Certification of medicines on the territory of the Russian Federation is considered a mandatory procedure. Certification of medicines Certificate of conformity of drugs

Dear readers!

We are often contacted with the question of what additional documents need to be submitted to Roszdravnadzor to fulfill the requirements of subparagraph “n” of paragraph 10 of the Rules for state registration of medical devices (Resolution of the Government of the Russian Federation No. 1416).

Background

Until June 2018 medical products containing drugs (pharmaceutical substances or drugs) could not, in principle, be registered if the drug was not registered in Russia. This created severe difficulties for many participants in the field of medical devices, especially in the fields of cosmetology and dentistry.

In March 2018 MEDRELIS LLC was prepared. The initiative was supported by many participants in the sphere of circulation of medical devices, and as a result it was held.

As a result, May 31, 2018 Resolution of the Government of the Russian Federation No. 633 was adopted, amending the Rules for state registration of medical devices. Thus, among other things, the list of documents provided to Roszdravnadzor during registration was supplemented with subparagraph “n” with the following content:

"m) copies of documents confirming quality medicinal product, pharmaceutical substance, biological material and other substances used to manufacture a medical device or which are included in its composition and which are intended for use only taking into account the purpose of the medical product determined by the manufacturer, and issued in accordance with the legislation of the country of origin of the medicinal product, pharmaceutical substance , biological material and other substances"

Thus, it has become possible to use medicines not registered in the Russian Federation in medical products, subject to the provision of appropriate supporting documents. Recently, Roszdravnadzor specified these documents, but this specification still did not provide sufficient clarity. We would like to take the liberty of commenting on Roszdravnadzor’s response, showing examples from our successful experience in registering such medical devices.

What documents are needed?

So, Roszdravnadzor indicates that such documents may include:

Manufacturer's document confirming the quality of a medicinal product of an industrial series or batch (analysis protocol or certificate of analysis)

A Certificate of Analysis (COA) is a document that a manufacturer draws up based on the results of final control of a specific batch of a drug (or other substance). Majority medicines foreign production has such a document. In different countries it is regulated by different documents, but the basic information that such a document contains remains unchanged. We would like to analyze the content of the certificate of analysis using the example of the legislation of the European Union, where it is regulated by section 11.4 of the EU GMP Guide Part II. According to the requirements of this document, the certificate of analysis contains:

• Name of the intermediate or API (name of substance)
• Batch number
• Release date
• Expiry date
• List of the tests performed including acceptance limits (list of tests performed, including acceptance criteria)
• Numerical results
• Dated signature by authorized personnel (date and signature of the authorized person)

Note from MEDRELIS LLC: In fact, many manufacturers use an electronic signature, in which case a paper signature on the certificate of analysis is not required.

• Name of the manufacturer

Note from MEDRELIS LLC: the manufacturer of the substance/drug, not the medical device in which it is used.

• and Name of the laboratory (and name of the laboratory)

Note from MEDRELIS LLC: indicated only if the analysis was carried out not by the manufacturer itself, but by a third-party laboratory.

An example of a certificate of analysis can be viewed below:

Source: http://www.humate.info/fertilizer-edta-zn-15.html

Quality documentation describing control methods

As such documentation we see a safety data sheet (Material Safety Data Sheet, MSDS, SDS). It is compiled, as a rule, for products that, from the point of view of foreign legislation, can be classified as “other substances” (for example, sodium chloride, brilliant blue, silicon oxide). It is important to note that the safety data sheet is not issued for a specific batch of a substance, but for the substance as a whole.

Consider, again, the example of the European Union. The contents of the safety data sheet are regulated by the following documents:

A copy of the license for the production of a medicinal product issued by the authorized body of the manufacturing country

May be different in different countries. Issued by competent government agency(for example, Food and Drug Administration (FDA) in the USA, Food and Drugs Control Administration (FDCA) in India, etc.

An example of a license for the production of a medicinal product can be seen below:

Medicines are subject to mandatory certification. List of products for which legislative acts Russian Federation mandatory certification is provided for, established by Resolution of the State Standard of the Russian Federation dated July 30, 2002 No. 64 “Nomenclature of products in respect of which the legislative acts of the Russian Federation provide for mandatory certification.” This List includes medicines, chemical-pharmaceutical products and products medical purposes.

Resolution of the State Standard of the Russian Federation dated May 24, 2002 No. 36 approved the Rules for certification in the certification system of medicines of the GOST R certification system (hereinafter referred to as Rules No. 36).

