We bring to your attention the next digest of legal regulation of regulation of Russian pharmaceutical industry for December 2018, prepared by the Law Firm “BRACE”.
Among the main changes is new legal status to clinical recommendations, which are planned to be completely revised in time to December 31, 2021.
We bring to your attention the next digest of legal regulation of procurement in Russian legislation for December 2018, prepared by the Law Firm “BRACE”
Amendments to the Federal Law of April 05, 2013 N 44-FZ “On the contract system in the field of procurement of goods, works, services for state and municipal needs” were approved. The changes relate to...
1. Amendments to the Rules of state registration of medical devices.
Resolution of the Government of the Russian Federation of May 31, 2018 No. 633 “On Amendments to the Rules for the State Registration of Medical Products”
This resolution expanded the list of documents are to be submitted for state registration of a medical product. In an application for state registration of...
The rules for determining the requirements for procurements of federal state bodies, government bodies of state extrabudgetary funds of the Russian Federation, their territorial bodies and state and state institutions subordinate to them, federal state unitary enterprises to certain types of goods, works and services approved by Government Decree of 02 September 2015 N 927 extend to the most...
For the member states of the Eurasian Economic Union, criteria were made for the procedure for classifying products as medical product products, which are planned to be applied from 2019.
We are glad to inform you that the Law Firm “BRACE” opens two new areas of activity within the framework of the practice “Healthcare and pharmaceutics”, namely “Registration of medical devices” and “Amendments to the registration documents of medical devices”.
Within the framework of both directions, both a full cycle of services in the field of registration of medical devices, as...