Life sciences

The coming week has been declared a non-working week in Russia: is this true for everyone?

Pepeliaev Group advises that the Decree on the Non-Working Week from 30 March to 3 April may be inapplicable to certain representatives of pharmaceutical companies.

New criteria for classifying software as medical devices

Pepeliaev Group advises that the Russian Federal Service for Surveillance in Healthcare (“Roszdravnadzor”) has issued information letter No. 02I-297/20 “On software” dated 13 February 2020, and that information letter No. 01I-2358/15 “On registering software” dated 31 December 2015, which was previously in effect, has been revoked. 

The rules of mandatory medical insurance have changed considerably Pepeliaev Group advises that the new Rules of mandatory medical insurance approved by Order No. 108n of the Russian Ministry of Health dated 28 February 2018 have come into force. 

The status of clinical guidelines is changing Pepeliaev Group advises that the President of the Russian Federation has signed Federal Law No. 489-FZ dated 25 December 2018, which significantly changes the status of clinical guidelines.

The procedure has been approved for organising and providing medical assistance using telemedicine Pepeliaev Group advises that the Russian Ministry of Healthcare has approved Order No. 965n “On approving the procedure for organising and providing medical assistance using telemedicine technologies” dated 30 November 2017 (the “Procedure”). 

The procedure for providing advice on issues regarding the procedures relating to the state registration of medical devices

Pepeliaev Group advises that a new document has been adopted in the area of the state registration of medical devices

New rules for public procurement of polyvinyl-chloride plastic single-use medical devices (PVC SUD)

Pepeliaev Group advises that two Governmental Resolutions have been signed that are significantly changing how public procurement of PVC SUD is carried out.

Telemedicine technologies have been legalised for usage in healthcare

Pepeliaev Group advises of the adoption of Federal Law No. 242-FZ “On amending certain legislative acts of the Russian Federation regarding the application of information technologies in healthcare” dated 29 July 2017 (the “Law on Telemedicine”). 

The common market for medicines and medical devices will start functioning in the near future Pepeliaev Group advises that the Kyrgyz Republic has ratified the protocols of accession of the Republic of Armenia* to the Agreement on common principles and rules of circulation of medicines in the Eurasian Economic Union (EAEU)** and the Agreement on common principles
and rules of circulation of medical products (medical devices and medical equipment) in the EAEU***.

Requirements have been adopted for the contents of the manufacturer’s technical and operating documentation in the registration dossier of a medical device Pepeliaev Group advises that a new legal regulation has been adopted for the state registration of medical devices

Amounts of state duties for the registration of medicines for human use and medical devices and the procedures for paying such duties have been established across the Eurasian Economic Union. Pepeliaev Group advises that the amounts and payment procedures have been established with respect to state duties to be paid for the registration by authorised agencies of medicines for human use and medical devices across the Eurasian Economic Union (EAEU)*.

New good practice for the storage and transportation of medicines intended for human use Law firm Pepeliaev Group advises that on 9 January 2017 the Russian Ministry of Justice registered Order No. 646n of the Russian Ministry of Healthcare “On approving the Good Practice for the Storage and Transportation of Medicines Intended for Human Use” dated 31 August 2016 (“GPST”).