Declaration and certification of medicines. Certification of medicines

Dear readers!

We are often asked what documents additionally need to be submitted to Roszdravnadzor in order to fulfill the requirements of subparagraph “n” of paragraph 10 of the Rules for State Registration medical devices(Decree of the Government of the Russian Federation No. 1416).

Background

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

March 2018 LLC "MEDRELIS" was prepared. The initiative was supported by many participants in the sphere of circulation of medical devices, and according to its results, it took place.

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

"m) copies of documents confirming the quality medicinal product, pharmaceutical substance, biological material and other substance, with the use of which a 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 device, 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 substance"

Thus, it has become possible to use medicines not registered in the Russian Federation as part of medical devices, subject to the provision of relevant supporting documents. Roszdravnadzor recently specified these documents, but this specification still did not bring sufficient clarity. We would like to take the liberty of commenting on the response of Roszdravnadzor, 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 batch or batch (analysis protocol or analysis certificate)

A Certificate of Analysis (COA) is a document that a manufacturer draws up based on the results of the final control of a specific batch of a medicinal product (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 on 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 (substance name)
Batch number (batch number)
Release date (release date)
Expiry date
List of the tests performed including acceptance limits
Numerical results (quantitative results)
Dated signature by authorized personnel (date and signature of the authorized person)

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

Name of the manufacturer (manufacturer name)

Note of LLC "MEDRELIS": the manufacturer of the substance / medicinal product, and not the medical device in which it is used.

and Name of the laboratory

Note of MEDRELIS LLC: indicated only if the analysis was carried out not by the manufacturer, 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, in terms 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 issued not for a specific batch of a substance, but for the substance as a whole.

Consider, again, the example of the European Union. In it, the content of the safety data sheet is regulated by the following documents:

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

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

An example of a license to manufacture a medicinal product can be viewed below:

The system for confirming the compliance of medicines, medical devices with regulatory quality requirements Lecture for 4th year students of the FVSOFGBOU VO Tyumen State Medical University of the Ministry of Health of the Russian Federation Department of Pharmacy Management and Economics Medical and Pharmaceutical Commodity Science

2 Lecture plan 1. Regulatory and legal framework of the conformity assessment system in healthcare and pharmacy of the Russian Federation. 2. System of confirmation of conformity in the Russian Federation. Legislative bases. Basic concepts. 3. Types and forms of confirmation of compliance (voluntary, mandatory). 4. RF certification system. Certification management bodies. The structure of certification bodies. Main goals and objectives, powers. 5. Declaration of conformity of drugs. Basic provisions. Documents confirming the compliance of drugs.

3 3 Regulatory framework for the conformity assessment (certification) system in health care and pharmacy: Federal Law of 27.12.2002 No. 184-FZ “On Technical Regulation”; Law of the Russian Federation "On Protection of Consumer Rights" (dated February 7, 1992, as amended); Federal Law of November 21, 2011 No. 323-FZ “On the fundamentals of protecting the health of citizens in Russian Federation"(in the current edition); Federal Law of April 12, 2010 No. 61-FZ "On the circulation of medicines"; Decree of the Government of the Russian Federation of 01. 12. 2009 No. 982 “On the Unified List of Products, Conformity Confirmation of which is carried out in the form of mandatory certification and the Unified List of Products, conformity confirmation of which is carried out in the form of a Declaration of Conformity”; Order of the Ministry of Industry and Energy of the Russian Federation of December 26, 2006 No. 425 “On approval of guidelines for the adoption and registration of a declaration of conformity of medicines” and other regulatory legal acts.

4 4 Legislative framework The basic concepts, goals, principles, types and forms of activity in the field of conformity assessment, as well as the functions of certification bodies are established by the Federal Law of 27. 12. 2002 No. 184-FZ "On Technical Regulation"

5 Confirmation of conformity - documentary evidence of compliance of products or other objects, design processes (including surveys), production, construction, installation, adjustment, operation, storage, transportation, sale and disposal, performance of work or provision of services with the requirements of technical regulations, provisions of standards, codes rules or terms of contracts.

