Home Dental treatment Documents submitted to Roszdravnadzor to confirm the quality of a medicinal product, pharmaceutical substance, biological material or other substance in the composition of medicines. Is this procedure mandatory in the Russian Federation? Confirm the fact of drug certification

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Documents submitted to Roszdravnadzor to confirm the quality of a medicinal product, pharmaceutical substance, biological material or other substance in the composition of medicines. Is this procedure mandatory in the Russian Federation? Confirm the fact of drug certification

The main tools for ensuring the quality of medicinal products in the distribution chain are drug certification and assessment of their conformity.

Certification- this is an activity to confirm the compliance of products with the norms, rules, and characteristics established during the standardization process.

In accordance with the Law of the Russian Federation “On the Protection of Consumer Rights”; Law of the Russian Federation “On certification of products and services”; Decree of the Government of Russia dated August 13, 1997 No. 1013 “On approval of the List of works and services subject to mandatory certification"; Decree of the Government of Russia dated April 29, 2002 No. 287 “On amendments to the List of goods subject to mandatory certification and to the List of products whose compliance can be confirmed by a declaration of conformity”; the “Certification System” was developed and approved medicines GOST R certification systems". The basic rules and requirements related to the procedure for certification of domestic and foreign-made drugs registered in Russia are determined by the “Rules for certification in the Certification System of Medicines of the GOST R Certification System”, approved by Resolution of the State Standard of Russia dated May 24, 2002 No. 36 and put into effect with 12/15/2002.

Certification (in translation from Latin - “done correctly”) can be mandatory or voluntary. The mandatory certification mechanism also provides for confirmation of compliance through acceptance Declaration of Conformity.

Declaration of Conformity is a document in which the manufacturer (seller, performer) certifies that the products supplied (sold) by him meet the established requirements.

The declaration of conformity, adopted in the prescribed manner, is registered with the certification body and has legal force on par with the certificate.

Since October 1, 2004, in accordance with the Decree of the Government of Russia dated February 10, 2004 No. 72, drugs have been excluded from the list of goods subject to mandatory certification. By Decree of the Government of Russia dated April 29, 2006 No. 255 “On amendments to Decree of the Government of the Russian Federation dated February 10, 2004 No. 72,” from January 1, 2007, certification of drugs is replaced by a declaration of conformity.

The circulation of drugs on the Russian pharmaceutical market is carried out only after registration of a declaration of conformity of the drug with the requirements of regulatory documents (general pharmacopoeial monographs, pharmacopoeial monographs, pharmacopoeial monographs of enterprises, regulatory documents for drugs of foreign production).

A declaration of conformity of a drug can be accepted for a specific series of drugs. The declaration is accepted by the declarant on the basis of his own evidence and evidence obtained with the participation of a third party, which is accepted as: test reports conducted in an accredited testing laboratory (center), or certificates of conformity for production or quality system of the GOST R Certification System.

Process declaration different from the process certification the fact that the certification body itself selected both drug samples for examination and the testing laboratory, applied and received an examination conclusion and, as a result, issued a certificate of conformity. In case of confirmation of conformity in the form of a declaration, the applicant selects both a testing laboratory and a certification body that registers declarations of conformity. He can either independently select samples for examination or entrust the selection of samples on a contractual basis to a testing laboratory or certification body. A prerequisite for sampling is compliance with the requirements of regulatory documents, drawing up a sampling report and submitting it to the testing laboratory.

The Declaration of Conformity contains the following information:

· name and location of the applicant for the declaration of conformity or the holder of the registration certificate for the medicine;

· name and location of the manufacturer (manufacturers);

· name of the drug, its dosage form and dosage;

· active substances and their quantity per dose unit;

· drug state registration number;

· number of the produced series;

· date of manufacture;

· number of consumer packages in a series;

· an indication that the declaration of conformity is carried out on the basis of one’s own evidence, indicating the date and number of the analysis protocol;

· shelf life of the drug series;

· signature of an authorized person.

The registered declaration of conformity of the drug, together with the documents on the basis of which it was accepted, is kept by the declarant for at least three years after the expiration of its validity period.

