出版物

On 17 May 2018, amendments to the Federal Law 'On the Circulation of Medicines' (hereinafter - the 'Draft Law'), which simplify the procedure for registration of medicinal products for foreign manufacturers of medicines, were adopted in the third final reading.

Resolution of the Government of the Russian Federation No. 572 dated 12 May 2018 introduced amendments to Resolution No. 1289 dated 30 November 2015 that establishes restrictions and conditions for admission to the procurement for state and municipal need of medicinal products included in the list vital and essential medicines (VEM) originating from foreign states.

At the Pharmaceutical Forum of the EAEU and CIS countries held in Moscow in late February 2018, the Director of the Department of Technical Regulation and Accreditation of the Eurasian Economic Commission (EEС) said that the full-scale work on registration of medicines using the unified information system of the Eurasian Economic Union (EAEU) will start upon its launch scheduled on the first half of 2018. Currently, the integration segment of this system is ready, and the work to prepare national segments in each state of the EAEU is underway.

Pursuant to the changes in the Federal Law 'On Circulation of Medicines' introduced by Federal Law No. 425-FZ, dated 28 December 2017 ('Law No. 425-FZ'), from 1 January 2020 the federal state information system for monitoring the circulation of medicines for medical use from the manufacturer to the end user with the application of identification marks (system for monitoring the medicines circulation) will start functioning in Russia.

On 13 December 2017, the State Duma of the Russian Federation adopted in the first reading the draft Federal Law aimed at the legalisation of remote retail trade in medicines. The right to conduct remote retail trade (including trade via the Internet) in the OTC medicines for medical and veterinary use shall be granted to pharmacy organisations and veterinary pharmacy organisations, respectively.

The Federal Law No. 242-FZ dated 29 July 2017 amended certain legislative acts of the Russian Federation on the use of information technologies in the area of health care providing, in particular, for features of medial aid using telehealthcare technologies, e-document flow in the medial aid provision and the establishment of the Unified State Information System in the healthcare sector.

On 19 July 2017, the Federation Council approved a draft law on the Adoption of a Protocol on Amending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) under which TRIPS is supplemented with the provisions regarding the extended application of the mechanism allowing WTO member states to issue compulsory licenses for the production of generic medicines for export and, where required, to use immunity if their actions are challenged by other WTO member states.

In March and April 2017 the following regulatory acts entered into force:

--the Administrative Regulations of the Federal Service for Surveillance in the Health Care Sector (Roszdravnadzor) on Performance of Federal State Surveillance in the Area of Medicines Circulation through the Organisation and Conduct of Inspection for Compliance by Medicines Circulation Entities with the Requirements for Pre-Clinical Trials, Clinical Trials of Medicines, Storage, Transportation, Release, Sale of Medicines, Application and Destruction of Medicines

On February 10, 2017, the President of the Republic of Azerbaijan signed a decree on “additional measures with respect to the improvement of food safety system in the Republic of Azerbaijan” (“Decree”).

The Decree of the Government of the Russian Federation No. 37 dated 20 January 2017 amended the Rules for Granting Subsidies from the Federal Budget to Russian Organisations for Partial Compensation of Costs Incurred for the Implementation of Projects on the Arrangement and Conducting of Clinical Trials of Implantable Medical Devices within the Sub-Program 'Development of the Medical Devices Production" of under the State Program 'Development of the Pharmaceutical and Medical Industry' for 2013-2020 approved by the Decree No. 1046 of the Government dated 1 October 2015.

The Decree of the Government of the Russian Federation No. 1581 dated 31 December 2016 amended the list of medical goods, the sale and import of which in the territory of the Russian Federation and other territories under its jurisdiction are not subject to (exempted from) the value added tax.