Life sciences

New good pharmacy practice for medicines intended for human use Law firm Pepeliaev Group advises that, on 9 January 2017, the Russian Ministry of Justice registered Order No. 647n of the Russian Ministry of Healthcare “On approving Good Pharmacy Practice for medicines intended for human use” dated 31 August 2016 (“GPP”).

Restrictions on admitting new types of medical devices to state and municipal procurement Pepeliaev Group advises that on 30 November 2016 Resolution No. 1268 of the Russian Government was signed “On amending the list of individual types of medical devices originating in foreign countries the admission of which is restricted for the purposes of procurement for state and municipal needs” (the “Resolution”).

Regulatory changes for trade in products containing GMOs Pepeliaev Group advises that, on 3 July, the Russian President signed Federal Law No. 358-FZ “On amending certain items of the legislation of the Russian Federation to enhance the state regulation of genetic engineering”. 

Code of good-faith practices in the pharmaceutical sector Pepeliaev Group advises that 19 April 2016 will see the adoption, under the auspices of the Association of European Business's Healthcare and Pharmaceuticals Committee, of a Code for Good-faith Practices in the Pharmaceutical Sector. 

Software being classified as medical devices Pepeliaev Group advises that the Federal Service on Surveillance in Healthcare (known in Russia by the abbreviation 'Roszdravnadzor') has issued explanations concerning the registration of software as medical devices ('Explanations').

The procedure has come into force for registering manufacturers' prices for medical devices that are implanted in a human organism Law firm Pepeliaev Group advises that rules have been established for the state regulation of prices for medical devices which have been included in the list of medical devices that are implanted in a human organism when medical care is provided under the state programme guaranteeing that free medical care will be provided to the public.

Russian Government Sets Restrictions on and Conditions for Medicines Which Are on the List of Vital and Essential Medicines to Be Admitted for Public Procurement Pepeliaev Group advises that, on 10 December 2015, a Resolution of the Russian Government (the 'Resolution') will take effect that sets restrictions on and conditions for the medicines which are on the list of vital and essential medicines to be admitted for the purposes of state and municipal procurement. 

From 1 October, new rules have been in force for registering (re-registering) the maximum selling prices of medicines included in the List of Vital and Essential Medicines Pepeliaev Group advises that the Russian Government has adopted a Resolution (the "Resolution") which has amended the rules for registering and re-registering the maximum selling prices for manufacturers of medicines included in the List of Vital and Essential Medicines ("VEM"). The Resolution also provides for a new method for calculating such prices .

The Resolution came into effect on 1 October 2015. 

State regulation of prices has been introduced for certain types of medical devices Pepeliaev Group offers a brief overview of Federal Law No. 33-FZ1 (the “Law”) dated 8 March 2015, which establishes state regulation of prices for medical devices which have been included in the list of medical devices that are implanted in a human body when medical care is provided in the context of the programme of state guarantees of providing medical care to citizens free of charge. 

Restrictions have been set in terms of admitting certain categories of medical devices to state and municipal procurement processes

Restrictions have been set in terms of admitting certain categories of medical devices to state and municipal procurement processes Pepeliaev Group advises that Resolution No. 102 of the Russian Government “On restricting the admission of certain categories of medical devices originating in foreign countries for the purposes of procurement for state and municipal needs” dated 5 February 2015 (the “Resolution”) was published on 6 February 2015 on the official legal information portal (www.pravo.gov.ru).

Changes in rules for retail sales of medical devices