Documents with changes and explanations
Current rules for the registration of medical products
In order to arrange legal relations in the field of medical products circulation in the Russian Federation, the Government of the Russian Federation approved Resolution No. 1416 dated December 27, 2012 “On Approval of the Rules for State Registration of Medical Products”, according to which the Federal Service for Surveillance in Healthcare (hereinafter referred to as Roszdravnadzor) performs state registration of “any tools, apparatus, instruments, equipment, materials and other products used for medical purposes, alone or in combination with each other, and also together with other accessories necessary for the use of these products for the intended purpose”, which “are intended by the manufacturer (producer) for prevention, diagnosis, treatment and medical rehabilitation of diseases, monitoring the state of a human body, conducting medical research, restoring, replacing, changing the anatomical structure or physiological functions of a body, preventing or terminating pregnancy, the functional purpose of which is not realized by pharmacological, immunological, genetic or metabolic effects on a human body (hereinafter referred to as medical products)”. These rules give definitions of the basic concepts used for registration of medical products (hereinafter referred to as MP), clarify the procedure and algorithm of actions and procedures for registration of MP and relate to issuing, replacing and adjusting the main document to confirm the right to use MP on the territory of the Russian Federation, including operation and sale, that is a registration certificate (hereinafter referred to as RC) issued by Roszdravnadzor.
The rules for state registration of medical products were changed over the following years by amendments and additions to them:
- Resolution of the Government of the Russian Federation dated October 17, 2013 No. 930;
- Resolution of the Government of the Russian Federation dated July 17, 2014 No. 670;
- Resolution of the Government of the Russian Federation dated February 10, 2017 No. 160;
- Resolution of the Government of the Russian Federation dated May 31, 2018 No. 633.
The latest changes (dated May 31, 2018) touched upon the issues mainly affecting the following aspects:
- The interpretation of the concept of “authorized representative of a manufacturer (producer)” has been expanded, in which, besides a legal entity, an “individual entrepreneur” is clearly and unambiguously defined, which can represent the interests of the manufacturer (producer) regarding the circulation of a medical product in the Russian Federation, including procedures for assessing compliance and state registration of MP.
- It is indicated about the mandatory provision of information when submitting documents: on the permission to import a foreign MP for the purpose of its state registration, as well as copies of documents confirming the quality of a “pharmaceutical substance, biological material and other substance, which were used to manufacture a medical product or which are included as its compound and which are intended for use only in view of the purpose of a medical product, determined by the manufacturer, and issued in accordance with the laws of the country of origin of a medical agent, pharmaceutical substance, biological material and other substances”.
- In order to exclude inaccurate data, there is a rule that the text of the documents provided, as well as responses to requests from a foreign manufacturer (producer) and/or developer of MP, compiled in a foreign language, must be translated into Russian and certified through the prescribed manner (notarized).
- A subparagraph has been added, which expands the grounds for the registration authority to make a decision to refuse the state registration in case of “inconsistencies in the data on the effectiveness and safety of a medical product with the data on a medical product contained in the registration application” and the documents provided, even despite the conclusion of the expert institutions on the positive results of MD quality, efficiency and safety examination.
- A rule has been set, according to which a notification is considered to be received in case the term for its sending by registered mail is more than 10 business days.
- An emphasis on the need to indicate a trademark and other means of individualization of MP on the labeling and documentation was added.
- An emphasis on introducing documents stored in the registration dossier – when making changes to RC, as well as during inspections of MP being operated, was made.
- The sub-clause on specifying the type of medical product in RC in accordance with the nomenclature classification of medical products approved by the Ministry of Health of the Russian Federation has been deleted.
- The following was clarified: a list of changes made to the documents of the registration dossier that do not require quality, efficiency and safety examination of MP, which is already in circulation, as well as the procedure and list of the documents necessary for making changes.
- The deadline for making changes to the documents contained in the registration dossier of MP, requiring quality, effectiveness and safety examination of a medical product, should be not more than 35 working days from the date of the decision to consider the application for changes and documents.
