Home Tooth pain Regulatory documents confirming the quality of medicines. Documents submitted to Roszdravnadzor to confirm the quality of a medicinal product, pharmaceutical substance, biological material or other substance in the composition of medicines

Regulatory documents confirming the quality of medicines. Documents submitted to Roszdravnadzor to confirm the quality of a medicinal product, pharmaceutical substance, biological material or other substance in the composition of medicines

Under the current legislation, medicines are subject to mandatory certification through the procedure of declaring the drug's conformity with the requirements and standards established in the country.

Certification of medicines in Russia was first introduced in 1994 with the adoption of Order of the Ministry of Health No. 53, which prescribes control over each series of drugs produced medicines.

In the modern legal field, the Decree of the Government of the Russian Federation of December 1, 2009 is in force. No982 “On approval of a unified list of products subject to mandatory certification and a unified list of products, confirmation of conformity of which is carried out in the form of a declaration of conformity.” Until 2007, according to the regulatory legal act, medicines were subject to mandatory certification.

In 2007, drugs were excluded from this list and included in the list of products, the quality of which is confirmed by adopting an appropriate declaration.

In the field of mandatory certification there remain:

  • immuno- and gammaglobulins;
  • serums and blood-based preparations;
  • complex biological substrates resulting from discoveries and developments of genetic engineering;
  • the certificate is also issued for toxoids, toxins and vaccines.

However, Some exceptions are also made from the list of medicines subject to declaration. According to the text of the letter of the State Standard of the Russian Federation dated January 15, 2003 N IK-110-25/110 “On medicinal products not subject to certification”, there is no need to declare quality:

  • Medicines without individual packaging, so-called “in bulk” drugs. Products are supplied pharmaceutical companies who carry out the final packaging and packaging of drugs. Thus, “in bulk” does not enter the retail market, but remains a kind of intermediate product. After completing the packaging process, the drug goes through the declaration stage.
  • Pharmaceutical substances. The situation is almost similar to the previous example. The products are used pharmaceutically. companies for the production and release of a completed and ready-to-sell drug, which undergoes a quality control procedure.
  • Immunobiological preparations, vaccines and serums, the types of which are not included in the Government's list.

Declaration procedure

The general principles for declaring compliance of product quality with requirements are determined by the Federal Law of December 27, 2002 No. 184-FZ “On Technical Regulation”.

Who has the right to accept the declaration of conformity?

The manufacturer or a representative of a foreign manufacturer of the product declares the drug’s compliance with the standards and requirements. In this case, a legal entity or individual entrepreneur are required to 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 quality conformity, the manufacturer himself declares and subsequently proves this through research and testing, then during certification, responsibility for asserting the proper quality of the product lies entirely with the authorized body.

What does it confirm and on what basis is it accepted?

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

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

How is it carried out?

The declaration is issued on Russian manufacturer or foreign importer. The procedure is not provided for foreign manufacturers. 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 quality certificate for a foreign one;
  • document on the origin of the medicine;
  • testing and research, certificates of conformity of raw materials and intermediate products, materials used in production.

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

The document can be issued for a separate batch or series 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 has the right to test products?

As already mentioned above, to prove the product’s compliance with the requirements of the 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?

A medicinal product can go into circulation in the country and be sold only after registering a declaration of conformity. Registration is carried out by an accredited certification center.

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

The declarant sends an application to the certification center with a request for registration, attaching a declaration and documents confirming the accuracy of the information specified 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 distinctive signs. The declaration contains: the name of the declarant, information about him - registration and contact information, 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 production series are indicated, and then it is declared what standards the drug meets and on the basis of what 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 I need to provide?

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


What will be checked?

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

In addition, the correctness of filling out the declaration, its validity period, the availability and compliance of the information contained in the GRLS with the information provided in the application are established.

What is a successful outcome and what to do if it fails?