6 6 Conformity assessment is carried out in order to: certify the conformity of products, production processes, operation, storage, transportation, sale and disposal, works, services or other objects with technical regulations, standards, terms of contracts; assistance to purchasers in the competent choice of products, works, services; increasing the competitiveness of products, works, services in the Russian and international markets; creating conditions for ensuring the free movement of goods across the territory of the Russian Federation, as well as for the implementation of international economic, scientific and technical cooperation and international trade.

7 The conformity assessment form is a certain procedure for documenting the conformity of products or other objects, design processes (including surveys), production, construction, installation, commissioning, operation, storage, transportation, sale and disposal, performance of work or provision of services to the requirements of technical regulations , the provisions of standards or the terms of contracts.

8 8 Types and forms of confirmation of conformity (Article 20 of the Federal Law "On technical regulation") Type 1 - Voluntary confirmation of conformity in the form of Voluntary certification. Type 2 - Mandatory confirmation of conformity in two forms: Mandatory certification Declaration of conformity

9 Voluntary confirmation of conformity — Voluntary confirmation of conformity is carried out at the initiative of the applicant on the terms of the agreement between the applicant and the certification body. Voluntary confirmation of conformity can be carried out to establish compliance with national standards, standards of organizations, voluntary certification systems, and the terms of contracts.

10 10 Mandatory confirmation of conformity - - a set of actions officially accepted as evidence of the compliance of medicines with the requirements of the technical regulation and standard.

11 11 Declaration of conformity of medicines — Since January 1, 2007, the mandatory certification of medicines has been replaced by a declaration of conformity. Declaration simplifies the process of mandatory confirmation of compliance with the established requirements for the manufacturer (seller) of drugs, and also increases his responsibility. After January 1, 2010, declaration of conformity is also provided for medical devices

12 12 Subject to declaration: Medicinal products manufactured by manufacturing enterprises in the territory of the Russian Federation; Medicinal products imported into the territory of the Russian Federation in accordance with the procedure established by the current legislation.

13 Declaration of Conformity - - a document certifying the conformity of products put into circulation with the requirements of technical regulations. The issued declaration of conformity is subject to registration by the body authorized by the federal executive body for technical regulation and standardization (Rosstandart). The declaration acquires legal force only after registration.

14 14 The form of the declaration of conformity of products with the requirements of technical regulations, as well as recommendations for filling it out, were approved by Order of the Ministry of Industry and Energy of the Russian Federation dated March 22, 2006 No. 54 “On approval of the form of a declaration of conformity of products with the requirements of technical regulations” .

The essence of the declaration Declaration of conformity is accepted by the declarant - the manufacturer himself or the seller (legal or individual, registered as an individual entrepreneur, or performing the functions of a foreign manufacturer on the basis of an agreement with him). When accepting the declaration, the declarant-manufacturer (supplier) declares that the product that he puts into circulation complies with the quality standards adopted in the Russian Federation. At the same time, he presents the necessary evidence (his own or with the participation of a third party).

Own evidence passport (analysis protocol) of the manufacturer (for domestic drugs); company quality certificate (for foreign drugs); documents confirming the origin of drugs; protocols of input control (tests) for raw materials, semi-finished products, substances and materials used in the production of drugs; documents confirming the origin of raw materials used in the production of this drug.

Evidence involving a third party 1. With the participation of an accredited testing center (test laboratory) : . test reports carried out according to the quality and safety indicators established in the regulatory documentation for this drug. 2. With the participation of the certification body: . certificates of conformity issued for production or quality system (QMS) certified in the Certification System.

18 Certification (184-FZ "On technical regulation") Certification is a form of confirmation of compliance of objects with the requirements of technical regulations, the provisions of standards, sets of rules or the terms of contracts "Certification" in Latin means "done right" carried out by the certification body. To know that a product is made correctly, one must have information about what requirements the product must meet and how to obtain proof of this conformity.

