Manufacture drugs authorization are valid only in electronic form since January

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The issuance of authorizations for the drugs production, medical devices and medical activities since January 1, 2021 is possible only in the electronic version, Roszdravnadzor reports. The manufacturer will need to coordinate with regulators an entry in the authorization register, and paper documents do not have force.

“Since January 1, 2021, the Federal Law of December 27, 2019 No. 478-FL” On Amending Certain Legislative Acts of the Russian Federation regarding the Introduction of a Registry Model for the Provision of State Services for Authorization of Certain Activities “entered into force, according to the presence of a authorization is confirmed in the electronic version, and a record in the register of authorization”, the regulator said.

Also, since January 1, applications and sets of documents for import will be submitted through the Unified Portal of Public Services, as well as on the official website of Roszdravnadzor www.roszdravnadzor.gov.ru in the section “Electronic Services.”

 

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