Certificate of conformity of quality systems (production) - a document certifying that the quality system (production) of the drug declared by the manufacturer meets the established requirements.

Certificate of conformity of the medicinal product- a document certifying the compliance of the drug with all the requirements of regulatory documents, issued in the drug certification system.

A uniform certificate of conformity for a drug is issued by drug certification authorities after checking the drug for compliance with the requirements of regulatory documents approved by the Ministry of Health of Russia for the applicant.

The certificate is valid upon delivery or sale of a batch of products during the shelf life of the drug established by regulatory documents. Medicines in circulation as of April 1, 2007 and having a certificate of conformity issued in the prescribed manner are not subject to declaration (Resolution of the Government of Russia dated November 28, 2006 No. 810).

Inspection control of certified products (if provided for by the certification scheme) is carried out during the entire validity period of the certificate, at least once every 6 months in the form of periodic and unscheduled inspections, including drug testing and other checks necessary to confirm that the products being manufactured and sold continues to meet the established requirements confirmed during certification.

In the case of wholesale trade of drugs, information on confirmation of the conformity of the drugs sold is presented in the form of transfer from the seller to the buyer of a copy of the certificate of conformity, certified in accordance with the rules established by the Government. Russian Federation order or the original declaration of conformity. On the reverse side of the copy of the certificate of conformity, a record is made of the sale of the goods, indicating information about the buyer and the quantity of goods sold. The original certificate of conformity (a copy certified in the prescribed manner) is kept by the holder of the original (certified copy) until the expiration of the certificate of conformity.

In retail trade, the seller has the right to bring to the attention of the consumer information about confirmation of drug compliance with established requirements using one of the following documents:

· certificate of conformity or declaration of conformity;

· a copy of the certificate of conformity, certified by the holder of the original certificate, a notary or the certification body that issued the certificate;

· commodity accompanying documents prepared by the manufacturer or supplier (seller), containing for each product name information on confirmation of its compliance with the established requirements (number of the certificate of conformity, its validity period, the body that issued the certificate, or registration number declaration of conformity, its validity period, the name of the manufacturer or supplier who accepted the declaration, and the body that registered it), and certified by the signature and seal of the manufacturer (supplier, seller) indicating his address and telephone number.

In addition, in accordance with clauses 71 and 72 of the “Rules for the sale of certain types of goods”, approved by Decree of the Government of the Russian Federation No. 55 in 1998, information about drugs and medical devices must contain information about state registration Medicines indicating the number and date of its state registration (with the exception of extemporaneous medicines). Information about medical devices should contain, taking into account the characteristics of a particular type of product, information about its purpose, method and conditions of use, action and effect, restrictions (contraindications) for use. This information is usually contained in certificates of conformity, which are issued after state registration and contain information about its number and date in the “Bases” section. In accordance with OST 91500.05.0007-03, all deliveries of goods must be accompanied by documents allowing to establish: date of shipment, name of the drug (including dosage form and dosage), series and batch number, quantity of goods supplied, price of the drug supplied, name and address of the supplier and buyer, as well as documents confirming quality.

Documents confirming the quality of medical equipment are:

· registration certificate;

· sanitary and epidemiological conclusion;

· and certificate of conformity.

For glasses (except for sunglasses) - a declaration of conformity.

For biologically active additives for food (dietary supplements) - a certificate of quality and safety (for each batch) and a sanitary-epidemiological conclusion (copy) for a period of 5 years, and for a pilot batch for 1 year (previously a registration certificate was issued for 3 years or 5 years). A new dietary supplement requires a certificate of state registration of new food products, materials and products, perfumery and cosmetic products.

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:

These Rules define the basic principles and requirements related to the certification procedure for domestic and foreign-made medicines registered in the State Register in order to protect the rights and interests of consumers and pursue a unified state policy in the field of providing the population with high-quality medicines.

II. The procedure for mandatory certification of medicines

1. General requirements to the procedure for mandatory certification of medicines are established by the Procedure for carrying out certification of products in the 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 carrying out 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).

2. 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.

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.

3. 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.

4. 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.

5. The procedure for certification of medicines includes:

Submitting an application to the certification body;

Review 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;

Carrying out 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.