According to Rules No. 36:

“The following medicinal products are subject to mandatory certification:

- produced by drug manufacturing enterprises on the territory of the Russian Federation;

- imported into the territory of the Russian Federation in the manner established by current legislation.”

Groups of medicines not subject to mandatory certification are given in the Letter State Committee Russian Federation on Standardization and Metrology dated January 15, 2003 No. IK-110-25/110 “On medicinal products not subject to certification”:

“For information purposes, I inform you that in accordance with the scope of the “Rules for Certification in the Certification System of Medicines of the GOST R Certification System”, approved by the Resolution of the State Standard of Russia dated May 24, 2002 No. 36, and the Law of the Russian Federation “On the Protection of Consumer Rights” is not The following groups of medicines are subject to mandatory certification:

- medicines without individual packaging (in bulk), not intended for retail sale;

- pharmaceutical substances for the production of medicines;

- immunobiological preparations, vaccines, serums (not included in the list of goods for which confirmation of mandatory certification is required).”

The certificate of conformity of a medicinal product is issued by the medicinal product certification authorities after checking the medicinal product for compliance with the requirements. regulatory documents, approved by the federal executive body in the field of healthcare, for the applicant.

Medicine quality certificate- a document confirming the compliance of the quality of the medicinal product with the state standard for the quality of medicinal products (Article 4 of Law No. 86-FZ);

The validity period of the certificate for a batch (series) of medicines is not established. The certificate is valid for delivery or sale of a batch of products during the shelf life of the medicinal product established by regulatory documents.

A production organization that has received a certificate of conformity for manufactured products initially reflects the costs associated with its receipt on account 97 “Deferred expenses”. In accordance with Article 170 of the Tax Code of the Russian Federation, VAT amounts charged to the taxpayer when purchasing goods (work, services) are not included in the expenses accepted for deduction when calculating the income tax (profit tax) of the organization.

This means that the debit of account 97 “Deferred expenses” must take into account the amount of certification costs minus VAT (if there is a corresponding invoice). VAT on the purchased service is recorded as a debit to account 19 “Value added tax on purchased assets.”

Future expenses are written off for production and distribution costs in equal parts during the validity period of the certificate. Consequently, VAT amounts should be deducted in the same way. This point of view is expressed by the tax authorities. This can be confirmed by the Letter of the Department of Taxation of the Russian Federation for the city of Moscow dated August 10, 2004 No. 24-11/52247 “On the legality of VAT deduction.”

The text of Chapter 21 “Value Added Tax” of the Tax Code of the Russian Federation does not contain a direct indication that VAT on expenses of future periods should be deducted only at the time of writing off such expenses on products, that is, in stages. Tax legislation on VAT from January 1, 2006 imposes three requirements that a VAT taxpayer applying for a deduction must fulfill:

purchased goods (works, services), property rights must be used by the taxpayer to carry out taxable transactions;

goods (work, services), property rights must be accepted by the taxpayer for accounting;

The taxpayer must have a properly executed invoice in his hands.

If a manufacturing organization receives a certificate of conformity for manufactured products, we have:

the certificate is required by the organization to carry out taxable activities;

the certification body provided the certification service (based on the signing of the service performance certificate);

the organization accepted the service for accounting, - the accountant reflected the cost of the service on the balance sheet as part of deferred expenses;

The organization has an invoice in its hands.

That is, an organization that is a VAT payer has met all the requirements of tax legislation, so it is possible to deduct all “input” VAT at once.

Using the second point of view may lead to litigation, but we have provided arguments that will help the taxpayer defend his case. If you are not ready to enter into an argument with tax authority, use the first point of view.

Pay attention!

Until January 1, 2006 for VAT deduction a necessary condition There was also payment for goods (work, services). From this date, the requirement to pay for purchased goods (work, services), presented to the taxpayer claiming a deduction, was actually removed by the legislator. Such changes were made to Article 171 of the Tax Code of the Russian Federation by Federal Law of July 22, 2005 No. 119-FZ “On Amendments to Chapter 21 of Part Two Tax Code of the Russian Federation and on the recognition as invalid of certain provisions of acts of legislation of the Russian Federation on taxes and fees” (hereinafter referred to as Law No. 119-FZ). Thus, from January 1, 2006, a VAT taxpayer claiming a deduction must meet only three conditions: the amount of tax must be presented to him for payment, he has an invoice in hand, filled out properly, and the purchased goods (work, services) , property rights must be taken into account.

