Russia

Policy

The Ministry of Health plays an important role in the regulation of Traditional Medicines, though they are not the enforcing authority. Laws and regulations regarding manufacturing, marketing and distribution of Traditional and Complementary Medicines were published in 1993, to be followed by its full implementation. The National Research Institute of T/CM  was established in the early 1990's at the same time when the National Policy was drafted. There are over 250 botanicals registered with related monographs.

Contact

The Ministry of Health may be able to refer interested parties to their  preferred vendors. Assistance can also be obtained from private consultants as listed below:

Consult Business Group (Pharminform Ltd. and Medinform Ltd) - consulting company assisting in registration.

Russian association of BAS and food supplements manufacturers.

 

Laws & Regulations

In Russia, dietary supplements are considered 'Biologically Active Substances' and require registration through a process that is expensive, complex and constantly changing.  Compliance with all requirements does not guarantee acceptance into the market, especially if the manufacturer does not have a partner that is incorporated in Russia.  Manufacturing guidelines are strict, and manufacturers are required to  comply   according to the  pharmacopoeia and state monographs.  The GMP for dietary supplements is as strict as GMP for pharmaceuticals and often with stricter guidelines including those for botanicals which must demonstrate clearance of radioactive testing.  Products may be sold with health claims and structure function claims.

There is a post-marketing surveillance program in place, as well as an adverse events reporting program to ensure consumers' safety.

The Ministry of Health plays an important role in the regulation of Traditional Medicines, though they are not the enforcing authority. Laws and regulations regarding manufacturing, marketing and distribution of Traditional and Complementary Medicines were published in 1993, to be followed by its full implementation.  The National Research Institute of T/CM was established in the early 1990's at the same time when the National Policy was drafted.  There are over 250 botanicals registered with related monographs.

Contact

The Ministry of Health may be able to refer interested parties to their preferred vendors. Assistance can also be obtained from private consultants as listed below:

Consult Business Group (Pharminform Ltd. and Medinform Ltd) - consulting company assisting in registration
127015 Moscow
ul Bolshaya Novodmitrovskaya 14, building 2, 3 floor
tel.:   + 7 495 797 4963
fax:   + 7 495 730 2482
e-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.
URL: www.c-b-g.ru 

 

Russian association of BAS and food supplements manufacturers:

URL: www.assoc-bad.ru