KPMG Pharma Bulletin, Issue #6, 2015 (June)
KPMG Pharma Bulletin, Issue #6, 2015 (June)
In this issue:
Pharmaceuticals
- More information to be requested when registering an orphan pharmaceutical
- Ministry of Healthcare approved the rules for radio-pharmaceuticals production
- Ministry of Healthcare to take necessary actions on providing pharmaceuticals to subsidized persons
- Ministry of Healthcare developed the procedure with for pharmaceuticals side effects reporting
- Rules developed for assessing the influence of additives on a pharmaceutical safety
- Ministry of Healthcare is preparing amendments to the Assessment procedure of authorized representatives of pharmaceutical manufacturers
- Action Plan on development and production of advanced immuno-biological pharmaceuticals adopted
- Essential Drugs purchase prices will be published at the Ministry of Healthcare website
Medical devices
Other
Pharmaceuticals
More information to be requested when registering an orphan pharmaceutical
The Ministry of Healthcare placed for public debates the draft text of the Order “On Establishing the Volume of Information to be Provided for Development of Clinical Documentation Section in course of an Orphan Pharmaceutical State Registration”.
According to the document, to develop the clinical documentation section when applying for state registration of an orphan pharmaceutical, the reports on the results of clinical research of a pharmaceutical for medical use must be submitted, in particular:
- reports on bioavailability research, researches reporting the correlation of results obtained in vitro and in vivo;
- reports on pharmacokinetic researches;
- reports on pharmacodynamics researches;
- reports on clinical researches of effectiveness and safety;
- report on post-registration experience (if available).
Ministry of Healthcare approved the rules for radio-pharmaceuticals production
The Ministry of Healthcare Order #211n of April 27, 2015 regulates the the radio-pharmaceuticals production in medical institutions, namely:
- radio-pharmaceuticals production for a patient shall be performed under a written application of an authorized employee of a medical institution in accordance with the doctor’s prescription;
- radio-pharmaceuticals production in medical institutions shall be performed in controlled areas (indoor spaces) complying with sanitary epidemiological and hygienic standards for radiation security provision;
- a medical institution shall approve the documentation on production and quality assurance of radio-pharmaceuticals, setting out consistently (by stages) the manufacturing technology of such pharmaceuticals with account to the corresponding pharmacopoeial items requirements and the general pharmacopoeial items;
- etc.
The document is expected to enter into force starting from January 1, 2016.
Ministry of Healthcare to take necessary actions on providing pharmaceuticals to subsidized persons
The Ministry of Healthcare, the Ministry for Industry and Trade and the Ministry of Finance in cooperation with senior government officials of Russian constituent entities have been ordered by the President to take the necessary actions to:
− provide certain categories of citizens who are eligible for preferential provision of pharmaceuticals with pharmaceuticals in accordance with the laws of Russia;
− provide the Russian citizens with pharmaceuticals and medical devices procured under the program on free medical aid provision.
The deadline for the Order fulfillment is June 16, 2015 and onwards on a quarterly basis.
Ministry of Healthcare developed the procedure with for pharmaceuticals side effects reporting
The Ministry of Healthcare has placed for public debates the Draft Departmental Order “On Establishing the Procedure for Reception, Recording, Processing, Analysis and Keeping of the Reports Received from the Subjects of Pharmaceuticals Circulation and Public Authorities on Side Effects and Reactions, Serious and Unforeseen Side Reactions when Applying a Pharmaceutical, on Intercourse Particularities with Other Pharmaceuticals, Idiosyncrasy, and on Other Facts and Conditions Constituting a Danger to Life or Health of a Human or Animal, or Influencing the Expected Utility to Potential Risk Ratio of Applying a Pharmaceutical by the Registration Certificates Holders and Owners, Legal Entities Admitted to Clinical Trial Conduction within the Russian Federation”.
Should any serious side reactions when taking a pharmaceutical, on intercourse particularities with other pharmaceuticals, idiosyncrasy, and on other facts and conditions influencing the expected utility to potential risk ratio when applying a pharmaceutical be identified, legal entities acting as holders or owners of registration certificates, or other authorized entities shall take measures to eliminate the negative implications of applying such pharmaceuticals, prevent the harm infliction to life or health of a human or animal, protect the letter from applying such pharmaceuticals and shall also perform additional data collection on the pharmaceutical’s effectiveness and safety.