19 Certification body: - a legal entity or an individual entrepreneur duly accredited to perform certification work (certification centers for medicines and medical products). It carries out: confirmation of conformity, issues certificates of conformity (for medical devices), registration of declarations of conformity (for drugs, dietary supplements), grants applicants the right to use the mark of conformity with the national standard, suspends or terminates the certificates of conformity issued by them.

20 Certificate of conformity - - a document certifying the compliance of an object with the requirements of technical regulations, the provisions of standards, sets of rules or the terms of contracts.

21 The certification system is a set of: rules for performing certification work, participants, rules for the functioning of the certification system as a whole. (source: Federal Law "On technical regulation", art. 2)

22 22 What is subject to mandatory certification (Law of the Russian Federation "On Protection of Consumer Rights")? Goods (works, services) for which state standards establish requirements aimed at ensuring the safety of life, health of consumers and protection environment as well as to prevent damage to consumer property. Means that ensure the safety of life and health of consumers.

23 23 Powers of Accredited Centers for Certification and Quality Control of Medicines Quality Control Centers have the right to: carry out inspection control in relation to products certified by them once every 6 months (if it is provided for by the certification scheme); be involved by Roszdravnadzor to conduct an examination of the quality, safety and effectiveness of drugs on the basis of agreements with the federal service and its territorial bodies in accordance with the assignment received (general or specific); register declarations of conformity of product quality to established requirements in the presence of appropriate accreditation.

24 Unified All-Russian Register of Issued Certificates of Conformity and Registered Declarations of Conformity The Federal Executive Authority for Technical Regulation and Metrology (Rosstandart) maintains a unified all-Russian register of issued certificates of conformity and registered declarations of conformity. The register is formed on the basis of information provided by certification bodies.

25 25 Information for the consumer on the quality of medicinal products Documents REQUIRED for the sale of drugs: Declaration of Conformity; A copy of the declaration of conformity certified by the holder of the declaration; Shipping documents (including, for example, a register of certificates or declarations), certified by the signature and seal of the manufacturer (supplier, seller).

26 26 Necessary information on confirmation of conformity of the goods in the shipping documents: For medicines, MI, dietary supplements, PFT: Registration number of the declaration of conformity; Validity period of the declaration; Name of the manufacturer or supplier (seller) who accepted the declaration; Authority that registered the declaration. For other groups of goods: Number of the certificate of conformity; Its validity period; Authority issuing the certificate.

Mark of circulation on the market 27 designation that serves to inform purchasers about the compliance of products put into circulation with the requirements of technical regulations. The image of the sign of circulation on the market was established by Decree of the Government of the Russian Federation of November 19, 2003 No. 696. This sign is not a special protected sign and is applied for informational purposes (Article 27 of the Federal Law "On Technical Regulation" of December 27, 2002 No. 184 -FZ) . The sign of circulation on the market is a combination of the letters "T" (with a dot above it) and "P", inscribed in the letter "C", stylized as a measuring clamp, having the same height and width (4 options).

28 28 Mark of conformity - a designation used to inform purchasers about the compliance of the object of certification with the requirements of the voluntary certification system or the national standard

Sanitary and epidemiological conclusion, it is also a “hygienic certificate” - a document confirming that the products comply with the established hygienic standards (GN) and sanitary rules (San. Pi. N). The sanitary and hygienic certificate is issued by Rospotrebnadzor after an examination of products (production conditions, specifications) on the basis of a test report and submitted documents. The validity of the hygiene certificate is 5 years.

Products pharmacy assortment and documents confirming their quality Medicinal products Declaration of conformity Immunobiological preparations Certificate of conformity MIBP (IBLP) Biologically active additives Declaration of conformity (since 01. 2012) Registration certificate BAA + protocol for research on radionuclides Perfumery- cosmetics and oral care products Declaration of Conformity (Certificate of Conformity GOST R with reference to the sanitary and epidemiological conclusion) Spectacle lenses, frames, heating pads, ice packs, oilcloth Declaration of Conformity Dressings; MI; honey. technique; goods in contact with the human body Declaration of Conformity (Certificate of Conformity GOST R) Food additives, min. water, goods for children, hygiene products, etc. Sanitary and epidemiological conclusion (documents on the quality of the manufacturer) → 2 holographic signs on the copy

32 32 ACCREDITATION is the official recognition of the right of a quality control center or a testing laboratory to carry out specific tests or types of tests (recognition of technical competence, objectivity).