You can find out more about the issues of certification of medicines in the book of JSC “BKR-Intercom-Audit” “Production and trade in medicine and cosmetics”.

Legal regulation of quality control of medicines

State control for the quality of medicines includes measures aimed at compliance with the requirements of acts of legislation of the Russian Federation regulating the provision of medicines, and all medicines imported and manufactured in the Russian Federation and imported into the territory of the Russian Federation are subject to it.

Medicines are special products that can cause harm to human health if the rules of development, testing, production, storage, sale, and use are violated. Therefore, it is necessary to introduce a strictly regulated system for monitoring all stages of drug promotion from their creation to human consumption. State control over the quality of drugs in the Russian Federation is regulated by the following main regulatory documents:

Law of the Russian Federation of February 7, 1992 N 2300-1 “On the Protection of Consumer Rights” (as amended and supplemented by June 2, 1993, January 9, 1996, December 17, 1999, December 30, 2001 , August 22, 2004);

Resolution of the State Standard of Russia dated May 24, 2002 No. 36 On the approval and implementation of the “Rules for certification in the Certification System of Medicines of the GOST Certification System of the Russian Federation”;

Decree of the Government of the Russian Federation of July 7, 1999 No. 766 “On approval of the list of products subject to declaration of conformity, the procedure for accepting a declaration of conformity and its registration”;

Decree of the Government of the Russian Federation of December 1, 2009 No. 982 “On approval of a unified list of products subject to mandatory certification and a unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity”;

Decree of the Government of the Russian Federation of July 6, 2006 No. 416 “On approval of the Licensing Regulations pharmaceutical activities";

Decree of the Government of the Russian Federation of September 3, 2010 No. 684 “On approval of the Regulations on licensing the production of medicines”;

Order of the Ministry of Health of the Russian Federation dated October 30, 2006 No. 734 “On approval of the Administrative Regulations Federal service on supervision in the field of healthcare for the performance of the state function of organizing the examination of the quality, effectiveness and safety of medicines";

Order of the Ministry of Health of the Russian Federation dated March 4, 2003 N 80 “On approval of the Industry Standard “Rules for the dispensing (sale) of medicines in pharmacies. Basic provisions";

Order of the Ministry of Health of the Russian Federation dated December 28, 2010 No. 1222n “On approval of the Rules wholesale trade medicines for medical use";

Order of the Ministry of Health of the Russian Federation of August 23, 2010 N 706n “On approval of rules for storing medicines”;

Order of the Ministry of Health of Russia dated July 16, 1997 No. 214 “On quality control of medicines manufactured in pharmacies”;

Order of the Ministry of Health of Russia dated October 21, 1997 No. 309 “On approval of instructions on the sanitary regime pharmacy organizations(pharmacy)";

Order of the Ministry of Health of Russia dated October 21, 1997 No. 308 “On approval of instructions for the production of liquid dosage forms in pharmacies”;

Order of the Ministry of Health of Russia dated October 16, 1997 No. 305 “On the norms of deviations permissible in the manufacture of medicines and packaging of industrial products in pharmacies.”

Registration and certification of products (medicines, medical devices, dietary supplements, cosmetics) in the relevant competent authorities of the Russian Federation and CIS countries.

The first step in the process of introducing a product to the Russian Federation market is its registration. Registration is a state examination of the quality, effectiveness and safety of a drug with the aim of subsequently authorizing the medical use of the drug in the Russian Federation.

Registration procedures for medicinal products, medical devices, biological active additives and cosmetic products in Russia have a number of significant differences.

Registration of medicinal products.

The authorized federal executive body regulating the registration of medicines is the Ministry of Health and Social Development of Russia (www.minzdravsoc.ru).

A separate Department has been formed in the Ministry of Health and Social Development of Russia government regulation Circulation of Medicines, whose department deals with issues of registration of new and circulation of already registered medicines.

In 2010, the procedure for registering medicines was significantly changed due to the adoption of the new Federal Law No. 61-FZ “On the Circulation of Medicines” dated April 12, 2010, which came into force on September 1, 2010. To date, 4 changes to the law have been adopted: No. 192-FZ of July 27, 2010, No. 271-FZ of October 11, 2010, No. 313-FZ of November 29, 2010, No. 409-FZ of December 6, 2011.