If the results of the inspection are satisfactory, the certification center makes a corresponding entry in the register of registered declarations. The document itself contains a note about the date of registration and 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 non-compliance with the requirements. After elimination, the application can be resubmitted to the same certification authority.

Do drugs need to be labeled and how exactly?

After successful completion registration requires marking medicinal product quality mark. The mark is applied by the center that accepted the declaration or by a person authorized to do so by the declarant. The mark can be applied both to the packaging of the drug and to accompanying documents. However, the declaration itself does not apply to them.

Failure to apply the appropriate sign will result in administrative liability 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, ranges from 1000 to 2000 rubles.

How is quality control carried out by Roszdravnadzor?

Federal Service for Surveillance in Healthcare and social development authorized by the legislator to carry out control measures in healthcare and social development. One of the leading tasks executive body authorities and territorial divisions - checking the circulation of medicines on the territory of the Russian Federation.

Control is carried out in three possible ways:

  1. 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.
  2. Constant monitoring of the quality and safety of drugs.
  3. Inspections.

If substandard drugs are discovered, the products are withdrawn from circulation and destroyed.

Will the procedure be cancelled?

On January 27, 2018, a bill was introduced to the State Duma to cancel the certification of medicines, that is, to exclude products from the list of Government Resolution 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 obvious public outrage, the project has been accepted for certification State Duma, and on November 23, 2018 it was approved by the Federation Council.

The future fate of maintaining the legality of products on the retail drug market remains unclear. By abolishing the certification and quality declaration procedure, the legislator seeks to strike a balance between optimizing the access of drugs to the market and checking their quality. Time will determine the success of such an initiative.

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1. Confirmation state registration of the medicinal product is carried out upon issuance of an unlimited registration certificate of a medicinal product in the case specified in Part 2 of Article 28 of this Federal Law, within a period not exceeding sixty working days from the date of receipt by the relevant authorized federal body executive power applications for confirmation of state registration of a medicinal product. Confirmation of state registration is not carried out in relation to a medicinal product that has not been in circulation. Russian Federation for three or more years, as well as in relation to a medicinal product produced in violation of the requirement established by part 3.7 of Article 71

2. Application for confirmation of state registration of a medicinal product for medical use is submitted to the relevant authorized federal executive body no earlier than one hundred and eighty days before the expiration of the registration certificate of the medicinal product for medical use.

(see text in the previous edition)

2.1. An application for confirmation of state registration of a medicinal product for veterinary use is submitted to the relevant authorized federal executive body no earlier than one hundred and eighty days before the expiration of the registration certificate of the medicinal product for veterinary use and no later than the expiration of its validity.

3. Confirmation of state registration of a medicinal product is carried out based on the results of an examination of the ratio of expected benefit to possible risk use of a medicinal product based on the results of monitoring the effectiveness and safety of the medicinal product carried out by the holder or owner of the registration certificate of the medicinal product or authorized by them legal entity, as well as the relevant authorized federal executive body in accordance with the requirements of Article 64 of this Federal Law.

4. The following shall be attached to the application for confirmation of state registration of a medicinal product for medical use:

1) documents containing the results of monitoring the effectiveness and safety of a medicinal product for medical use, carried out by the holder or owner of the registration certificate of a medicinal product for medical use or a legal entity authorized by it, in a form approved by the authorized federal executive body;

2) a copy of the license for the production of medicinal products or a copy of the conclusion on the compliance of the medicinal product manufacturer with the requirements of the rules of good manufacturing practice issued by the authorized federal executive body in relation to the production site of a medicinal product for medical use, the state registration of which is confirmed if the production of the medicinal product is for medical use is carried out in the Russian Federation;

3) a copy of the license issued by the authorized body of the country of manufacture for the production of a medicinal product for medical use and its translation into Russian, certified in the prescribed manner, as well as a copy of the conclusion on the compliance of the medicinal product manufacturer with the requirements of the rules of good manufacturing practice, issued by the authorized federal executive body in in relation to the production site of a medicinal product for medical use, the state registration of which is confirmed, or a copy of the decision of the authorized federal executive body to conduct an inspection of the manufacturer of medicinal products if the production of the medicinal product for medical use is carried out outside the Russian Federation.