33 33 The list of testing laboratories (centers) accredited for testing medicinal products for the purpose of declaring their conformity includes more than 74 organizations various forms property

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7. Consideration of appeals

Conclusion

Sources of information

1. State system of quality control, efficiency, safety of medicines

To ensure the safety and effectiveness of drugs, they undergo state control, which is carried out in accordance with the Federal Law "On Medicines" No. 86-FZ.

Drugs are among the types of products that carry a potential hazard. This is because substandard or counterfeit medicines can be harmful to health. According to the Decree of the Government of the Russian Federation of April 29, 2002 No. 287, drugs were classified as products subject to mandatory certification. This List includes medicines, chemical-pharmaceutical products and products medical purpose.

From January 1, 2007, in accordance with the Decree of the Government of the Russian Federation No. 72 dated February 10, 2004 on mandatory certification of drugs, confirmation of their compliance with regulatory requirements was changed from a certificate of conformity to a declaration of conformity.

The procedure for the interaction of participants in the certification of drugs according to the previously existing (issuance of a certificate of conformity) and the new (registration of a declaration of conformity) system is shown in fig.

Certification of drugs is carried out by certification bodies (centers) accredited in the Drug Certification System on the basis of test reports issued by accredited testing laboratories.

In contrast to the mandatory certification procedure with the form of confirmation by a certificate of conformity, in which the conformity of products and services was confirmed by a third party - a certification body, a declaration of conformity is accepted exclusively by the first party, i.e. manufacturer, seller. A declaration of conformity registered with a certification body has the same legal force as a certificate of conformity.

General requirements for the procedure for mandatory certification of medicines are established by the Procedure for Certification of Products in the Russian Federation (Resolution of the State Standard of the Russian Federation of September 21, 1994 N 15) with Amendment N 1 of the Procedure for Certification of Products in the Russian Federation (Resolution of the State Standard of the Russian Federation of July 25, 1996 N 15 ); Rules for the use of the mark of conformity for mandatory certification of products (Resolution of the State Standard of the Russian Federation N 14 of July 25, 1996).

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

medicinal product certification identification

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

Bodies for the certification of medicines must use the test results issued by any testing laboratory accredited in the prescribed manner, in the event that the analysis is performed according to all indicators provided for by regulatory documents.

Certification of imported medicines is carried out according to the same rules and schemes as domestic products for compliance with the requirements of regulatory documents approved by the federal executive body in the field of healthcare. Certification of imported medicines can be carried out by a medicines certification body accredited in the Medicines Certification System of the GOST R Certification System.

“Mandatory certification is subject to drugs:

Produced by drug manufacturers in the territory of the Russian Federation;

Imported into the territory of the Russian Federation in the manner prescribed by the current legislation.

Groups of medicines that are not subject to mandatory certification are given in the Letter of the State Committee of the Russian Federation for Standardization and Metrology dated January 15, 2003 No. IK-110-25/110 "On Medicines Not Subject to Certification":

Medicinal products without individual packaging, not intended for retail sale;

Pharmaceutical substances for the production of medicines;

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

2. The procedure for certification of medicines

The procedure for certification of medicines includes

- submission of an application to the certification body;

- consideration of the application and the documents submitted by the applicant;

· - making a decision on the application, choosing a certification scheme;

- sampling;

- product identification;

· - testing;

· - certification of quality systems (production), if it is provided by the certification scheme;

· - analysis of the results of tests, inspections and decision-making on issuance (refusal to issue) a certificate of conformity;

- registration and issuance of a certificate of conformity;

· - implementation of inspection control over certified products (if it is provided for by the certification scheme);

· - corrective measures in case of violation of product compliance with established requirements and incorrect application of the mark of conformity;

· - information on certification results.

