EAEU: Adopted criteria for the inclusion of different versions of a modified medical product into one registration certificate
The Reference Book is to be included into the common system of regulatory and reference information of the EurAsian Economic Union.
The information included into the Reference Book is based on the lists of international non-proprietary names (INN Lists) published by the World Health Organisation.
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.
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.
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.
As of 15 May 2018, importers and manufacturers of veterinary medicines and feed additives are required to comply with the provisions of the adopted Technical Regulation (TR) on the Safety of Veterinary Medicines and Feed Additives.
The adopted TR applies to ready-to-use chemical-pharmaceutical and biological medicines and feed additives.
The Russian Federal Healthcare Supervision Service (RosZdravNadzor) published a letter clarifying how safety of medical oxygen cylinders is regulated.
All veterinary medicines for which a registration application was submitted before 27 November 2017, the instruction must contain information set out by the adopted Order.
Any instruction for a veterinary use of a medicine must contain information on:
- The name of the medicine;
As of 5 October 2017, the Ministry of Health of the Russian Federation (the Ministry) is appointed as a designated authority for registering medical preparations (pharmaceuticals) that are to be placed on the EurAsian Economic Union market.
The Ministry is also empowered to:
As of 20 August 2017, all organisations that apply for a pharmaceutical registration, must compile a dossier in accordance with the adopted revised requirements. The revised requirements were adopted by Order No. 409n dated 12 July 2017.
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