies. For all issues related to law enforcement practice, please contact the authorities of Russia / the EAEU and CEG company.
These amendments have not yet entered into force.
GOVERNMENT
OF THE RUSSIAN FEDERATION
to
STATE DUMA OF THE FEDERAL ASSEMBLY
OF THE RUSSIAN FEDERATION

On the submission of the draft federal law "On Amendments to the Federal Law" On the Circulation of Medicinal Products" and to the Federal Law" On Amendments to the Federal Law "On the Circulation of Medicinal Products" regarding the improvement of the procedure for determining the interchangeability of medicinal products for human use"
July 2, 2019
No. 5973п-П12
MOSCOW
In accordance with Article 104 of the Constitution of the Russian Federation, the Government of the Russian Federation submits for consideration by the State Duma of the Federal Assembly of the Russian Federation the draft federal law "On Amendments to the Federal Law" On the Circulation of Medicinal Products" and to the Federal Law" On Amendments to the Federal Law "On the Circulation of Medicinal Products" regarding the improvement of the procedure for determining the interchangeability of medicinal products for human use".

Attachment:
1. Draft federal law on 35 sheets.
2. Explanatory note to the draft law on 4 sheets.
3. The financial and economic justification on 1 sheet.
4. The list of federal laws subject to invalidation, suspension, amendment or adoption in connection with the draft law, on 1 sheet.
5. The list of regulatory legal acts of the President of the Russian Federation, the Government of the Russian Federation and federal executive bodies subject to invalidation, suspension, amendment or adoption in connection with the draft law, on 13 sheets.
6. An order of the Government of the Russian Federation on submission of the draft law to the State Duma of the Federal Assembly of the Russian Federation and on the appointment of an official representative of the Government of the Russian Federation for consideration of the draft law by the Chambers of the Federal Assembly of the Russian Federation, on 1 sheet.

Chairman of the of the Russian Federation /signature/ D. Medvedev
FEDERAL LAW
On Amendments to the Federal Law "On the Circulation of Medicinal Products" and the Federal Law "On Amendments to the Federal Law "On the Circulation of Medicinal Products" regarding the improvement of the procedure for determining the interchangeability of medicinal products for human use"
Draft law
No. 745128-7
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