- A clause has been introduced according to which the grounds for concluding that it is impossible to make changes to documents on MP, which are in the registration dossier, and therefore – a refusal of registration actions, up to and including revocation of the current RC, can also occur when the registration authority based on the results of the state control over the circulation of medical products detects unreliability of the information submitted, substantiating the introduction of changes and/or absence in the documents submitted by the applicant of the information confirming that changes being made to the documents contained in the registration dossier, do not involve changes in the properties and characteristics that affect the quality, efficacy and safety of a medical product, or improve the properties and characteristics with unchanged functionality and/or mode of function of a medical product.
- The issues of interaction between the registration authority (Roszdravnadzor) and an expert institution performing MP quality, effectiveness and safety examination were adjusted.
- It has been added that an opinion of an expert institution on the results of expert examinations conducted by it in accordance with these Rules may be appealed.
Product classification according to OKPD2 code
Not so long ago, the All-Russian Classifier of Products – OKP (OK 005-93), which was part of the Unified System of Classification and Codification of Technical and Economic and Social Information (YeSKK) of the Russian Federation, was used throughout the territory of the Russian Federation.
The Order of the Federal Agency on Technical Regulation and Metrology (Rostekhregulirovaniye) dated November 22, 2007 No. 329-st adopted the All-Russian Classifier of Products by Type of Economic Activity OKPD (OK 034-2007 [CPA 2002]) with the effective date from January 1, 2008 for the period up to January 1, 2013, without canceling the All-Russian Product Classifier OKP (OK 005-93). The validity of OKP classifier has been repeatedly extended in the future. For example, by the Order of Rosstandart dated November 10, 2015 No. 1745-st, the expiry date of OK 005-93 was postponed to January, 1 2017 (IUS No. 1, 2016).
Currently, the All-Russian Classifier of Products by Type of Economic Activity – OKPD 2 (OK 034-2014) is widely used, which was enacted by the Order of the Federal Agency on Technical Regulation and Metrology dated January 31, 2014 No. 14-St “On the adoption and enactment of the All-Russian Classifier of Types of Economic Activity (OKVED2) OK 029-2014 [NACE Rev. 2] and the All-Russian Classifier of Products by Type of Economic Activity (OKPD2) OK 034-2014 [CPA 2008] ”(with amendments as of October 16, 2018), with the following cancellation of the All-Russian Classifier of Economic Activities OKVED (OK 029-2001) [NACE Rev. 1], the All-Russian Classifier of Economic Activities OKVED (OK 029-2007) [NACE Rev. 1.1], the All-Russian Classifier of Economic Activities, Products and Services OKDP (OK 004-93), the All-Russian Classifier of Products by Type of Economic Activity OKPD (OK 034-2007) [CPA 2002], the All-Union Classifier of Services Rendered to the Public OKUN (OK 002-93) and the All-Russian Classifier of Products OKP (OK 005-93). This was done in order to implement the “Action Plan for the formation of a methodology for information systematization and coding, as well as improvement and updating of all-Russian classifiers, registers and information resources”.
The All-Russian Classifier of Products by Type of Economic Activity – OKPD 2 – is part of the national standardization system of the Russian Federation. Products (services, works) are objects of classification in OKPD 2. OKPD 2 is designed to provide information support for tasks related to:
- classification and coding of products (services, works) for the purposes of state statistics;
- development of regulatory legal acts relating to state regulation of certain types of economic activity;
- implementation of a set of accounting functions within the framework of state statistics work related to meeting the needs of state authorities and management in the information about products by type of economic activity when solving analytical problems;
- ensuring the system of state contracting and wholesale trade in the domestic market;
- preparation of statistical information for comparisons at the international level;
- placing orders for goods, works (services) for state and municipal needs;
- ensuring classification of fixed assets used in the All-Russian Classifier of Fixed Assets;
- standardization and mandatory conformity of products compliance;
- classification and coding of services provided to the population by business entities.
OKPD 2 is built based on harmonization with the Statistical Classification of Products by Activity in the European Economic Community [CPA 2008], by keeping unchanged codes (up to six characters inclusive) and the concepts of the corresponding positions of CPA 2008 in OKPD 2. At the same time, there are cases for which national characteristics are reflected by changing CPA 2008 groupings with 2-6-bit codes.
In OKPD 2, a hierarchical classification method and a sequential coding method are used. The code consists of 2-9 numeric characters. Features reflecting the needs of the Russian economy in products detailing are taken into account in OKPD 2 groups with 7-9-bit codes.