Regulatory legal acts regulating the registration procedure for medicines:

1. Federal Law No. 61-FZ “On the Circulation of Medicines” dated April 12, 2010 (came into force on September 1, 2010).
2. Order of the Ministry of Health and Social Development of the Russian Federation dated November 23, 2011 N 1413n “On approval Methodological recommendations by content and design necessary documents, from which a registration dossier for a medicinal product for medical use is formed for the purpose of its state registration.”
3. Order No. 750n dated August 26, 2010 “On approval of the rules for conducting the examination of medicines for medical use and the form of the expert commission’s conclusion.”

Registration procedure for foreign and Russian drugs the same.

The registration procedure consists of 4 consecutive stages:

1. Drawing up a registration dossier, including documents necessary to get started clinical trial, and submission of the dossier to the Ministry of Health and Social Development of Russia.
2. Obtaining permission to conduct a clinical trial and conduct it in the Russian Federation.
3. Examination of the quality of a medicinal product and examination of the relationship between expected benefit and possible risk use of the drug, carried out after its clinical trial: The third stage can be divided into 2 substages:

   3a). Quality control of the drug in the laboratory of the Federal State Budgetary Institution NTsESMP and approval of the Regulatory Document;

   3b). Examination of the relationship between the expected benefit and the possible risk of use and approval of the Instructions for medical use drug.

4. The decision of the Ministry of Health and Social Development of Russia to include the drug in State Register medications and discharge registration certificate.

Registration deadlines

In accordance with Law No. 61-FZ “On the Circulation of Medicines”, the registration period is 210 working days. This period does not include the time required to conduct a clinical trial.

Registration of medical devices

The authorized federal executive body regulating the registration of medical products is Roszdravnadzor (www.roszdravnadzor.ru).

The procedure for registration of medical devices is regulated by the “Administrative Regulations of the Federal Service for Surveillance in Healthcare and social development by providing public services on registration of medical products, as well as providing citizens and organizations with access to information about medical products that have been registered"

Regulatory framework:

1. Project Federal Law"About medical devices."
2. Order of the Ministry of Health and Social Development of the Russian Federation dated October 30, 2006 N 735 “On approval of the Administrative Regulations of the Federal Service for Surveillance in the Sphere of Health and Social Development for the performance of the state function of registering medical products.”
3. Decree of the Government of the Russian Federation of September 15, 2008 N 688 “On approval of lists of codes of medical goods subject to value added tax at a tax rate of 10 percent.”
4. Order of the Federal Service for Supervision in the Sphere of Healthcare and Social Development dated November 9, 2007 N 3731-Pr/07 “On approval nomenclature classifier medical products and medical equipment (medical products).”
5. Decree of the Government of the Russian Federation of August 13, 1997 N 1013 “On approval of the list of goods subject to mandatory certification and the list of works and services subject to mandatory certification.”
6. Letter of the Federal Customs Service of Russia dated March 27, 2008 N 01-11/11534 “On sending the List of goods for which sanitary and epidemiological certificates or certificates of state registration must be issued during customs clearance.”
7. State registration of medical devices is carried out by Roszdravnadzor on the basis positive results relevant tests (research) (technical, toxicological, clinical), as well as positive conclusions Expert commissions on examination of the quality, effectiveness and safety of medical products.

The period for providing the state service for state registration of a medical device should not exceed 140 days from the date of registration with Roszdravnadzor of the set of documents provided for in paragraphs. 26-29 of the Administrative Regulations.

Detailed information on state registration of imported medical devices on the Roszdravnadzor website:

State registration food additives and cosmetics

The authorized federal executive body regulating the registration of dietary supplements and cosmetics is Rospotrebnadzor (www.rospotrebnadzor.ru)

Registration of dietary supplements, cosmetics, food additives, raw materials for dietary supplements is carried out in accordance with:

1. Order of the Ministry of Health and Social Development of the Russian Federation dated October 19, 2007 N 657 “On approval of the Administrative Regulations of the Federal Service for Surveillance in the Field of Protection of Consumer Rights and Human Welfare for the performance of the state function of state registration of chemicals introduced into production for the first time and previously not used, biological substances and drugs manufactured on their basis that are potentially dangerous to humans (except for medicines); certain types of products representing potential danger for humans (except for medicines); certain types of products, including food products, imported into the territory of the Russian Federation for the first time,” as well as
2. Federal Law of January 2, 2000 N 29-FZ “On the quality and safety of food products”.
3. Order of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare of July 19, 2007 N 224 “On sanitary and epidemiological examinations, examinations, research, testing and toxicological, hygienic and other types of assessments.”
4. Letter of the Federal Customs Service of Russia dated March 27, 2008 N 01-11/11534 “On sending the List of goods for which sanitary and epidemiological certificates or certificates of state registration during customs clearance must be issued”
5. Decree of the Government of the Russian Federation of September 15, 2008 N 688 “On approval of lists of codes of medical goods subject to value added tax at a tax rate of 10 percent.”
6. Order of the Federal Service for Surveillance in the Sphere of Consumer Rights Protection and Human Welfare of July 19, 2007 N 224 “On sanitary and epidemiological examinations, examinations, research, testing and toxicological, hygienic and other types of assessments.”