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

7. 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.

8. Selection, identification of samples and their testing.

8.1. 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).

8.2. The selection of samples for testing is carried out by the certification body or a competent organization authorized by the central body.

8.3. Samples are taken at the applicant's warehouse in the quantity necessary to conduct 3 analyzes for all indicators provided for by regulatory documents.

8.4. The selection of samples is documented in an act. Selected samples are isolated from the main products, packaged, sealed or sealed at the sampling site. The release of selected samples (samples) of medicinal products is formalized in accordance with the procedure established by the enterprise.

8.5. 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”.

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.

8.6. 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.

8.7. 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 for the purpose of conducting tests on all indicators of regulatory documents, to the applicant. Test reports must be stored for the entire shelf life of the medicinal product.

8.8. If the quality of medicinal products does not comply with the requirements of regulatory documents, the testing laboratory sends a conclusion with a test report to the certification body for medicinal products and the federal executive body in the field of healthcare.

The storage period for test reports of medicinal products, the quality of which does not meet the requirements of regulatory documents, is established for testing laboratories by the federal executive body in the field of healthcare, but cannot be less than 6 months.

Information about the identification of non-compliance of a medicinal product with the requirements of a regulatory document during certification is sent by the medicinal product certification body to the applicant, to the federal executive body in the field of healthcare, with the submission of a test report.

In cases where testing laboratories cannot assess the quality of medicinal products in accordance with the requirements of this document, it is recommended that samples of these medicinal products with accompanying documents be sent to the institute state control medicines. Samples of medicinal products are sent for testing in the quantity necessary to carry out 3 analyzes for all indicators provided for by regulatory documents, including testing for microbiological purity, with a covering letter, a sample collection report, an original or a certified copy of the analysis protocol carried out by the manufacturer.

8.9. The certification body, after identifying products, analyzing test reports, certifying the quality (production) system (if established by the certification scheme) and analyzing the submitted documents, assesses the compliance of medicinal products with regulatory documents. The test results must fully and reliably confirm the product’s compliance with the requirements of regulatory documents.

Reducing the volume of tests (controlled indicators of regulatory documents) of medicines produced by domestic manufacturing enterprises and foreign manufacturing companies, and which have no complaints about the quality of the products, is allowed only in agreement with the federal executive body in the field of healthcare.

The results of this assessment are reflected in the expert’s report. Based this conclusion The certification body decides to issue a certificate of conformity, issues the certificate and registers it.

If the results of the conformity assessment of medicinal products are negative, the certification body issues a reasoned decision to refuse to issue a certificate.

9. Inspection control of certified products

9.1. 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.

9.2. 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 control results and decision-making.

9.3. 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.

9.4. 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.

9.5. 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.

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

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

Trade secret.

3. The drug certification body maintains a registration and recording system in working order. Registration records must reflect the certification procedure for medicines.

4. The medicines certification body keeps records of the certificates it issues in the prescribed manner and sends information about them to the Central Medicines Certification Body.

5. The maintenance of the register of certified medicines is carried out by certification bodies, which send the relevant information to the Central Authority for maintaining a consolidated register of certified medicines in the Russian Federation.

IV. Testing laboratories

1. Testing laboratories (centers) accredited in the established manner, regardless of their organizational and legal forms and forms of ownership, that meet the established requirements and are independent of the manufacturer (seller) and consumer (buyer) are allowed to carry out testing of medicinal products for certification purposes.

2. The activities of testing laboratories in the field of certification of medicines are carried out on the basis of accreditation certificates issued in the prescribed manner.

3. The testing laboratory tests medicines of domestic and foreign production in strict accordance with the requirements of regulatory documents approved by the federal executive body in the field of healthcare.

V. Consideration of appeals

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

2. Decisions of certification bodies and the appeal commission may be appealed in court in the prescribed manner.

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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 products medical purposes.

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 carrying out certification of products in the 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 carrying out 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 the medicinal product certification authorities 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.

medicine certification identification

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 incorrect application of the conformity mark;

· - 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.

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;

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.

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.

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.

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

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

If controversial issues and conflict situations arise 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 accordance with the established procedure.

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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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.