Life sciences
Alerts
15January2015
Important amendments have been made to the Law on Circulation of Medicines
Pepeliaev Group advises that on 22 December 2014 the Russian President signed Law No. 429-FZ “On amending Federal Law 'On Circulation of Medicines'” (the “Law”). On 23 December 2014 this Law was published on the official online legal information portal (www.pravo.gov.ru).
03June2014
The Russian Ministry of Economic Development has set the conditions for foreign goods to be admitted to take part in state and municipal procurement.
Pepeliaev Group advises that on 1 June 2014, Order No.155 of the Ministry of Economic Development dated 25 March 2014 ‘On the conditions for releasing goods originating from foreign states for the purposes of purchasing goods, work and services to meet state and municipal needs’ (the Conditions) has entered into force.
17March2014
An administrative regulation has been approved for the Russian Ministry of industry and trade to perform the state function of licensing control over the manufacturing of medicines for medical use
Pepeliaev Group advises that on 3 March 2014 the Russian Ministry of Justice registered Order No. 1607 of the Russian Ministry of Industry and Trade dated 4 October 2013 "On approving the Administrative Regulation for the Russian Ministry of Industry and Trade to perform the state function of licensing control over the manufacturing of medicines for medical use" (the "Regulation").
04March2014
Requirements have been approved for healthcare organisations which conduct clinical trials of medical products
For the attention of: heads of healthcare organizations which conduct clinical trials of medical products as well as R&D and registration units of producers/distributors of medical products.
15January2014
The Federal Service for Surveillance in Healthcare (Roszdravnadzor) has published the recommended form for giving notice of events organised (sponsored) by pharmaceutical companies
Pepeliaev Group advises that the Federal Service for Surveillance in Healthcare (Roszdravnadzor) has issued Letter No. 16I-1595/13 “On informing Roszdravnadzor about holding scientific or other events” (the “Letter”).
18December2013
Rules have been adopted to create a list of medicines to be purchased under their trade name
Pepeliaev Group advises that on 28 November 2013 the Russian Government approved, through Order No. 1086, Rules to create a list of medicines to be purchased under their trade name (the “Rules”). These Rules determine the procedure for medicines to be included in the relevant list (the “List”).
18December2013
Rules have been established for companies to communicate with health care and pharmaceuticals professionals as have rules for holding events financed by companies. Liability has been introduced for a number of violations in the sphere of public health
Pepeliaev Group advises that on 25 November 2013 the President signed Law No. 317-FZ “On amending certain pieces of legislation of the Russian Federation and repealing certain provisions of Russian legislative acts regarding the protection of public health in the Russian Federation”.
13December2012
Amendment to the Methodology for manufacturers of medicines to set maximum sale prices for medicines
Amendments have been made to the Methodology for manufacturers of medicines to set maximum sale prices for medicines included in the list of vital and essential medicines approved by Order No. 961n/527a of the Russian Ministry of Health and Social Development and the Federal Tariffs Service dated 3 November 2010.
09July2012
Public service connected with licensing pharmaceutical activity
Pepeliaev Group advises that on 6 February 2012 the Russian Ministry of Public Health and Social Development published a draft order on its website by which it approved the Administrative Regulations of the Federal Supervisor for Public Health with regard to provision of a public service connected with licensing pharmaceutical activity.
20April2012
Roszdravnadzor has approved Administrative Regulation on pre-clinical and clinical trials conduct monitoring
Pepeliaev Group advises that the Ministry of Healthcare and Social Development of RF issued Order No. 1091n dated 09/29/2011 “On adoption of Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) Administrative Regulation regarding the performance of state controlling function over medicines pre-clinical trials and medications for medical usage clinical trials”, which came into effect on the 1st of April, 2012.