Is this procedure mandatory in the Russian Federation? Certification of medicines Certified medicines.

Confirmation of compliance of drugs with the requirements imposed by current legislation is mandatory.

The Government of the Russian Federation approved (Resolution of the Government of the Russian Federation dated December 1, 2009 No. 982 (as amended on October 20, 2014):

• · Unified list of products subject to mandatory certification;
• · A unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity.

According to this document confirmation of compliance in the form subject to mandatory certification:

· medical immunobiological preparations;

Confirmation of conformity in the declaration form are subject to drugs registered in the prescribed manner and consisting of mixed or unmixed products for therapeutic use, packaged in dosage form dosage forms or in packaging for retail sale (codes 931000-937000 of the All-Russian Product Classifier OK 005-93).

The following are not subject to declaration:

• · Medicines manufactured in pharmacies according to doctors’ prescriptions and requirements medical organizations;
• · in-pharmacy preparation;
• · drug substances intended for carrying out clinical trials;
• · substances intended for drug registration.

Declaration of Conformity- this is a document certifying the compliance of products released into circulation with the requirements of technical regulations (Federal Law of the Russian Federation No. 184 “On Technical Regulation”).

The declaration process involves the participation of 3 parties:

• · certification body,
• · accredited testing laboratory,
• · declarant (manufacturer or supplier).

Today in the Russian Federation there are 7 drug certification bodies accredited in accordance with the established procedure (4 in Moscow, St. Petersburg, Yekaterinburg, Novosibirsk), which register declarations of conformity and about 70 technically competent and independent testing laboratories accredited to conduct drug testing for the purposes of declaration of conformity.

When confirming compliance in the declaration form, the Declarant independently:

• · selects a testing laboratory and certification body that registers declarations of conformity;
• · carries out the selection of samples for examination (or may entrust the selection of samples on a contractual basis to a testing laboratory or certification body).

The declaration of conformity of drugs is accepted by the manufacturer or seller himself (legal or an 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 manufacturer (supplier) declares that the product it puts into circulation meets the quality standards adopted in the Russian Federation. At the same time, he presents the necessary evidence.

Types of evidence:

• · own evidence:
  • 1. passport (analysis protocol) of the manufacturer (for domestic drugs);
  • 2. company quality certificate (for foreign drugs);
  • 3. documents confirming the origin of the medicine;
  • 4. protocols of incoming control (testing) for raw materials, intermediate products, substances and materials used in the production of drugs;
  • 5. documents confirming the origin of the raw materials used in the production of this drug.
• evidence involving a third party:
• - with the participation of an accredited testing laboratory: test reports carried out according to the quality and safety indicators established in the regulatory documentation for this drug;
• - with the participation of the certification body: certificates of conformity issued for production or quality management system (QMS), certified in the GOST R Certification System.

The declaration of conformity of a drug accepted by the manufacturer (seller) is subject to registration with a certification body accredited in the prescribed manner. Registration is of an application nature. The declaration of conformity must have two seals - the seal of the certification body and the seal of the organization for which the declaration is issued. The register of registered declarations of conformity is maintained by the certification body. The declaration of conformity can be sent for registration to only one certification body at the choice of the manufacturer (seller). medicinal pharmacy quality pharmaceutical

A declaration of conformity is accepted for each series (batch) of drugs released into circulation. The Declaration of Conformity is accepted for the period established by the manufacturer (seller) of the drug, but not longer than the established shelf life of the drug. Providing copies of declarations of conformity is not provided. Information about the declaration of conformity is indicated in the accompanying documentation for the product.

Currently, in accordance with Art. 28 Federal Law No. 184-FZ “On Technical Regulation” establishes the obligation of persons who are applicants (seller of products) to present to interested parties documents confirming the conformity of products with established requirements (declarations of conformity or copies thereof). At the same time, interested parties may be Centers for quality control and certification of drugs in the constituent entities of the Russian Federation, wholesale pharmaceutical organizations, retail pharmacy organizations, as well as consumers.

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 products medical purposes 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. license to provide medical and pharmaceutical activities;
  2. certification of 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;
• decor 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 experts high level 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 are issued for medical supplies only by authorized certification centers accredited in this area. 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 issuing a GOST R certificate of conformity or other certificates right now necessary documents products, you can contact us for professional assistance. 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.

Send your good work in the knowledge base is simple. Use the form below

Students, graduate students, young scientists who use the knowledge base in their studies and work will be very grateful to you.

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GBPOU RME "Yoshkar-Olinsky Medical College"

"Drug Certification"

Completed by a student of group FM-21:

Gazizova Ramilya

Checked:

Kalagina T.Yu.