Rules developed for assessing the influence of additives on a pharmaceutical safety
The Ministry of Healthcare has placed for public debates the Draft Departmental Order “On Establishing Rules for Studies to Prove Absence of Diverse Influence of Additives on the Safety and (or) Effectiveness of a Pharmaceutical for Medical Use”.
A new additive means any inactive ingredient and (or) element forming a part of a pharmaceutical which is:
- not supposed to impact the therapeutic effect in the dosage proposed;
- not supported by data on safety regarding the proposed effect, treatment duration or way of medical administration.
Per functional type, additives are classified into: fillers, diluents, dissolvents, moisturizers, emulsifiers, preservatives, flavor additives, absorbents, colourants, matrix for sustained release.
Ministry of Healthcare is preparing amendments to the Assessment procedure of authorized representatives of pharmaceutical manufacturers
The Ministry of Healthcare notified on the development of the Departmental Order “On Amendments to the Assessment Procedure of Pharmaceutical Manufacturers’ Authorized Representatives”.
According to the legislators’ information, the document is aimed at bringing the current regulatory standards of drugs circulation related to the assessment procedures for pharmaceutical manufacturers’ authorized representatives in compliance with the educational requirements of the Federal Law #313-FZ of October 22, 2014.
Action Plan on development and production of advanced immuno-biological pharmaceuticals adopted
The Government has adopted the Action Plan on Development and Production of Advanced Immuno-biological Pharmaceuticals for Medical Use.
The Plan includes variety of measures on developing incentive mechanisms for immuno-biological pharmaceuticals production in Russia with account taken of the public demand, which includes the national calendar of prophylactic immunization and the calendar of prophylactic immunization upon epidemic indications.
The Plan is aimed at:
- initiating research and technological development in area of advanced immuno-biological pharmaceuticals development;
- improving immuno-biological pharmaceuticals nomenclature with account taken of the forecasted public demand;
- technical re-tooling and modernization of the Russian immuno-biological pharmaceuticals manufacturers;
- providing incentives for immuno-biological pharmaceuticals production in Russia at all stages of the technological process;
- improving the federal state educational standards and programs for the purpose of educating the specialists having advanced knowledge, skills, experience and expertise in the area of immuno-biological pharmaceuticals circulation.
Essential Drugs purchase prices will be published at the Ministry of Healthcare website
Medical devices
The Draft Law on improving taxation of medical devices for vision correction
The Legislative Government Commission has approved the Draft Federal Law “On Adoption of Amendments to Clause 2 of Article 149 of the Tax Code”, intended to improve the taxation of medical devices for vision correction, in particular, glasses, lenses and glasses frames.
Sales of glasses (except sunglasses), lenses and glasses frames (except sunglasses frames) is currently VAT-exempt according to the Clause 2 of Article 149 of the Russian Tax Code.
The current wording of the Clause does not allow clearly determine the correctness of VAT exemption for glasses and lenses with reduced light transmission in case when such goods have two functions, i.e. sun protection and vision correction.
In accordance with the above, it is proposed to exempt from VAT the sales of glasses and lenses for vision correction irrespective of whether they are sun-protective.
Other
Professional standard for pharmaceutical experts developed by the Ministry of Labour
The Ministry of Labour has placed for public debates the Draft Departmental Order “On Establishing the Professional Standard “Expert in Pharmaceutical Activities”.
The document provides for the description of labour functions and activities necessary for an expert in pharmaceutical activities.
The Law On International Medical Cluster in Skolkovo adopted by Federation Council
On June 24, 2015 the Federation Council of Russia adopted the Law envisaging the establishment of an international medical cluster in Skolkovo.
The Law provides the possibility to provide medical treatment to patients under the obligatory medical insurance (OMI) program within the Cluster territory. Medical assistance financed from the state budget and the OMI funds can be performed only for those Cluster participants who possessthe permissive documentation issued in the Russian Federation.
The technologies and pharmaceuticals originating from foreign states will be permitted for use in the Cluster territory provided that they are not only registered in the said foreign states, but are practically applied there. To ensure achievement of the set goals, special legal regimes will be introduced in the Cluster for healthcare, pharmaceuticals circulation, urban planning, licensing, technical regulation, electric-power supply, education, sanitary and epidemiological compliance activities.
According to the document, simplified requirements and special implementation provisions are set for the Cluster development. In particular, Russian and foreign companies and individual investors may take part in the project. However, the range of foreign participants is limited to OECD member states only (including Germany, Israel, Switzerland and the USA). The Cluster will be managed by a specialized Russian company set up under the resolution of the Moscow City Government. At the same time, no tax incentives are envisaged by the document.
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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