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Changes in the rules for organizing and conducting GMP inspections of drug manufacturers will be introduced

The Ministry of Industry and Trade of Russia has prepared changes to the Rules for organizing and conducting inspections of drug manufacturers for compliance with the requirements of good manufacturing practice rules, as well as issuing opinions on the compliance of a drug manufacturer with these requirements. The document is published on the portal.
According to the published information, the draft resolution was developed in order to harmonize the provisions of the legislation of the Russian Federation in the field of drug circulation in terms of confirming the compliance of drug manufacturers with the requirements of good manufacturing practice rules of the Eurasian Economic Union and resolving the issues of inspecting drug manufacturers for medical use, referred by legislative acts of Eurasian economic union as national legislation.

The draft resolution amends the Rules for organizing and conducting inspections of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice, as well as issuing conclusions on the compliance of a drug manufacturer with these requirements, approved by the Decree of the Government of the Russian Federation No. 1314 of December 3, 2015 means “The requirements for the rules of good manufacturing practice" in part of establishing mechanism for providing by foreign manufacturers of medicines (its authorized representative) of a corrective and preventive action plan (CAPA) and a report on its implementation to an authorized institution, with the goal of being able to eliminate the identified inconsistencies before sending the inspection report to the authorized body to make a decision on issuing (refusing issue) GMP findings.

According to the draft resolution, in case of detection of inconsistencies during the inspection, the foreign manufacturer (his authorized representative) prepares a plan of corrective and preventive actions and a report on its implementation within 30 calendar days from the date of the inspection report. The authorized institution considers the plan of corrective and preventive measures and a report on its implementation and within 30 calendar days from the date of its receipt from a foreign manufacturer of medicinal products (its authorized representative) sends an inspection report on the results of reviewing the plan of corrective and preventive actions and a report on its implementation the authorized body and the foreign manufacturer of medicines (his authorized representative).

According to the draft resolution, in the event of inconsistencies in the inspection, the foreign manufacturer (his authorized representative) prepares a plan of corrective and preventive actions and a report on its implementation within 30 calendar days (previously - 10 calendar days) from the date of the inspection report. The authorized institution considers the plan of corrective and preventive measures and a report on its implementation and within 30 calendar days from the date of its receipt from a foreign manufacturer of medicinal products (its authorized representative) sends an inspection report on the results of reviewing the plan of corrective and preventive actions and a report on its implementation the authorized body and the foreign manufacturer of medicines (his authorized representative).

Also, the draft resolution provides for a change in the date of issuance of the conclusion on the compliance of the drug manufacturer with the requirements of the rules of good manufacturing practice (hereinafter - the conclusion) up to 30 calendar days from the date of signing the inspection report; additional grounds for refusal to issue a conclusion in the event that the manufacturer of a medicinal product evades the conclusion of an inspection agreement with an authorized institution; and also the paragraph on the maximum inspection period is deemed invalid.

The draft resolution complies with the provisions of the Treaty on the Eurasian Economic Union of May 29, 2014, the Agreement on common principles and rules for the circulation of medicines within the Eurasian Economic Union of December 23, 2014. The decision of the Council of the Eurasian Economic Commission of November 03, 2016 No. 83 On approval of the “Rules for conducting pharmaceutical inspections ”and other international treaties of the Russian Federation.

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