Pharma and medical devices

Russia: Amended list of regulated narcotics, psychotropic substances and their precursors

As of 1 January 2019, the list of controlled narcotics, psychotropic substances and their precursors has been amended. The list of such substances and their precursors was adopted by Decree No. 681 of 30 June 1998. As a result of the amendments, several substances were added to List I and II.

List I (prohibited narcotic substances) was supplemented by the following positions:

Russia: Adopted Regulation on issuing clinical trial permits

As of 21 April 2018, developers of pharmaceuticals (the Applicants) are required to follow the adopted procedure if they wish to obtain a permit for a clinical trial for their pharmaceuticals.

The state agency responsible for issuing clinical trial permits is the Ministry of Healthcare of the Russian Federation.

EAEU: Adopted unified Guideline for the quality of modified-release drugs

The adopted Guideline has been approved for the use by the authorized bodies of the EAEU member states.

 The Guideline applies to dosage forms in which the modification of the rate and (or) the place of release of the active ingredient (active substances) in a definite manner is compared with the standard release dosage forms.

Ukraine: Amended drug registration procedure

As of 24 November 2017, manufacturers and importers of pharmaceuticals (drugs) are required to comply with the revised drug registration requirements.

The amendments to the drug (pharmaceutical/medicine) registration procedure have been introduced by Order No. 1202 of 2 October 2017.