Guidelines for the selection of trade names of medicines and for manufacturing of finished dosage forms in the Eurasian Economic Union
The Board of the Eurasian Economic Commission (EEC) approved on 29 January 2019 the Recommendations on the Guidelines for the Selection of Trade Names of Medicinal Products and the Guidelines for Manufacturing of Finished Dosage Forms of Medicinal Products in order to eliminate differences in the requirements for the manufacturing of finished dosage forms of medicines in Eurasian Member States Economic Union (EAEU).
Changes in the regulation of medicines circulation in Russia in 2019
This review highlights some significant changes in federal laws and other regulatory legal acts in Russia that regulate the circulation of medicines.
Changes in the procedure for admission of foreign medical devices and medicines to public procurement in Russia
On 1 January 2019, amendments to the Resolution of the Government of the Russian Federation No. 102 of 05.02.2015 that provides for restrictions and conditions for the admission of certain types of medical devices originating from foreign countries for the purpose of procurement for state and municipal needs ("Resolution No. 102") and the Resolution of the Government of the Russian Federation dated November 30, 2015 No. 1289 that establishes the restrictions and conditions for admission for the purposes of procurement to ensure the state and municipal needs of medicinal products originating from foreign countries included in the list of vital and essential drugs (VED) ("Resolution No. 1289"), came into force.
Registration of Medical Devices in Russia: Recent Changes
The Government of the Russian Federation by its Resolution No. 633, dated 31 May 2018 introduced changes to the Rules for the State Registration of Medical Devices approved by Resolution of the Government No. 1416, dated 27 December 2012 (hereinafter - the 'Registration Rules').
Simplification of the procedure for state registration of medicines in Russia
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.
New support measures for manufacturers of medicinal products in Russia
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.
Registration of medicines in the Eurasian Economic Union
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.
Marking and monitoring of medicines circulation in Russia from 2020
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.
Draft law on the remote retail trade in medicines 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.
Regulation in the telehealthcare sector in Russia
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.
Russia ratifies the protocol on compulsory licensing of medicines production
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.