Law Messenger. Life Sciences Alert. November 2017

Transcription

1 21 December 2017 Law Messenger Life Sciences Alert November 2017 EY s Russian Tax & Law practice was named a leading Tax firm in Russia in World Tax 2017, an annual guide published by the International Tax Review. In this issue: Special rules have been established for describing medicines for State procurement purposes Standard forms of checklists for use in scheduled inspections relating to the circulation of medicines have been approved Special rules have been established for maintaining registers of narcotic drugs and psychotropic substances in electronic form A procedure has been approved for marking biomedical cell products with radio-frequency identification tags Amendments have been made to the rules for granting subsidies for the conduct of clinical studies of medicinal drugs and clinical trials of medical devices and for the manufacture of medicines, pharmaceutical substances and medical devices

2 1. Government Decree No of 15 November 2017 Concerning Special Rules for the Description of Medicinal Products for Medical Use Which Are Procured to Meet State and Municipal Requirements This decree will come into force from 1 January The adoption of the decree is provided for in part 5 of Article 33 of the Federal Law Concerning the Contract System for Procurements of Goods, Work and Services to Meet State and Municipal Requirements, according to which the government has the right to establish special rules for the description of certain types of procurements. The decree introduces a number of requirements and restrictions for state customers with regard to the description of medicines which are to be procured. In particular, documentation for the procurement of a medicinal product must include, in addition to the details specified in the Federal Law Concerning the Contract System for Procurements of Goods, Work and Services to Meet State and Municipal Requirements, the dosage form and dosage strength of the product, with provision for it to be supplied as a multiple of a given dosage and in two dosage units, and the residual shelf life of the product. It is not permissible in describing a procurement item to specify: a) equivalent dosages of a medicinal product which require the splitting of the solid dosage form of the product b) a dosage of a medicinal product in particular units of measure where it is possible to convert to other units of measure (for example, IU (international unit) may be converted to mg, or per cent may be converted to mg/ml, etc.) c) the fill volume of the primary packaging of a medicinal product, with the exception of infusion solutions d) whether or not additives are contained in a product e) fixed temperature conditions for the storage of products where alternative conditions exist f) the form of presentation (primary packaging) of a medicinal product (e.g. ampoule, phial, blister pack, etc.) g) the number of units (tablets, ampoules) of a medicinal product, and a requirement to supply a specific number of packs rather than a quantity of the medicinal product h) requirements relating to pharmacodynamic and (or) pharmacokinetic indicators of a medicinal product i) other specifications of medicinal products which are contained in instructions for the use of the products, indicating the specific manufacturer of a medicinal product In exceptional cases, where there are no other ways of describing a medicinal product, a procurement description may include specifications referred to in items c) to i) above. In this case, the procurement documentation must contain an explanation of the need to include those specifications together with indicators needed to determine whether purchased medicinal products meet the established specifications, the maximum and (or) minimum values of those indicators and the values of indicators which cannot vary. It is permitted in describing a procurement item: in the case of products needed for prescription to a specific patient by decision of a medical panel, to specify trade names in the case of products prescribed for parental use, to specify the route of administration of the product in the case of products intended for use in paediatric care, to specify the child age In describing a procurement item: in the case of products in cartridges or other forms of presentation, a condition must be stated to the effect that they are supplied to patients free of charge together with the medicinal products in the case of combination products (combining 2 or more active ingredients) and sets of products, reference must be made to the possibility of supplying singlecomponent products 2

3 in the case of products for which requirements may be established for packaging them with a solution or device for diluting or administering them, reference must be made to the possibility of supplying individual components of that package in the case of products in the form of syringes/injection pens, reference must be made to the possibility of supplying them with an administration device which corresponds to the volume of the product to be administered (with certain exceptions) 2. Order No of the Federal Healthcare Supervision Service of 9 November 2017 Concerning Approval of the Forms of Checklists (Lists of Test Questions) to be Used by the Federal Healthcare Supervision Service and its Territorial Bodies in Conducting Scheduled Inspections as Part of Federal State Supervision in the Area of the Circulation of Medicines In accordance with governmental Decree No of 13 February 2017 Concerning Approval of General Requirements Relating to the Development and Approval of Checklists (Lists of Test Questions), the Order approves checklists that are to be used by the Federal Healthcare Supervision Service in conducting scheduled inspections relating to the circulation of medicines. The list includes questions touching on all mandatory requirements to which companies and entrepreneurs are subject and compliance with which is critical from the point of view of preventing danger to life and health. The checklists focus particularly on rules governing the storage, transportation and quality control of medicines. The document is currently in the process of being registered by the Justice Ministry and has been made available on the database for advance perusal pending the completion of registration. It should be pointed out that the text of the document may undergo changes in the process of being registered by the Justice Ministry. 3. Government Decree No of 10 November 2017 Concerning the Introduction of Amendments to Certain Acts of the Government of the Russian Federation on Matters Relating to the Circulation of Narcotic Drugs and Psychotropic Substances This decree entered into force on 23 November. According to the decree: it will be possible for registers of operations involving the circulation of narcotic drugs and psychotropic substances to be maintained in electronic form sheets of electronically maintained registers must be printed out, numbered and signed by a responsible person each month; when a calendar year ends, those sheets will make up the register an entry in electronically maintained registers must be certified by the enhanced qualified electronic signature of a responsible person The decree also approves a new version of the register of operations involving the circulation of narcotic drugs and psychotropic substances. 4. Order No of the Ministry of Industry and Trade of 20 October 2017 Concerning the Introduction of Amendments to the Administrative Regulations on the Provision by the Ministry of Industry and Trade of the Russian Federation of the State Service of Issuing a Document Which Confirms That a Medicinal Product for Medical Use Was Manufactured in Accordance with Good Manufacturing Practice Requirements and is to be Presented at the Request of an Authorized Body of a Country into Which the Medicinal Product is Imported, as Approved by Order No of the Ministry of Industry and Trade of the Russian Federation of 31 December 2015 Order No of the Ministry of Industry and Trade of 20 October 2017 Concerning the Introduction of Amendments to the Administrative Regulations of the Ministry of Industry 3

