Publications

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.

The decisions of the Eurasian Economic Union Commission (EEC) came into effect on 26 April 2017, in particular, those approving the Nomenclature of Dosage Forms, Rules for Maintaining the Nomenclature of Medical Products, Rules for Determining the Category of Medicines Sold with and without a Prescription, and Rules for Monitoring the Safety, Quality and Efficiency of Medical Products.

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.