(see text in the previous edition)

4.1. In relation to biological medicinal products for medical use, the applicant additionally presents the results of the measures provided for in the risk management plan approved by the authorized federal executive body when carrying out state registration of the medicinal product for medical use.

4.2. The application for confirmation of state registration of a medicinal product for veterinary use is accompanied by documents containing the results of monitoring the effectiveness and safety of the medicinal product for veterinary use, carried out by the holder or owner of the registration certificate of the medicinal product for veterinary use or a legal entity authorized by him, in a form approved by the authorized federal body executive power, and the documents specified in paragraphs 1, - 2.2, subparagraphs “a”, “b”, “k”, “l” of paragraph 4 of part 3 of article 17 of this Federal Law. In relation to immunobiological medicinal products for veterinary use, the information specified in subparagraph “k” of paragraph 4 of part 3 of Article 17 of this Federal Law is not provided. In relation to medicinal products for veterinary use obtained with the use of genetically modified organisms or containing such organisms, the information specified in paragraph 13 of part 3 of article 17 of this Federal Law is additionally provided.

(see text in the previous edition)

4.3. With an application for confirmation of state registration of a medicinal product, the applicant submits a copy of the document confirming payment of the state fee for confirmation of state registration of the medicinal product, or may submit the specified document on his own initiative. In case of failure to submit the specified document, the authorized federal executive body verifies the fact of payment of the state duty by the applicant by using information on the payment of the state duty contained in the State Information System on State and Municipal Payments, based on the copy of the document submitted by the applicant confirming the payment of the state duty.

5. Within ten working days from the date of acceptance of the application for confirmation of state registration of the medicinal product and documents containing the results of monitoring the effectiveness and safety of the medicinal product carried out by the holder or owner of the registration certificate of the medicinal product or a legal entity authorized by them, the authorized federal executive body:

1) checks the completeness of the information contained in the documents submitted by the applicant;

2) makes a decision to conduct or refuse to conduct an examination of the relationship between the expected benefit and the possible risk of using the medicinal product based on the results of monitoring the effectiveness and safety of the medicinal product, carried out by the holder or owner of the registration certificate of the medicinal product or a legal entity authorized by them, as well as the federal executive body authorities in accordance with the requirements of Article 64 of this Federal Law;

3) notifies the applicant and the expert institution in electronic form or in writing about the decision taken or if a decision is made to refuse to conduct an examination, indicate the reasons for such refusal.

6. If it is revealed that the information contained in the documents submitted by the applicant is unreliable and (or) insufficient, the authorized federal executive body sends the applicant a request to clarify the specified information. The request of the authorized federal executive body may be submitted to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels. If a request from an authorized federal executive body is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

7. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding ninety working days from the date of its receipt. The period specified in Part 5 of this article is suspended from the day the request is sent to the applicant by the authorized federal executive body until the day it receives the corresponding response and is not taken into account when calculating the period for confirming the state registration of the medicinal product.

8. The basis for refusal to conduct an examination of the relationship between the expected benefit and the possible risk of using a medicinal product is the submission of documents containing the results of monitoring the effectiveness and safety of the medicinal product, and (or) in relation to biological medicinal products, the results of the implementation of measures in accordance with the risk management plan approved by the authorized federal executive body when carrying out the state registration of a medicinal product, incompletely, the absence of information confirming the fact of payment of the state duty for confirmation of the state registration of the medicinal product, or the applicant’s failure to provide a response within the prescribed period to the request of the authorized federal executive body specified in Part 6 of this article authorities, as well as the lack of information in these documents that should be reflected in them.