To carry out work on the certification of medicines, the applicant sends an application to the certification body.

The certification body considers the application and makes a decision on it no later than 3 days. Based on the results of consideration of the application, the certification body draws up and sends to the applicant a decision on the application.

Selection, identification of samples and their testing.

The number of samples, the procedure for their selection and identification rules are established in accordance with regulatory documents for the certification of medicines and test methods approved by the federal executive body in the field of healthcare.

Tests of medicinal products of domestic and foreign production during certification should be carried out only according to regulatory documents approved by the federal executive body in the field of healthcare (general pharmacopoeial articles, pharmacopoeial articles, pharmacopoeial articles of enterprises, regulations for medicinal products of foreign production).

The certification body carries out product identification in accordance with the requirements established by the federal executive authority in the field of healthcare. Identification is carried out: for belonging to the declared party; the legality of its production and sale (availability of a license); for compliance with documents confirming the origin of products and containing information about its quality and quantity; for compliance with the specified name and information indicated on the package, by evaluating the indicators "description", "packaging", "labeling".

3. List of documents required for identification of drugs

When identifying by the certification body, the following documents are considered

A copy of the license for the right to manufacture (sale) of medicines, certified by a notary;

The manufacturer's analysis protocol (for domestic medicinal products) or the company's analysis certificate and its translation (for foreign medicinal products) with the results of checking the quality of medicinal products for compliance with the requirements of regulatory documents upon release;

A document confirming the origin (acquisition) of medicines;

Documented information on the quantity of the medicinal product being certified.

The applicant, in order to reduce the period of work on certification, submits the documents considered during the identification of medicinal products simultaneously with the filing of the application.

If, based on the results of product identification, it is established that the product does not correspond to the declared name, accompanying documentation, description, packaging or labeling, the applicant is notified that further certification work is not performed.

Medicinal product samples are transferred by the certification body to the testing laboratory with an appropriate referral indicating the types of required certification tests and a copy of the drug sample (sampling) act.

Samples of medicinal products remaining from the testing are stored in the certification body for at least 6 months, after which medicinal products that meet the requirements of the regulatory document are transferred free of charge with the consent of the applicant to healthcare institutions or returned to the applicant with the execution of a transfer certificate, those that do not satisfy are destroyed with execution of the act of destruction. Requirements for marking and accounting of samples are established in the documents of the certification body.

The test results are drawn up in the form of a test report, which must reflect the actual data of the experimental verification, have a conclusion on compliance with the requirements of the regulatory document, and must be signed by the head of the testing laboratory. The test report in two copies is submitted to the certification body or, if the applicant applied directly to the testing laboratory in order to conduct tests on all indicators of regulatory documents, to the applicant. Test reports are subject to storage during the entire shelf life of the medicinal product.

4. Inspection control over certified products

Inspection control over certified products is carried out (if it is provided for by the certification scheme) during the entire validity period of the certificate once every 6 months in the form of periodic and unscheduled inspections, including testing of samples of medicines and other actions necessary to confirm that the manufactured and sold products continue to comply with the established requirements, confirmed during certification.

5. Stages of inspection control

Inspection control consists of the following stages:

Development of an inspection program;

Analysis of incoming information about certified products;

Sampling, testing and analysis of their results;

Registration of results of control and decision-making.

Unscheduled inspections are carried out in cases of receipt of information about claims to the quality of medicines from consumers, trade enterprises, medical institutions, as well as bodies exercising state control and supervision over products for which a certificate has been issued.

The results of inspection control are documented in an act. The act is stored in the certification body, and its copies are sent to the manufacturer (seller) and to the organizations that took part in the inspection control.

Based on the results of the inspection control, the certification body may suspend or cancel the certificate in case of non-compliance of medicinal products with the requirements of regulatory documents.

Information on the suspension or cancellation of the certificate is brought to the attention of the federal executive body in the field of healthcare, consumers and other interested participants in the certification system. The procedure and terms for communicating this information are established by the federal executive body in the field of health care.

