KPMG Pharma Bulletin Issue #10, 2017 (October)
KPMG Pharma Bulletin Issue #10, 2017 (October)
The Prime Minister signed the decree approving the List of Essential Drugs for 2018. The list was expanded by adding 60 drugs and 8 new dosage forms, including those for the cancer, cardiovascular diseases treatment and others. In addition, 25 items were added to the list of medicines for patients entitled to social benefits.
The Russian Government has submitted to the State Duma the draft law enabling pharmacies, including veterinary ones, to sell non-prescription pharmaceuticals remotely.
Online sale of Rx drugs remains prohibited.
It is also proposed to adjust the scope of powers of the federal executive authorities governing pharmaceuticals circulation. In particular, it is suggested that access is restricted to websites containing information on online drugs sale, instead of their pre-trial shut-down.
The Prime Minister signed the Resolution # 1207 dd. 04.10.2017, changing the Rules for Granting Subsidies to Russian Companies for Partial Reimbursement of Expenses under Projects for Innovative Pharmaceuticals Development.
According to the amendments, subsidies are available to Russian companies, meeting the following requirements as at the first day of the month preceding the month of the planned subsidy agreement signing:
− having no payables for taxes, social contributions, fines and other fiscal obligations according to the currently effective Russian tax legislation;
− having no overdue obligations to repay to the federal budget subsidies and investments granted in accordance with other legal acts;
− not being under re-organization, liquidation or bankruptcy procedure.
In addition, the list of documents to be submitted to the Ministry for Industry and Trade for entering a subsidy agreement is amended and expanded.
The Russian Federal Anti-Trust Service issued clarifications on determining the remaining shelf-life of pharmaceuticals by public/municipal customers in the procurement documentation.
According thereto, the residual shelf-life stated in a public purchase order shall be defined as a specific period (e.g., in years, months, days) or as a specific date by which the pharmaceutical retains its usability.
The Moscow Duma approved in the first reading the Draft Law "On Amendments to Certain Laws of the City of Moscow in Area of Taxation", which exempts the companies incorporated in the Cluster of property tax and transport tax, starting from January 1, 2018 and for the period of 10 years.
The Ministry of Healthcare posted for public debates the draft departmental Order "On Approval of Rules for Carrying out Clinical Laboratory Research".
The draft decree is aimed at organizing activities of medical and other institutions conducting clinical laboratory research and their departments and subdivisions, establishes staffing and equipping standards.
The Prime Minister signed the Resolution # 1286 dd. 23 October 2017, approving the amendments to the Statute on the Federal State Supervision in Area of Pharmaceuticals Circulation. In particular, it is proposed to introduce the risk-based approach in the field of veterinary pharmaceuticals circulation.
The Resolution sets out criteria for classifying the items subject to state supervision per specific risk categories and the frequency of state inspections based on the risk category assigned.
In accordance with the Order of the Ministry of Healthcare of Russia # 621н dd. 08.09.2017, certain Administrative Regulations of Roszdravnadzor are expanded. Particularly, the procedure is established for requesting and obtaining documents and information necessary for conducting state audits and available with the federal authorities, under intra-institutional information exchange procedures.
Roszdravnadzor is empowered to control and supervise the regional authorities with respect to completeness and quality of executing the powers specified in part 1 of Article 15 of the Federal Law # 323-FZ "On the Fundamentals of Protection Public Healthcare in the Russian Federation". For that purpose, the following Administrative Regulations were amended:
− On executing licensing control over medical equipment production and technical maintenance activities, approved by the Order of the Ministry of Healthcare of Russia # 953н dd. December 30, 2014;
− On performance of the state function on executing the license control over medical activities, approved by the Order of the Ministry of Healthcare of Russia # 454н dd. July 17, 2015;
− On executing licensing control over activities on narcotic pharmaceuticals circulation, psychotropic substances and their precursors, narcotic plants cultivation, approved by the Order of the Ministry of Healthcare of Russia # 285н dd. May 05 2016;
− On control over medical devices circulation, approved by the Order of the Ministry of Healthcare of Russia # 196н dd. April 05, 2013.
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