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Life Science Alert archive

2014

  • April - The Order, which entered into force on 4 May 2014, approves the Procedure of carrying out the compliance assessment of medical devices in the form of technical examination, toxicological examination, clinical trials for the purposes of their state registration.
  • February-March - The Order, which entered into force on 14 February 2014, approves Requirements of medical organizations carrying out clinical trials of medical devices and Procedure for establishing the compliance with such requirements.

2013

  • December 2013 – January 2014 – The Federal Law of the Russian Federation “On Amendments to Certain Legislative Acts of the Russian Federation” entered into force on 1 January 2014.
  • November – The Federal Law, which was adopted on 15 November 2013, introduces amendments to the Federal Law “On the Circulation of Medicines” and the Code of Administrative Offenses.
  • October – The Resolution, which entered into force on 29 October 2013, prolongs the deadline for changing the registration certificates for medical devices and medical equipment.
  • September – The Order, which approves the Rules on organization of production and quality control of pharmaceuticals, has been adopted.
  • August – The latest regulatory news in Life Science industry in Russia.
  • July – The Ministry of Health plans to extend the deadline for replacing registration certificates for medical devices.
  • June – On 15 June 2013 the Resolution of 03 June 201 No. 469 “On Approval of the Regulations on Licensing of Medical Equipment’s Production and Technical Maintenance (excluding a case when technical maintenance is carried out for legal entities’ and sole proprietors’ personal use)” came into force.
  • May – The Resolution, which was adopted on 03 June 2013, establishes new procedure of licensing of medical equipment’s production and technical maintenance.
  • April – Roszdravnadzor informs about the necessity to re-issue licenses, which have been issued before the effective date of the Federal Law of 4 May 2011 No. 99-FZ “On Licensing of Certain Types of Activities”, on the activities, the titles of which have been changed.
  • February-March – The Order, which entered into force on 31 March 2013, approves the Administrative regulation on provision of the state service of issuance of permits to import pharmaceuticals for execution of pharmaceuticals’ expertise, conduct of clinical trials or provision of medical aid to the specific patient.

2012

  • November – Russian Government Resolution of 12 November 2012 No. 1152 approves the Regulations on the state control over the quality and safety of medical activity.
  • October – Russian Federation Government Resolution of 4 October 2012 No. 1006 approves the Rules specifying the procedure and conditions for provision of paid medical services by medical organizations to citizens.
  • 26 September – The Ministry of Health has presented the draft amendments to the methodology on the determination by producers of pharmaceuticals of the maximum supply prices on pharmaceuticals included in the Essential drug list.
  • September – Russian Federation Government Resolution of 10 September 2012 No. 904 approves the Rules specifying the procedure for formation of the list of medical organizations which provide high-technology medical care at the expense of budgetary allocations.
  • August – According to the Minutes on accession of the Russian Federation to the WTO, which entered into force on 22 August 2012, import tariffs and customs duties for different goods will be decreased starting from 2013
  • July – The Federal law, which came into force on 23 July 2012, specifies the procedure for placing orders for supply of pharmaceuticals for the state and municipal needs
  • June – Russian Federation Government Resolution of 19 June 2012 No. 615 approves the Rules of keeping the state register of medical devices and organizations engaged in production and manufacture of medical devices
  • May – Russian Federation Government Resolution of 2 May 2012 No. 413 “On Amending Certain Acts of the Russian Federation Government”
  • April – Russian Government Resolution of 16 April 2012 No. 291 "On Licensing of Medical Activity"
  • March – The Federal Antimonopoly Service of Russia has drafted amendments to the Federal Law of 12 April 2010 No. 61-FZ "On Circulation of Pharmaceuticals". Learn more.
  • February – The Order, which entered into force on 19 February 2012, approves the nomenclature of medical services, according to which standards of medical care shall be developed.

2011

  • November 2011 – January 2012 – Russian Federation Government Executive Order, which entered into force on 7 December 2011, approves the essential drugs list (EDL) for the year 2012.
  • October – The RF State Duma adopted at third reading the Draft Law on general principles of health care with regard to the citizens in the RF.
  • September – Draft Directive of the Russian Federation Government of 23 September 2011 “On Approval of the List of Essential Drugs for the Year 2012”.
  • August - Amendments to the Order "On Approval of the Minimal Range of Pharmaceuticals for Medical Use Required for Medical Aid".
  • July - The Ministry of Justice of the Russian Federation registered the Order, which limits the number of customs authorities entitled to perform customs clearance of pharmaceutical products classified in product items 3002, 3003, 3004 TN VED TS.
  • June – Russian Federation Government Resolution, which amends certain acts of the RF Government, in particular, the Rules on Import of Pharmaceuticals for Medical Use, came into force.
  • May – President signed the new Federal law “On Licensing of Certain Types of Activities”.
  • April – The Order, which sets out the rules for approval of interested-party transactions involving a public state-financed institution of the city of Moscow under the authority of the Moscow Healthcare Department, entered into force.
  • 26 April – Special issue: amendments to the Law on Public Procurement are enacted.
  • March – Our first issue of the Life Science Alert covers the latest legislave acts and regulations in pharmaceuticals, healthcare and medical technology.

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