Documents provided by the applicant for state registrationhttp://rospotrebnadzor.ru/directions_of_activity/gosreg/33350

After receiving the Certificate of State Registration, it is necessary to undergo procedures to confirm the quality of the product in the form of certification or declaration.

Certification and declaration

Each product sold in Russia must meet the requirements of certain state standards. That is why a certificate or declaration must be issued for goods that, one way or another, can affect the life and health of people.

Certificate of Conformity is an official document that confirms the conformity of the certified product necessary requirements quality and safety established for this product by current standards: GOSTs or technical regulations.

Declaration– a mandatory form of certification, through which the applicant, on the basis of his own evidence or evidence obtained with the direct participation of the certification body, certifies that the products he releases for free circulation comply with the requirements of the provisions of state standards.

The procedure for accepting a declaration of conformity is carried out directly by the manufacturer or supplier of certain goods on the basis of available documentary evidence confirmed as a result of an independent examination.

Products, passed the procedure declaration, has official proof high level quality, and ultimately inspires consumer confidence.

All company services are provided in strict accordance with legal requirements, as well as the company's codes of ethical business conduct and marketing practices.

Protecting the health of citizens is one of the key functions of the state, and control over the availability, quality and effectiveness of medicines, medical supplies and tools are an important part of this work. The certification procedure is designed to ensure the safety and quality of medical products and prevent their falsification on the market.

What is meant by medications?

Firstly, these are all materials and products used for medical purposes, namely for prevention and treatment, diagnosis of human diseases, and research human body and monitoring its condition, restoration of its anatomical structure and functions. And if, for example, according to EU legislation, only something that has direct contact with the patient’s body is considered a medical device, then Russian legislation classifies hospital furniture and even specialized equipment as medical products. software. Manufacturers need to take this feature into account.

Secondly, these are medicines, pharmacological preparations.

Features of certification of medical products

Absolutely all medical products are subject to state registration, which is carried out by Roszdravnadzor and the Ministry of Health, but for different types Registration procedures for medical products are different.

The following main groups of permitting documents in the field of medicine are distinguished:

• for finished products:
  1. medicines and drugs require state registration and certification in the GOST R system;
  2. medical products, instruments, materials are also subject to state registration with subsequent execution of a declaration of conformity to GOST R;

• on production processes and service provision:
  1. licenses to carry out medical and pharmaceutical activities;
  2. certification of the production of medical products and medicines: GMP and GOST ISO 13485 certificates.

Stages and duration of state registration of medicines

The procedure for registering medical devices is established by Decree of the Government of the Russian Federation N 1416 dated December 27, 2012 and includes the following mandatory steps:

• research and testing: clinical, technical, toxicological, and, if applicable, for type approval of measuring instruments;
• filing an application for registration with comprehensive technical documentation, including regulatory, technical documents for the product, instructions or user manual, photographic materials, documented test results;
• examination of safety, effectiveness, quality;
• registration certificate, which will be valid indefinitely.

Important note: The above procedure applies to medical devices. The procedure for registering drugs is currently undergoing significant changes - it is reaching the supranational level. The procedure will be the same for all countries of the Customs Union!

In May 2017, a large package of EAEU regulatory documents was adopted, which will allow drug manufacturers to register their products in any one country of the Union according to unified standards and freely sell them in other countries too. This is definitely a big step forward! It is expected that this will have a direct impact on reducing drug prices. Currently, Roszdravnadzor and relevant departments of other states are discussing the translation process national systems registration of pharmaceutical substances for new mechanisms.

Currently, the procedure for registering medical products takes from 8 to 18 months and is extremely dependent on both the quality of the product itself and the professionalism of the preparation of the package of documents. This should be done by high-level experts who thoroughly understand the intricacies of the procedure.

If you are faced with the task of obtaining a Roszdravnadzor registration certificate for your product, we recommend that you seek advice from the specialists of our certification center before starting the registration process.