In this issue:
- Authorities responsible for GMP compliance of Russian are appointed
- Pharmaceuticals exports from Russia have been suspended
- The Ministry for Industry and Trade drafted amendments to Pharma-2020 Program
- Federal Antimonopoly Service clarifies new rules for medical services advertising
- The Ministry for Economic Development proposed state procurement preferences for suppliers from the Customs Union
- The membership of the Commission for certification of an authorized representative of a pharmaceuticals manufacturer approved
- The Ministry of Health of Russia prepared procedure for medical products compliance assessment for registration purposes
- Amendments proposed to Federal Law FZ-61 and the Tax Code
Authorities responsible for GMP compliance of Russian are appointed
In accordance with the Federal law “On Circulation of Pharmaceuticals”, effective 1 January 2014 Russian pharmaceuticals companies should manufacture products in accordance with international GMP standards. To ensure a smooth and effective transition, control bodies equipped with professional staff are required.
The Ministry for Industry and Trade has set up a new Department for the Development of the Pharmaceuticals and Medical Industry with a section responsible for the licensing of pharmaceuticals production. It will exercise inspectorate functions, verify compliance with GMP rules and issue certificates of compliance.
At present, the Ministry for Industry and Trade is working on the issue of conducting inspections of foreign production facilities from the perspective of compliance with the new rules and is preparing proposals on respective amendments to the legislative and regulatory acts. Applications for the opinion certifying the GMP compliance along with the supporting documents (including for the manufacturers located outside Russia) should be submitted to the Ministry for Industry and Trade.
Pharmaceuticals exports from Russia have been suspended
The Association of Russian Pharmaceuticals Manufacturers (ARPM) has reported that effective 1 January the Federal Service for Surveillance in Healthcare and Social Development (Roszdravnadzor) stopped accepting documents for the drafting of Certificates of Pharmaceutical Products (CPP).
The CPP, which is required for the export of Russian pharmaceuticals and contains (in particular, information on inspections of pharmaceuticals production facilities), is issued for each batch of pharmaceuticals exported from Russia and is requested by most importer countries. Earlier, CCP had been issued by Roszdravnadzor, but effective 1 January 2014, Russian pharmaceuticals manufacturers are required to comply with international quality standards – Good Manufacturing Practice (GMP), and the Ministry for Industry and Trade should confirm compliance with these standards. Roszdravnadzor has not been vested with the authority to audit pharmaceuticals manufacturers and consequently may not issue CPP.
Deputy Prime Minister Arkady Dvorkovich stated that the Russian Government might vest both the Ministry of Industry and Trade and Roszdravnadzor with the authority to issue CPP.
According to the Deputy Prime Minister, it is highly likely that this authority will be transferred to the Ministry of Industry and Trade, considering its anticipated new functions in the area of GMP compliance control (see also the first topic above).
The Ministry for Industry and Trade drafted amendments to Pharma-2020 Program
The Ministry for Industry and Trade has prepared a draft of the Resolution of the Government of Russia “On Amendments to the Federal Special-Purpose Program “Development of the Pharmaceuticals and Medical Industry of Russia to 2020 and for Further Perspective””.
The draft Resolution specifies the financing to be allocated for the Program. The draft should granulate the Program’s activities, benchmarks and targets, based on the monitoring of the KPIs and goals achievement in 2013 and in context of the reduction in the Program financing from the federal budget.
To optimize deadlines for the R&D activities and the effectiveness of implementing the activity “Organization and Performance of Clinical Studies of Innovation Pharmaceuticals”, there are plans to increase the project implementation deadline to four years. The total amount of finance available for this activity from the federal budget will come to RUB 251.2 million (as per the price levels of corresponding years).
Federal Antimonopoly Service clarifies new rules for medical services advertising
In connection with the enactment on 1 January 2014 of the Federal Law No. 317-FZ, the Federal Antimonopoly Service of Russia clarifies that, according to part 8 of Article 24 of the Federal Law “On Advertising”, effective from this date medical services may not be advertised other than at medical or pharmaceuticals exhibitions, seminars, conferences and other similar events or in special printed media intended for healthcare and pharmaceuticals professionals.
At the same time, in accordance with clause 22 of the Resolution No. 58 of the Plenum of the Supreme Arbitration Court dated 8 October 2010 “On Certain Issues Arising from the Practical Application of the Federal Law ‘On Advertising’ by Arbitration Courts”, the definition of “medical activities” is broader than “medical services”.
Accordingly, the requirements of part 8 of Article 24 of the Federal Law “On Advertising” do not apply to the advertising of medical activities (such as, for example, stomatology, psychiatry, ophthalmology, etc.), which do not contain any references to specific medical services.
The Ministry for Economic Development proposed state procurement preferences for suppliers from the Customs Union
The Ministry for Economic Development of Russia has prepared a draft order on preferential access of certain goods manufactured in the Customs Union member states, in particular pharmaceuticals products, to the state procurements. The draft has been posted on the unified portal for the legal information disclosure. It was drafted in line with the law on the federal contract system that entered into force from 1 January and is assumed to remain in force until 31 December 2015.
Pursuant to the draft, participants in state procurement offering these categories of goods of Russian, Belarusian or Kazakhstani origin will be granted preferences of 15% in respect of the contract price. In other words, companies offering products manufactured in the Customs Union will be able to win in a state procurement even if their prices are 15% higher than those proposed by other tender participants.
An application to participate in the state procurement (conducted in the form of a tender or a request for quotation) containing a proposal on the supply of foreign goods is assessed based on the price criterion with a 15% mark-up factor. If several participants offer identical terms for the contract fulfillment with account of the preference, the contract will be concluded with the participant entitled to the preference.
The membership of the Commission for certification of an authorized representative of a pharmaceuticals manufacturer approved
Order No. 1063 of the Ministry of Healthcare of Russia dated 24 December 2013 approved the membership of the certification Commission of the Ministry, responsible for the certification of an authorized representative of a pharmaceuticals manufacturer for medical use. Elena Maximkina, Director of the Department for Medical Support and Regulation of the Circulation of Pharmaceuticals Products of the Ministry of Healthcare was appointed Chairman of the Commission, while the head of Roszdravnadzor Mikhail Murashko was appointed Deputy Chairman. The document also approved the members of the six expert groups of the certification commission.
The Ministry of Health of Russia prepared procedure for medical products compliance assessment for registration purposes
The Ministry of Healthcare has prepared the Procedure for Assessing the Compliance of Medical Products for the Purposes of State Registration. The compliance assessment is performed in the form of technical tests, clinical studies and toxicity studies.
The draft Procedure includes templates of acts which are to be issued based on the results of compliance assessments.
A manufacturer of medical products or its authorized representative should independently determine the expert organization to perform the technical tests and toxicity studies, with due account of its accreditation area, as well as the medical institution to perform the clinical studies.
Amendments proposed to Federal Law FZ-61 and the Tax Code
A draft of the Federal Law “On Amendments to the Federal Law On the Circulation of Pharmaceuticals and to Article 333.32.1. of Part Two of the Tax Code of the Russian Federation” was published on 27 January 2014.
It proposes adding the following part 9 to Article 55 of the Federal Law: “The list of pharmaceuticals provided under prescription shall be approved by the competent federal executive authority. The procedure governing the formation and revisions to the Rx list shall be established by the Government of Russia”.
The amendments to Article 333.32.1 of the Russian Tax Code introduce adjust the state duty payable for the actions taken by the competent federal executive authority during the state registration of pharmaceuticals. According to the draft, the amendments to the Tax Code should enter into force from January 2015.