Certification bodies send information on the results of certification and information on the conduct of inspection control to the central body of the System in a timely manner.

The provision of certification bodies and testing laboratories with regulatory documents is entrusted to the federal executive body in the field of healthcare.

6. Payment for certification work

Payment for certification of medicines is made by the applicant in accordance with the Certification Rules "Payment for Certification of Products and Services", approved by the Resolution of the State Standard of Russia of August 23, 1999 N 44, registered by the Ministry of Justice of Russia on December 29, 1999, registration N 2031.

7. Consideration of appeals

In the event of disputes and conflict situations between certification participants within the System, the interested party (s) may (may) file an appeal with the appeal commission of the federal executive body in the field of healthcare.

Decisions of the certification bodies, the appeal commission can be appealed in court in accordance with the established procedure.

The Declaration of Conformity is widely used in the countries of the European Union when confirming the conformity of products to European directives. The modular approach used in the EU in conformity assessment provides for the mandatory adoption by the manufacturer of a declaration of conformity, regardless of whether the manufacturer uses his own evidence or evidence of a third party (authorized body). Thus, the responsibility for the quality and safety of such products rests solely with the supplier of these products.

Introduced since January 1, 2007 in the Russian Federation, the procedure for declaring conformity for drugs includes a mandatory condition - confirmation (proof) by a third party. In this case, the third party is a duly accredited testing facility.

All drugs are subject to declaration of conformity, with the exception of drugs manufactured in pharmacies, drugs intended for clinical trials or registration in the prescribed manner.

Mandatory certification of drugs during its existence in both forms of conformity assessment has made it possible to significantly strengthen control over the circulation of drugs. Its implementation before the release of drugs on the market blocked the way for many low-quality drugs.

Conclusion

Along with the preparation of standards and the coordination of standardization work, the department considers important process putting standards into practice.

Thus, for systematic work on the creation of a system of regulatory documents in the field of drug supply and the introduction of standards into practice, it is necessary to coordinate and harmonize work on standardization both in the field of drug circulation and in healthcare in general. Specialized scientific institutions and the broad pharmaceutical and medical community should take an active part in this work.

Sources of information

Sh Elizarova T.E. Modern methods of standardization and quality control of medicines. - M.: MIA, 2008

Sh http://lektsii.org/8-54393.html

Sh http://docs.cntd.ru/document/901820418

Ш https://www.audit-it.ru/articles/account/otrasl/a90/43676.html

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Declaring procedure

The general principles for declaring the conformity of product quality to requirements are determined by the Federal Law of December 27, 2002 No. 184-FZ "On Technical Regulation".

Who is authorized to issue a declaration of conformity?

The manufacturer himself or a representative of a foreign manufacturer of products declares the compliance of the drug with the standards and requirements. At the same time, a legal entity or an individual entrepreneur must have the appropriate powers of attorney and permits, in particular a license to conduct pharmaceutical activities. In essence, this is the main difference between the declaration of conformity and product certification.

If, when declaring conformity to quality, the manufacturer himself declares and subsequently proves this by research and testing, then during certification, the responsibility for asserting the proper quality of products lies entirely with the authorized body.

What confirms and on the basis of what is it accepted?

The declaration is a certificate confirming the safety and quality of the medicinal product launched in the implementation for the population. More specifically, the document confirms the compliance of the medicinal product with pharmacopoeial articles of various levels.

According to the regulatory framework, confirmation of the conformity of the drug is established on the basis of the evidence of the declarant - the manufacturer of the product and the evidence of a third party - a research laboratory duly accredited for such tests.

How is it carried out?

The declaration is issued for a Russian manufacturer or a foreign importer. For foreign manufacturers, the procedure is not provided. First of all, the declarant relies on his own evidence of product compliance with the requirements of quality standards. These include:

manufacturer's passport for a Russian drug or a quality certificate for a foreign one;
document on the origin of the medicine;
testing and research, certificates of conformity of raw materials and semi-finished products, materials used in production.

