FAQ
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Which organization is responsible for issuing a GMP certificate?
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For medicines for human use - MINPROMTORG (http://minpromtorg.gov.ru/), for European countries - the European Inspection Body (Group of inspectors of the PIC / S organization). For veterinary medicines - ROSSELKHOZNADZOR (http://www.fsvps.ru/)
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Who performs inspections of production plants?
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Production plants for medicinal products for human use - the inspection team of SID and GP (https://gilsinp.ru/), for medicinal products for veterinary use - FSFI VGNKI (http://www.vgnki.ru)
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Can the Russian regulatory body carry out a specific GMP inspection for the production plant?
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The inspection is carried out in accordance with the list of products requested for inspection. That is, it is specific by product. However, when submitting the application with the inspection list, the manufacturer can include all manufactured products. And in this way the inspection will cover all the productive activities of the plant.
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Who can submit the request for inspection?
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In the Russian Federation the application is submitted by production plant- If it is a foreign manufacturer, it can be done by an authorized applicant or the production plant directly.
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Is it possible to request a change in the registration dossier for consideration by the Ministry of Health of the Russian Federation before the inspection is completed and a GMP certificate is obtained?
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Yes.