Yoshkar-Ola

7. Consideration of appeals

Conclusion

Information sources

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

To ensure safety and effectiveness, drugs undergo state control, which is carried out in accordance with Federal law“On Medicines” No. 86-FZ.

Medicines belong to types of products that carry potential danger. This is because low-quality or counterfeit medicines can be harmful to health. According to the Decree of the Government of the Russian Federation dated April 29, 2002 No. 287, drugs were classified as products subject to mandatory certification. This List includes medicines, chemical-pharmaceutical products and medical products.

From January 1, 2007, in accordance with the Decree of the Government of the Russian Federation No. 72 of 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 interaction between participants in drug certification according to the previously existing (issuance of a certificate of conformity) and the new (registration of a declaration of conformity) system is presented in Fig.

Medicines are certified by certification bodies (centers) accredited in the Medicines Certification System on the basis of test reports issued by accredited testing laboratories.

Unlike the mandatory certification procedure with a form of confirmation by a certificate of conformity, in which the conformity of products and services was confirmed by a third party - the certification body, the 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 Russian Federation(Resolution of the State Standard of the Russian Federation dated September 21, 1994 N 15) with Amendment No. 1 of the Procedure for Certification of Products in the Russian Federation (Resolution of the State Standard of the Russian Federation dated 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 No. 14 of July 25, 1996).

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

medicine certification identification

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

Certification bodies for medicines must use test results issued by any testing laboratory accredited in the prescribed manner, if 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.

“The following drugs are subject to mandatory certification:

Medicines produced by 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 medicinal products 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 medicinal products not subject to certification”:

Medicines without individual packaging, 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).”

2. Procedure for certification of medicines

The procedure for certification of medicines includes

· - submission of the application to the certification body;

· - consideration of the application and 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 provided for by the certification scheme;

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

· - registration and issuance of a certificate of conformity;

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

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

· - information about certification results.

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

The certification body reviews 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 on the certification of medicines and test methods approved by the federal executive body in the field of healthcare.

Testing of medicinal products of domestic and foreign production during certification should be carried out only in accordance with regulatory documents approved by the federal executive body in the field of healthcare (general pharmacopoeial monographs, pharmacopoeial monographs, pharmacopoeial monographs of enterprises, regulations for foreign-made medicines).

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

3. List of documents required for drug identification

When identifying, the certification body considers the following documents:

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

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

A document confirming the origin (purchase) of medicines;

Documented information about the quantity of the certified medicinal product.

In order to reduce the period of certification work, the applicant submits the documents considered for the identification of medicinal products simultaneously with the submission of the application.

If, based on the results of product identification, it is determined 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 carried out.

Samples of medicinal products are transferred by the certification body to the testing laboratory with the appropriate direction indicating the types of required certification tests and a copy of the certificate of sampling of medicinal products.

Samples of medicinal products remaining from 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 a transfer certificate, those that do not satisfy are destroyed with execution of an act of destruction. Requirements for labeling and recording of samples are established in the documents of the certification body.

The test results are documented in the form of a test report, which must reflect the actual data of the experimental test, 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 to conduct tests on all indicators of regulatory documents, to the applicant. Test reports must be stored for the entire shelf life of the medicinal product.

4. Inspection control of certified products

Inspection control over certified products is carried out (if 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 products produced and sold continue to meet 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;

Selection of samples, testing and analysis of their results;

Registration of control results and decision-making.

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

The results of inspection control are documented in an act. The certificate 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 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 about the suspension or cancellation of a 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 deadlines for providing this information are established by the federal executive body in the field of healthcare.

Certification bodies send to central authority The system provides information on certification results and information on inspection control in a timely manner.

Providing certification bodies and testing laboratories with regulatory documents is the responsibility of the federal executive body in the field of healthcare.

6. Payment for certification work

Payment for work on certification of medicines is made by the applicant in accordance with the Certification Rules “Payment for work on certification of products and services”, approved by 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

Whenever controversial issues And conflict situations between certification participants within the System, the interested party(s) may file an appeal to the appeal commission of the federal executive body in the field of healthcare.

Decisions of certification bodies and 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 to confirm product compliance with European Directives. The modular approach used in conformity assessment in the EU requires the manufacturer to accept a declaration of conformity, regardless of whether the manufacturer uses its own evidence or evidence from a third party (notified body). Thus, responsibility for the quality and safety of such products rests solely with the supplier of these products.

The procedure for declaring conformity for drugs, introduced on January 1, 2007 in the Russian Federation, includes required condition- confirmation (proof) by a third party. IN in this case the third party is a duly accredited testing agency.

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

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

Conclusion

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

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

Information sources

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

Ш http://lektsii.org/8-54393.html

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

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

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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 quality 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 intended purpose 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 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: