On 14 February 2014, Rossiyskaya Gazeta, the official edition of the Russian Government, published Order No. 300n of the Russian Ministry of Healthcare dated 16 May 2013 “On approving the requirements for healthcare organisations which conduct clinical trials of medical products, and the procedure for establishing whether the healthcare organisations comply with these requirements” (the “Order”). This order entered into effect on the 25th of February.Russia-map-colour
Summary of the main changes
The Order sets out several requirements for healthcare organisations which conduct clinical trials of medical products and clinical trials for in vitro diagnostics. In addition, the instrument also determines the procedure for establishing whether a healthcare organisation complies with these requirements for the purposes of being officially declared competent and authorised to conduct clinical trials of medical products within the class of medical aid offered.
The Order actually introduces an additional licensing procedure, along with the existing procedures for licensing healthcare activities. Now, a healthcare organisation which conducts clinical trials of medical products must possess, in addition to a licence, a permit for clinical trials…
[read more…]
Acknowledgements: Pepeliaev Group