In order to prevent falsification medicines in the state certification system there is a provision on a mandatory certificate for medical supplies. Control of manufactured pharmaceutical products is very important in conditions Russian market. The steady increase in prices for medicines provokes artisanal production of medicines and counterfeiting of medicines. To others negative indicator What makes drug certification necessary is the unacceptable rate of defects in pharmaceutical production. The pharmacy must provide the buyer with a sanitary and epidemiological certificate for any drug. Medicines are included in the nomenclature list of products subject to mandatory certification. Four types of drug certificates have been developed:
Certificate of production activity, which confirms that the quality control of pharmaceutical production is at the required level
Certificate for a pharmaceutical product intended for export
Medicines produced and imported into the territory of the Russian Federation must be certified in mandatory. Roszdravnadzor strictly monitors this. The Medicines Certification Center issues a certificate for pharmaceutical products only if the test results of an independent accredited laboratory meet the required standards and norms. The medicines certification system provides for certification actions based on an application submitted to the certification body. The procedure for certification of medicines involves submitting an application to the certification center, reviewing the application and documents, developing a certification scheme, and conducting laboratory tests of provided samples. Next, there is an analysis of technical documentation and research results, a decision to issue or refuse a certificate, registration of a certificate, inspection control of the quality of certified products put into circulation, corrective actions aimed at improving the quality of products to the required level state standards and normal. To quickly and efficiently obtain a mandatory quality certificate for medicines, contact our certification center, whose specialists have been involved in certification in the pharmaceutical field for a long time. By calling the specified phone number, you can receive comprehensive information regarding the certification of medicines and other medical products. We will be happy to provide you with any help and support to obtain a certificate with a 100% guarantee of a positive result.
In order to prevent counterfeiting of medicines, the state certification system has a provision on a mandatory certificate for medicines. Control of manufactured pharmaceutical products is very important in the Russian market. The steady increase in prices for medicines provokes artisanal production of medicines and counterfeiting of medicines. Another negative indicator that makes drug certification necessary is the unacceptable rate of defects in pharmaceutical production. The pharmacy must provide the buyer with a sanitary and epidemiological certificate for any drug. Medicines are included in the nomenclature list of products subject to mandatory certification. Certification medical products, as stated above, is prerequisite for releasing them into circulation on the territory of the Russian Federation. Four types of drug certificates have been developed:
Certification of conformity serves as confirmation that medicinal products meet GOST requirements regarding product quality
Certificate of production activity, which confirms that the quality control of pharmaceutical production is at the proper level
The registration certificate indicates that a certain medicinal product is permitted on the territory of the Russian Federation
Certificate for a pharmaceutical product intended for export.
Medicines produced and imported into the Russian Federation must be certified. Roszdravnadzor strictly monitors this. The Medicines Certification Center issues a certificate for pharmaceutical products only if the test results of an independent accredited laboratory meet the required standards and norms. The medicines certification system provides for certification actions based on an application submitted to the certification body. The procedure for certification of medicines and drugs involves submitting an application to the certification center, reviewing the application and documents, developing a certification scheme, and conducting laboratory tests of provided samples. Next, there is an analysis of technical documentation and research results, a decision to issue or refuse a certificate, registration of a certificate, inspection control of the quality of certified products put into circulation, corrective actions aimed at improving product quality to the required state standards and norms.
Product certification medical purposes takes place in local bodies of Roszdravnadzor. However, it must be emphasized that certification must be carried out not only pharmaceuticals, but also equipment. Certification medical equipment implies several types of registration in various government bodies. These steps must be completed to use the equipment in medical institution. This is not only a sanitary and epidemiological conclusion, but also registration in the register of the Ministry of Health. Certification of medical equipment is not the only condition for its use in hospitals and clinics. There is an institute for licensing medical technology and equipment. Exists special instructions, which regulates the procedure for hygienic assessment of medical devices. It is very important to provide all technical documentation, including technical specifications, for registration of medical equipment.
Certification of medical products is the most important condition for successful implementation in Russia. However, certification of equipment and medical products is associated with various difficulties. state registration. The collection of documentation and a certain procedure for certification actions are required, so it would be best to entrust this procedure to the experienced specialists of our certification center. To quickly and efficiently obtain a mandatory quality certificate for medicines, contact our certification center, whose specialists have been involved in certification in the pharmaceutical field for a long time. By calling the specified phone number, you can receive comprehensive information regarding the certification of medicines and other medical products. We will be happy to provide you with any help and support to obtain a certificate with a 100% guarantee of a positive result.
