Russia defines objectives for control over circulation of biomed cell products

Print 13 October 2017
GMP News

Russian Prime Minister Dmitry Medvedev signed a Decree defining the objectives for state control over the circulation of biomedical cell products, including prevention, detection, and suppression of violations of laws governing the circulation of biomedical cell products.

The Decree establishes that the state control will be conducted by Roszdravnadzor and its regional offices in the form of scheduled and unscheduled documentary and on-site inspections in accordance with the Federal law “On Protection of Rights of Legal Entities and Individual Entrepreneurs in the Exercise of State Control (Supervision) and Municipal Control.”

It provides for inspections of compliance of the subjects of circulation of biomedical cell products with the requirements for preclinical studies, clinical trials, manufacturing, sale, storage, transportation, import into Russia, export from Russia, use, and destruction of biomedical cell products.

The adopted decision will allow to ensure the prevention, detection, and suppression of violations of laws governing the circulation of biomedical cell products.

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