In addition, the declaration is based on studies and test reports carried out by the relevant laboratories and research centers with the appropriate authorization and accreditation.

The document may be issued for a separate batch or batch of the drug. The validity period is set by the declarant. It should be borne in mind that when declaring a separate batch, the validity period cannot exceed the shelf life of the product.

Who is authorized to test products?

As already mentioned above, in order to prove the conformity of products with the requirements of standards, the manufacturer may involve a third party, which will be a testing laboratory or center. Institutions are required to be accredited to conduct drug trials.

Which authorities register the certificate?

The medicinal product can enter circulation in the territory of the country and be sold only after registration of the declaration of conformity. Registration is carried out by an accredited certification center.

The list of companies that have the proper approvals is given in the appendix to the letter of the Federal Service for Supervision in Health and Social Development dated July 30, 2010 N 04I-755/10. Roszdravnadzor provided a list of seven centers authorized for registration.

The declarant sends an application to the certification center with a request for registration, with a declaration and documents confirming the accuracy of the information indicated in it. The application is submitted to only one accredited organization.

The text of the declaration is typed on a sheet of A4 paper without any distinguishing marks. The declaration contains: the name of the declarant, information about him - registration and contact details, last name, first name, patronymic of the head, in whose person the organization operates.

Next, the name of the product and information about the batch or series of release are indicated, and then it is declared to the requirements of which standards the drug complies with and on the basis of which documents this is approved. The registration date and validity period are set.

The finished document is signed by an authorized person of the organization, that is, a director or official representative of a foreign company, and submitted for registration.

What documents do you need to provide?

In addition to the above-mentioned statements, declarations and documents confirming the quality of products (both from the manufacturer itself and laboratory test reports), the following must be attached to the application package:

What will be checked?

Verification of the submitted documents is carried out within seven days. To approve the registration, the certification body examines the information provided about the declarant, the medicinal product and the compliance of the drug with the requirements of regulatory documentation.

In addition, the correctness of filling out the declaration, the validity period, the availability and compliance of the information contained in the State Registration Register with the information provided in the application is established.

What is the successful result and what to do in case of failure?

If the results of the check are satisfactory, the certification center makes an appropriate entry in the register of registered declarations. In the document itself, a mark is made on the date of registration, the center that carried it out.

If registration is refused for one reason or another, a reasoned response is sent to the declarant indicating the identified inconsistencies with the requirements. After elimination, the application can be re-submitted to the same certification authority.

Do drugs need to be labeled and how exactly?

After successful registration, the medicinal product must be labeled with a quality conformity mark. The application of the sign is carried out by the center that accepted the declaration, or by a person authorized by the declarant. The sign can be applied both to the packaging of the drug and to the accompanying documents. At the same time, the declaration itself does not apply to them.

For failure to apply the appropriate sign, administrative liability is provided in the form of a fine., the amount of which, in accordance with clause 2 of article 19.19 of the Code of Administrative Offenses of the Russian Federation, is from 1000 to 2000 rubles.

How is quality control carried out by Roszdravnadzor?

Federal Service for Surveillance in the Sphere of Health and social development authorized by the legislator to carry out control measures in health care and social development. One of the main tasks of the executive authority and territorial subdivisions is to check the circulation of medicines on the territory of the Russian Federation.

Control is carried out in three possible ways:

Selective examination of medicines in civil circulation. To carry out the procedure, the body has the right to involve third-party independent organizations, such as quality centers.
Continuous monitoring of drug quality and safety.
Inspections.

In case of detection of substandard drugs, the products are withdrawn from circulation and destroyed.

Will the procedure be cancelled?

On January 27, 2018, a bill was submitted to the State Duma to abolish the certification of medicines, that is, to exclude products from the list of Government Decree No. 982. According to parliamentarians, declaration is an unnecessary bureaucratic procedure.

In accordance with the bill, before releasing the first three batches of products for sale, the manufacturer sends information confirming the quality of the drug to Roszdravnadzor.

Despite the public outcry, the project for certification was adopted by the State Duma, and on November 23, 2018 it was approved by the Federation Council.