Registration and certification of products (medicines, medical devices, dietary supplements, cosmetical tools) in the relevant competent authorities of the Russian Federation and CIS countries.
The first step in the process of bringing a product to market Russian Federation 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 medicines, medical devices, dietary supplements and cosmetic products in Russia have a number of significant differences.
Registration of medicinal products.
Authorized federal body executive power The Ministry of Health and Social Development of Russia (www.minzdravsoc.ru) regulates the registration of medicines.
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:
- Federal Law No. 61-FZ “On the Circulation of Medicines” dated April 12, 2010 (came into force on September 1, 2010).
- 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.”
- 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:
- 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.
- Obtaining permission to conduct a clinical trial and conduct it in the Russian Federation.
- Quality examination medicinal product and examination of the relationship of expected benefit to possible risk use of a medicinal product 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 the medical use of the drug.
- Making a decision of the Ministry of Health and Social Development of Russia to include the drug in the State Register of Medicines and extract 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 Federal service for supervision in the field of healthcare and social development to provide public services for registration of medical products, as well as providing citizens and organizations with access to information about medical products that have been registered"
Normative base:
- Project Federal Law"About medical devices."
- 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.”
- 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.”
- Order of the Federal Service for Surveillance in the Sphere of Healthcare and Social Development dated November 9, 2007 N 3731-Pr/07 “On approval of the nomenclature classifier of medical devices and medical equipment (medical products).”
- 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.”
- 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.”
- 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 of 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:
- 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); individual species products that pose a potential danger to 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
- Federal Law of January 2, 2000 N 29-FZ “On the quality and safety of food products”.
- 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.”
- 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”
- 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.”
- 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 official document, which confirms the conformity of the certified product necessary requirements quality and safety established for this product by current standards: GOSTs or technical regulations.
Declaration – required form certification, through which the applicant, on the basis of available own evidence or evidence obtained with the direct participation of the certification body, certifies that the products released into free circulation by him 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.
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 significant difficulties for many participants in the medical device industry, 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 the quality of the medicinal product, pharmaceutical substance, biological material and other substances with which the medical device is manufactured 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). Most foreign-made medicines have 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:
Protecting the health of citizens is one of the key functions states, and monitoring the availability, quality and effectiveness of drugs, medical supplies and instruments is 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, restoring it 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 includes 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:
- medicines and drugs require state registration and certification in the GOST R system;
- 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:
- license to provide medical and pharmaceutical activities;
- 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 a comprehensive technical documentation, which includes 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 registration procedure for 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 even before starting the registration process.
Certification of medical products is intended to prevent the possibility of low-quality or dangerous medical products reaching the consumer. Certificates for medical products are issued only by authorized certification centers that are accredited in this field. One of such companies is our certification center Expert-Test. With our professional help, certification of the quality of medical products will be a simple procedure for you.
Features of conformity assessment
Medical drugs include drugs of artificial and natural origin, which can be produced in the form of mixtures, tablets, solutions, ointments, and so on. Certification of medical products is mandatory for drugs intended for anesthesia, radiocontrast drugs, psychotropic, narcotic and other substances.
To find out in detail about which specific permit you need to order and issue for your product, please contact the specialists of our expert center for advice. In our as soon as possible You can order a TR CU certificate, a declaration of conformity, as well as other permits at an affordable price in Moscow.
The price for certification of medical products will depend on several factors, but the main criterion that determines the cost of specialist services is the complexity of the procedure for assessing the conformity of products in Moscow or other regions of the country. The list of medical products subject to such a procedure as certification of the quality of medical products is regulated by Resolution of the State Standard of the Russian Federation No. 60, and is also indicated in the Letter of the State Committee for Standardization and Metrology dated January 15, 2003.
How permits are issued
Certificates for medical products are issued only after laboratory testing of the sample in a special research laboratory. Only those laboratories that are accredited by Rosstandart can conduct laboratory tests of medical products.
In order to start preparing a GOST R certificate of conformity or other necessary documents for products right now, you can contact us for professional help. With us you can register, buy and obtain all the necessary permits that are required for the legal sale of medical products in Russia.
The Expert-Test company provides a wide range of conformity assessment services in Moscow at reasonable prices various types products to the requirements of relevant standards and regulations. From us you can buy a CU TR declaration, a certificate or a letter of refusal for almost any type of product. We provide professional certification services not only in Moscow and the region, but throughout Russia.
