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Experts of the GEROPHARM Group certified as Authorized Persons of Medicine Manufacturers by the Russian Ministry of Health

12 January 2015

According to the licensing procedure and Law FZ-61 on the Medicine Market, pharmaceutical companies must have Authorized Persons of Medicine Manufacturers, trained and certified by the Russian Ministry of Health. The requirement is important for manufacturing companies when a medicine is brought to market, the Authorized Person of the manufacturer ensures that the medicine complies with the requirements laid down during its state registration and that it is manufactured in accordance with medicine production and quality control regulations.

The GEROPHARM Group, as one of the leading national manufacturers of medicines, abides by this requirement. To date, three specialists have been trained and certified by the Ministry of Health: they are Ms. Natalia Novichkova, Quality Assurance Director at GEROPHARM, Ms. Natalia Kosareva, Deputy Quality Assurance Director at GEROPHARM-Bio, and Aleftina Gordeeva, Head of Quality Control and Head of the Test and Analytical Laboratory.

The corresponding Order no. 952 was signed by Minister of Health V.I. Skvortsova on December 29, 2014. The list includes 38 specialists.

When certifying the specialists, their theoretical knowledge and practical skills needed to discharge their professional duties of Authorized Persons were evaluated. The certification procedure normally includes an expert review of the report on professional activity of the medicine manufacturer’s employee, knowledge tests, and an interview.

Certification of authorized persons is done once every five years by the Attestation Committee of the Ministry of Health of the Russian Federation. The Certification Committee is formed by the Department of State Regulation of the Medicine Market of the Russian Ministry of Health.

See the Order at http://www.pharmvestnik.ru/images/files/735/mzrf_952_29_12_14.pdf

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