In order to ensure compliance of the code designations of OKPD 2 and CPA 2008, a dot is put between the second and the third, the fourth and the fifth characters of the code. In case there are 2 additional division levels in comparison with CPA 2008, the dot is also placed between the sixth and the seventh characters of the code. By analogy with CPA 2008, OKPD 2 includes sections and subsections with preserving their letter designations.
In cases when the type is not divided into categories, i.e. there is no detailing of products (services, works) at the national level, 7–9 code characters have the value “0” (zero), and in cases where division is made, 7–8 code characters have a value other than “0” ( zero).
Detailing at the bottom level of the classification division is performed only in cases when the product (services, work) category is divided into several subcategories.
Considering that CPA 2008 is harmonized with the Statistical Classification of Economic Activities in the European Economic Community (NACE Rev. 2), the All-Russian Classification of Economic Activities OKVED 2 is built based on harmonization with NACE Rev. 2, and OKPD 2 is based on harmonization with CPA 2008, as a rule, a correspondence is established for the first four characters of codes between the type of activity in OKVED 2 and the result of this type of activity in the form of products (services, works) in OKPD 2.
The Ministry of Economic Development of Russia provides for the development and submission for the adoption of changes in OKPD 2 in the manner established by the Rules for Standardization PR 50.1.024-2005 “Basic provisions and procedures for the development, maintenance and implementation of all-Russian classifiers”.
Thus, OKPD 2 classifier is widely used when implementing registration procedures and further handling of medical products (MP), as well as making changes to the documentation of the registration dossier of MP registered through the prescribed manner and replacing the registration certificate issued earlier by Roszdravnadzor.
It is important to note that medical products in OKPD 2 Classifier are presented not only in the Section C: grouping (class 26) 26.6 “Equipment for radiation, electrical diagnostic and therapeutic, used for medical purposes” and grouping (class 32) 32.5 “Medical instruments and equipment”, but also in such subclasses as:
– 188.8.131.52 – “Medical refrigerators, freezers”;
– 184.108.40.206 – “Medical centrifuges”;
– 220.127.116.11 – “Medical hand frames, carts”;
– 18.104.22.168 – “Other legwear garment used for medical purposes”;
– 22.214.171.124 – “Medical bandages”;
– 126.96.36.199 – “Medical gauze”;
It should also be noted that for foreign MP imported into our country from abroad, the following documents are important:
- Resolution of the Government of the Russian Federation No. 688 dated September 15, 2008 “On approval of a lists of codes of medical goods subject to value added tax at a tax rate of 10 percent”, with amendments as of March 20, 2018
- Resolution of the Government of the Russian Federation No. 1042 dated September 15, 2008 “On approval of a list of medical goods, the sale of which in the Russian Federation and the import of which into the territory of the Russian Federation and other territories under its jurisdiction, are not subject to value added tax (exempted from taxation)”, with amendments as of March 20, 2018
1) OKPD 2 codes, listed in a list of the Resolution No. 688 dated September 15, 2008, are applied to – including medical products, except medical products, the sale of which is exempted from taxation in accordance with sub-cl. 1 of cl. 2 of Art. 149 of the Tax Code of the Russian Federation, when submitting to the tax authority a registration certificate of a medical product issued in accordance with the law of the Eurasian Economic Union (EAU), or until December 31, 2021 – when submitting a registration certificate for a medical product (a registration certificate for a medical product (medical equipment)) issued in accordance with the legislation of the Russian Federation.
2) For the purposes of applying Section I of a list of the Resolution No. 1042, it is necessary to be guided by EEU TN VED indicated codes with reference to the corresponding code on OKP (OK 005-93) product classifier or OKPD 2 (OK 034-2014) provided that medical products are registered in accordance with the right of the Eurasian Economic Union or until December 31, 2021 of the state registration of medical products in accordance with the legislation of the Russian Federation.
3) For the purpose of applying Sections II-IV of a list of the Resolution No. 1042, it is necessary to be guided by EEU TN VED code, product name with reference to the corresponding code on OKP (OK 005-93) product classifier or OKPD 2 (OK 034-2014), in case such codes are indicated.