The Ministry of Healthcare has placed for public debates the following drafts of departmental orders:
The Administrative regulations envisage:
Furthermore, the Regulations limit the duration of quality control procedures by 40 business days from the receipt by the expert of pharmaceuticals samples, standard samples and documents. In exceptional cases, the timeframe may be extended, but not more than for 30 business days.
Deputies submitted to the State Duma a draft Federal Law ‘On Amending Article 80 of the Federal Law "On Fundamentals of Public Healthсare Protection in Russia’, which proposes to abolish the state registration of prices for medical devices implanted into a human body and those used for fixation (temporary or permanent), delivery, extraction of implant devices, adhesion prevention, including devices used when preparing to implantation. Most of such medical devices are auxiliary and have a short life-cycle.
In addition, the draft law clarifies the rules of setting maximum wholesale and retail trade mark-ups to actual prices for medical devices implanted into a human body within under the programme of state guarantees for free medical aid to citizens.
Additional requirements for medical devices circulated within the EEC were enacted by the EEC Council Resolution #27 dd. February 12, 2016 “On Approval of General Safety and Efficacy Criteria for Medical Devices, Requirements to their Labeling and Operational Documentation”. In accordance with the Resolution, medical devices shall be designed and manufactured in a way ensuring that they are safe for the patient and other persons when used as intended and based on the technical knowledge, experience, education or special training, considering the patient’s clinical and physical condition, assuming an acceptable risk as compared to the therapeutic effect for the patient.
The General criteria include also requirements to for labeling and operational documentation for medical devices circulating within the EEC.
In accordance with the EEC Council Resolution #26 dd. February 12, 2016 “On Special Label for Medical Devices Circulating in the EEC Market”, medical devices registered under the EEC rules and verified for compliance with the General Safety and Efficacy Criteria, shall be marked with a special market circulation mark.
Labeling of medical devices with the special market circulation mark shall be done by the manufacturer or its authorized representative before releasing of a medical device into circulation in the EEC territory.
The EEC Council Resolution # 28 dd. February 12, 2016 approved the Rules for technical trials of medical devices for assessment of compliance with the General Safety and Efficacy Criteria, as well as to requirements to their labeling and operational documentation.
Technical trials are performed by institutions, entities and enterprises entitled to carry out medical devices trials for registration purposes, based on applications of medical devices manufacturers or their representatives.
The trials are carried out in order to assess the compliance of medical devices with the General Safety and Efficacy Criteria, as well as compliance with the labeling and operational documentation requirements.
The trials are performed by institutions, entities and enterprises listed in the unified register of authorized entities, based on applications of medical devices manufacturers or their representatives.
The Law-drafting Commission has approved the Draft Federal Law “On Amendments to the Code of Administrative Offences of the Russian Federation in Part of Improving Administrative Liability in Healthcare Area”.
The draft proposes establishing administrative liability for violations detected by the Federal Service on Healthcare Surveillance (Roszdravnadzor) in course of control over the quality of the work of medical and pharmaceutical companies, including violations of:
Furthermore, the draft law proposes treating the following breaches as a separate administrative offense:
In addition, the draft law proposes increasing fines for violation of rules for pharmaceuticals sale, including selling Rx drugs without a doctor’s prescription.
The Federal Anti-Monopoly Service of Russia prepared a draft Government Order on approval of an action plan (road map) on “Development of Fair Competition in Healthcare Area”, which includes the following activities:
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector
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