Detailed requirements on distribution of medicines containing codeine in small quantities.

02.05.2012

Legal Update No. 348

Goltsblat BLP advises of publication of Information Letter No. 25-1/10/2-4131 dated 23 April 2012 of the Russian Ministry of Health and Social Development concerning distribution of combination medicines containing codeine or its salts in small quantities (the Letter).

This Letter interprets the requirements of Resolution of the Russian Government No. 599 dated 20 July 2011 defining “codeine or its salts in small quantities”.

The following restrictions exist for all combination oral medicines containing codeine or its salts up to 20 mg per dose in solid dosage form or up to 200 mg per 100 millilitres /100 mg in liquid dosage form:

  • such medicines may not be posted, including internationally, or distributed as humanitarian aid (unless transported to specific constituent entities of the Russian Federation in an emergency and by decision of the Russian government);
  • such medicines are to be sold to individuals strictly by prescription.

No minimum level of codeine or its salts in medicines is thus determined and all medicines containing codeine and its salts are to be released by prescription only. If any medicines exceed the codeine limits specified in the Letter, the prohibitions and restrictions on distribution of narcotics and psychotropic substances will apply to them in full.

The Ministry also advises that medicines containing codeine and its salts in small quantities must be prescribed on Prescription Form No. 107-1/у and Prescription Form No. 148-1/у-88 (for prescribing drugs under special control, including psychotropic substances on List III, which covers narcotics, psychotropic substances and their precursors; potent and toxic substances; and other medicines recorded on an itemised and quantitative basis).

The Letter does not specify the prescription forms physicians should use or pharmacies accept for particular medicines. Furthermore, there are currently no regulatory requirements on recording drugs on an itemised and quantitative basis, which might complicate the process of recording and selling medicines containing codeine and its salts in small quantities.

For additional information, please contact:

to Nina Belozertseva
Head of Healthcare & Pharmaceuticals,
Goltsblat BLP
T: +7 (495) 287 44 44,
E: info@gblplaw.com

to Alexander Muravin
Assosiate,
Goltsblat BLP
T: +7 (495) 287 44 44,
E: info@gblplaw.com

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