4 and Trade of the Russian Federation on the Provision of the State Service of Issuing a Document Containing Information on Stages of the Manufacture of a Medicine for Medical Use Which Are Carried Out in the Territory of the Eurasian Economic Union, as Approved by Order No of the Ministry of Industry and Trade of the Russian Federation of 31 December 2015 These orders make the following amendments to the Administrative Regulations in question with effect from 28 November 2017: the element bldg. 1 is added to the address of the Industry and Trade Ministry (including the postal address) the numbers of the Industry and Trade Ministry s telephone information lines have changed changes are made to the list of information to be posted on a provision is inserted to the effect that information on the procedure and timeframe for the provision of the state service is to be provided free of charge the list of regulatory acts governing relations arising in connection with the provision of the state service is extended to include documents governing the provision of state services in electronic form changes are made to indicators reflecting the quality and accessibility of the state service the duration of interaction between an applicant and representatives of the Industry and Trade Ministry for the purpose of the provision of the state service is reduced to 10 minutes the state service is not obtainable through a multifunctional centre administrative procedures may now be carried out electronically a section is added to the Administrative Regulations setting out the rules for carrying out administrative procedures electronically 5. Order No. 800n of the Health Ministry of 13 October 2017 Concerning Approval of the Procedure for Marking Primary and Secondary Packaging of Autologous Biomedical Cell Products and Combination Biomedical Cell Products Using Methods for the Radio-Frequency Identification of a Biomedical Cell Product as Belonging to a Specific Patient This order entered into force on 28 October. The Order requires a manufacturer of the specified types of biomedical cell products to place a radio-frequency identification tag on primary and secondary packaging. 6. Government Decree No of 30 Introduction of Amendments to the Rules for the Granting of Subsidies from the Federal Budget to Russian Organizations as Partial Compensation for Costs Associated with the Implementation of Projects Involving the Organization and Conduct of Clinical Studies of Medicinal Products Under the Development of Drug Manufacturing Subprogramme of the Development of the Pharmaceutical and Medical Industry State Programme of the Russian Federation for Government Decree No of 30 Introduction of Amendments to Decree No of the Government of the Russian Federation of 1 October 2015 Government Decree No of 30 Introduction of Amendments to the Rules for the Granting of Subsidies from the Federal Budget to Russian Organizations as Partial Compensation for Costs Associated with the Implementation of Projects Involving the Organization and Conduct of Clinical Trials of Implantable Medical Devices Under the Development of the Manufacturing of Medical Devices Subprogramme of the Development of the Pharmaceutical and Medical Industry State Programme of the Russian Federation for

5 Government Decree No of 30 Introduction of Amendments to the Rules for the Granting of Subsidies from the Federal Budget to Russian Organizations as Partial Compensation for Costs Associated with the Implementation of Projects Involving the Organization of the Manufacture of Medical Devices Under the Development of the Manufacturing of Medical Devices Subprogramme of the Development of the Pharmaceutical and Medical Industry State Programme of the Russian Federation for These government decrees amend the rules for granting subsidies for the conduct of clinical studies of medicinal products and implantable medical devices and for the manufacture of medicines, pharmaceutical substances and medical devices. In particular, additional requirements are established for recipients of subsidies. Subsidies may be granted to Russian companies which do not have debts to the budget. The company concerned must not be in the process of re-organization, liquidation or bankruptcy. No more than 50% of the participants in a company which receives subsidies must be registered in offshore zones. In addition, the recipient of a subsidy must not receive budget funds on the basis of other normative acts for purposes similar to the purpose of the subsidy. This has the effect of increasing the range of supporting documents which must be provided by subsidy recipients. Changes are also made to the rules for determining the maximum amount of subsidies to be granted. In some cases the requirement to repay the unused balance of a subsidy is excluded. The requirement to repay balances of subsidies which remain unused in the current year is eliminated. Authors: Andrey Glebashev Yakov Nikishin For additional information please contact the author of this publication: Andrey Glebashev Andrey.Glebashev@ru.ey.com 5

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