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