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Main  >  News  >  Roszdravnadzor powers in the field of inspection will comply with the EAEU rules

Roszdravnadzor powers in the field of inspection will comply with the EAEU rules

The Ministry of Health of Russia has developed amendments to the Regulation on the Federal Service for Surveillance in Healthcare, according to which the powers of Roszdravnadzor are established to conduct monitoring, carry out inspections, inspections of subjects of circulation of medical devices and medicines for medical use in accordance with the published regulatory documents of the EAEU in the field of good practices. The draft document was published on the regulation.gov.ru portal, its discussion will last until August 5, 2020.

According to the Monitoring Rules, monitoring includes the collection, registration, analysis of information about adverse events (incidents) and the adoption of appropriate decisions.

In accordance with the Rules of Good Clinical Practice, inspection is the act of a notified body to conduct a formal inspection of documents, infrastructure, records, quality assurance agreements and any other sources that are considered by the notified body to be relevant to research and which may be located at the research center, at the facilities of the sponsor and / or the contract research organization, or in other organizations that, in the opinion of the notified body, require inspection. Regulatory authorities are bodies that have the power to exercise regulatory functions.

According to the Rules of Good Pharmacovigilance Practice, the authorized bodies of the Member States are obliged to conduct pharmacovigilance inspections of marketing authorization holders or other organizations engaged by marketing authorization holders to fulfill their pharmacovigilance obligations.

The purpose of the Good Distribution Practice Guidelines is to maintain the proper storage, transport and distribution conditions necessary to ensure the quality, safety and efficacy of medicines throughout the supply chain and to prevent the risk of counterfeit medicines entering the supply chain.

According to Clause 7 of the Rules of Good Laboratory Practice, a test facility inspection is an on-site inspection of a laboratory's procedures and practices to assess compliance with the principles of good laboratory practice.

Clause 2 of decision No. 81 (Rules of Good Laboratory Practice) established that inspection of compliance with the Rules of Laboratory Practice is carried out within the framework of pharmaceutical inspections in accordance with the Rules for Pharmaceutical Inspections, approved by the decision of the Council of the Eurasian Economic Commission dated 03.11.2016 No. 83

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