KPMG Pharma Bulletin Issue #10, 2016 (October) | KPMG | RU
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KPMG Pharma Bulletin Issue #10, 2016 (October)

KPMG Pharma Bulletin Issue #10, 2016 (October)


Director, Head of Healthcare & Pharmaceuticals

KPMG in Russia


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Ministry for Industry and Trade proposed new restrictions for public procurement of drugs

Draft amendments to the Government Resolution #1289 dd. November 30, 2015 envisage the following changes:

- when purchasing Essential drugs, the state customer shall reject all the bids containing pharmaceuticals produced using non-Russian API;

- the API is considered as ‘made in Russia’ if the molecule synthesis had been performed in Russia;

- should there be only one bid containing pharmaceuticals, produced from API made in Russia, the state customer shall unconditionally accept this bid. Should there be several such bids, a tender shall be conducted;

- shall there be no submitted bids for pharmaceuticals produced from APIs made in Russia, the ‘odd man out’ rule shall apply. I.e., if there are two or more suppliers offering pharmaceuticals produced as a finished dosage form n Russia or in the EEU states, all the bids containing foreign-origin drugs shall be rejected.

The exclusive preference for pharmaceuticals produced from APIs made in Russia is supposed to be in effect during 2 years.


Ministry of Healthcare to develop the procedure for pricing of a contract with a sole pharmaceutical supplier

The Ministry of Healthcare announces development of the Government Resolution "On the Procedure for Determining the Initial (Maximum) Price of the Contract Concluded with a Sole Supplier (Contractor, Executor) in Course of Pharmaceuticals Procurement".

According to the web-portal of the Federal draft laws and regulations, the the draft resolution development is driven by creation of info-analytical system for monitoring and control over pharmaceuticals procurement for public needs.

The document is expected to come into force in March 2017.


Ministry of Healthcare proposes simplified registration of generic drugs

The Ministry of Healthcare has developed a draft Federal Law "On Amendments to Article 18 of the Federal law "On Circulation of Pharmaceuticals".

The amendments permits using the information on the results of pharmaceuticals pre-clinical and clinical trials during the state registration of generic drugs without the consent of the owner of the rights for the reference pharmaceutical, provided that such information is publicly available and placed in the open data sources, in particularly, in special professional media or in the web.

Public debated on the document are open till December 29, 2016.


Roszdravnadzor lists the criteria to be assessed during audits of pharmaceuticals and medical devices circulation compliance

The Federal Service on Surveillance for Healthcare and Social Development (Roszdravnadzor) prepared the lists of regulations containing mandatory requirements, which observance is assessed in course of monitoring/audits of compliance in areas of pharmaceuticals and medical devices circulation, licensing of pharmaceutical and medical activities, pharmacovigilance etc.

The lists were prepared in accordance with Section IV "Systemizing and updating of mandatory requirements, which compliance is assessed during regulatory control actions, including clearance of obsolete, redundant and excessive mandatory requirements" of the action plan on control and supervisory activities improvement in the Russian Federation for 2016-2017 (approved by the Government’s Resolution #559-p dd. April 01, 2016).

The public debates of the list of regulations are open till December 12, 2016.

The 26 lists of requirements are available at the web-site of Roszdravnadzor.


Ministry of Healthcare approved the application form on registration dossier amendment

The Ministry of Healthcare has approved the application form on introducing amendments to documents included into a registration dossier for the registered pharmaceuticals. The respective Departmental Order # 727n dd. September 21, 2016 was registered on October 07, 2016 by the Ministry of Justice.

The form shall be used for the applications submitted to the Ministry of Healthcare after the Order enters into force.


Requirements to patient manuals are approved

On October 07, 2016, the Ministry of Justice registered the Order # 724n of the Ministry of Healthcare "On Approval of requirements to patient manuals for pharmaceuticals" dd. September 21, 2016.

The requirements extend to the patient manuals for pharmaceuticals submitted for state registration after the Order’s enactment.


Ministry of Healthcare developed guidelines for good practice of biomedical cellular products circulation

The Russian Ministry of Healthcare placed for public debates the draft Departmental Order "On Approval of Good Practice Rules for Circulating Cellular Biomedical Products (CBMP)", setting out:

- general requirements for pre-clinical research, manufacturing and quality control of CBMP,

- quality requirements to biological material and donor cellular lines, used as raw materials,
- risk management procedures, rules for effectiveness assessment, general and special requirements to staff and consultants;

- requirements for engineering, locating and constructing of premises and facilities used in CBMP manufacturing and quality control cycle.

Medical devices

The list of implantable medical devices extended

The Russian Government has approved the new versions of the List of medical devices implanted into a human body, and the List of medical devices delivered under prescription in scope of social aid provision. The Prime Minister has signed the corresponding Decree #2229-r dd. October 22, 2016.

− The list of medical devices implanted into a human body is extended by adding 160 types of medical devices. 3 medical devices types which are non-implantable, as per the currently effective classification, are delisted;

− The list of medical devices delivered under prescription in scope of social aid provision was supplemented by 2 items ("Glucose reagent for in vitro diagnostic purposes", "tip pen for blood lancet").


Draft Law on goods labeling is developed

The Ministry of Finance has developed the draft Federal Law "On Goods Labeling with Control (Identification) Marks in the Russian Federation".
The document applies to legal relations in the following areas:

- creation and use of control marks for labeling products circulating in the Russian Federation,

- circulation of goods subject to mandatory labeling by control marks and the state control over their circulation,

- development and functioning of systems on voluntary labeling of goods by control marks.

The previous Pharma Bulletin issues are accessible our site.

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