The further fate of maintaining the legality of products on the retail market of medicines remains vague. By abolishing the procedure for certification and declaration of quality, the legislator seeks to strike a balance between optimizing the admission of drugs to the market and checking their quality. The success of such an initiative will be determined by time.

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

The first step in the process of bringing a product to the market of the Russian Federation is its registration. Registration is a state examination of the quality, efficacy and safety of a drug for the purpose of subsequent approval of the medical use of the drug in the Russian Federation.

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

Registration of medicines.

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

The Ministry of Health and Social Development of Russia has formed a separate Department for State Regulation of the Circulation of Medicines, which is responsible for the registration of new and circulation of already registered medicines.

In 2010, the drug registration procedure 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 entered into force on September 01, 2010. To date, 4 amendments 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.

Normative legal acts regulating the procedure for registration of medicines:

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

The procedure for registration of foreign and Russian drugs is the same.

The registration procedure consists of 4 consecutive stages:

Preparation of the registration dossier, including the documents required to get started clinical trial, and submitting a dossier to the Ministry of Health and Social Development of Russia.
Obtaining permission to conduct a clinical trial and its conduct in the Russian Federation.
Examination of the quality of the medicinal product and examination of the ratio of the expected benefit to the possible risk of using the medicinal product, carried out after its clinical trial: The third stage can be divided into 2 sub-stages:
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 ratio of the expected benefit to the possible risk of application and approval of the Instructions for medical use drug.
Adoption of the decision of the Ministry of Health and Social Development of Russia on the inclusion of the drug in the State Register of Medicines and the issuance of a registration certificate.

Registration deadlines

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

Registration of medical devices

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

The procedure for the registration of medical devices is regulated by the "Administrative Regulations of the Federal Service for Supervision in the Sphere of Health and Social Development for the provision public service on registration of medical devices, as well as providing citizens and organizations with access to information about registered medical devices”

Normative base:

Draft Federal Law "On Medical Devices".
Order of the Ministry of Health and Social Development of the Russian Federation of October 30, 2006 N 735 "On Approval of the Administrative Regulations of the Federal Service for Supervision in Health and Social Development for the implementation of the state function of registering medical devices."
Decree of the Government of the Russian Federation of September 15, 2008 N 688 "On approval of the lists of codes for medical goods subject to value added tax at a tax rate of 10 percent."
Order of the Federal Service for Supervision in the Sphere of Healthcare and Social Development dated November 09, 2007 N 3731-Pr / 07 "On approval of the nomenclature classifier of medical devices and medical equipment (medical devices)".
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 conclusions or state registration certificates must be issued during customs clearance."
State registration of medical devices is carried out by Roszdravnadzor on the basis of positive results relevant tests (research) (technical, toxicological, clinical), as well as positive conclusions expert commissions on examinations of the quality, efficacy and safety of medical devices.

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

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

State registration food additives and cosmetics

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

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 of October 19, 2007 N 657 “On approval of the Administrative Regulations of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare for the performance of the state function of state registration of first introduced into production and previously unused chemical, biological substances and drugs manufactured on their basis, potentially dangerous to humans (except for medicines); certain types of products that pose a potential hazard 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 Supervision of Consumer Rights Protection and Human Welfare dated July 19, 2007 N 224 "On sanitary and epidemiological examinations, surveys, studies, tests 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 conclusions 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 the lists of codes for medical goods subject to value added tax at a tax rate of 10 percent."
Order of the Federal Service for Supervision of Consumer Rights Protection and Human Welfare of July 19, 2007 N 224 "On sanitary and epidemiological examinations, surveys, studies, tests and toxicological, hygienic and other types of assessments."

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

After receiving the Certificate of State registration it is necessary to go through procedures for confirming the quality of the product in the form of certification or declaration.

Certification and declaration

Each product sold in Russia must comply with 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 compliance of the certified product with the necessary quality and safety requirements established for this product by the 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 released by him 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 that have passed the declaration procedure have official proof of a high level of quality, and as a result, inspire consumer confidence.

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