9. An examination of the ratio of the expected benefit to the possible risk of using a medicinal product in order to confirm the state registration of the medicinal product is carried out by a commission of experts of an expert institution within a period not exceeding forty working days.

10. If the materials provided to the expert are insufficient to give an opinion, the expert applies to the head of the expert institution to provide him with necessary materials. The head of the expert institution submits a corresponding request to the authorized federal executive body that issued the assignment to conduct an examination of the relationship between the expected benefit and the possible risk of using the medicinal product on the basis of a document containing the results of monitoring the effectiveness and safety of the medicinal product. Within five working days from the date of receipt of the request from the head of the expert institution, the specified federal executive body sends the applicant a request to provide the necessary materials, which can be transferred to the authorized representative of the applicant in person against signature, sent by registered mail or transmitted electronically via telecommunication channels . If a request from an authorized federal executive body is sent by registered mail, it is considered received after six days from the date of sending the registered letter.

11. The applicant is obliged to submit a response to the request of the authorized federal executive body within a period not exceeding sixty working days from the date of receipt of the specified request. The authorized federal executive body that issued the assignment to conduct an examination of the relationship between the expected benefit and the possible risk of using a medicinal product on the basis of a document containing the results of monitoring the effectiveness and safety of the medicinal product, within five working days from the date of receipt from the applicant of a response to the request of the authorized federal executive body the authorities forward this response to the expert institution. If, after sixty working days, the applicant fails to provide a response to the specified request, the authorized federal executive body that issued the assignment to conduct an examination of the relationship between the expected benefit and the possible risk of using the medicinal product on the basis of a document containing the results of monitoring the effectiveness and safety of the medicinal product, within five working days days sends a notification to the expert institution about the applicant’s failure to provide a response to the request of the specified body. The time from the date of sending the request of the expert institution to the authorized federal executive body until the day the expert institution receives a response to the request or notification of failure to provide a response to the request is not taken into account when calculating the period for conducting an examination of the ratio of the expected benefit to the possible risk of using a medicinal product on the basis of a document containing the results monitoring the effectiveness and safety of the drug.

13. The basis for refusal to confirm the state registration of a medicinal product is the conclusion of the relevant authorized federal executive body that the risk of harm to human or animal health as a result of taking the medicinal product exceeds the effectiveness of its use.

(see text in the previous edition)

14. During the procedure for confirming the state registration of a medicinal product, its circulation in the Russian Federation is not suspended.

15. It is allowed to circulate medicinal products before the expiration date, produced within one hundred and eighty calendar days after the date of the decision by the authorized federal executive body to confirm state registration, in accordance with the information contained in the documents of the registration dossier for the medicinal product before the date of such decision.

(see text in the previous edition)

Counterfeiting of drugs in modern pharmaceuticals is not uncommon. By purchasing a low-quality medicine, the consumer will not only not get rid of the existing disease, but may very likely become poisoned. How to protect yourself from buying a fake? One of the most reliable options in in this case There will be a check to see if the medicinal product has a certificate of conformity.

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

You can only talk about the quality of medicines if you have four types of certification documents:

  • Certificate of conformity. This version of the permit document confirms the compliance of the quality of medicines with the requirements of GOST;
  • The registration certificate allows you to sell medicines on the territory of all constituent entities of the Russian Federation;
  • Production certificate - confirms the fact that in the process of manufacturing drugs in pharmaceutical production, quality control is carried out in accordance with established requirements;
  • Certificate medicinal product, which confirms its quality for the purpose of further export from the country.

IN modern conditions Russian market quality control and certification of medicinal products have great value. The rise in prices of drugs leads to the intensification of their handicraft production and an increase in the level of falsification. The need to obtain certificates for medicinal products also arises because the proportion of defects in pharmaceutical production has greatly increased.

When purchasing drugs at a pharmacy, the consumer has every right ask for a sanitary and epidemiological report. It is imperative to obtain a certificate for medicinal products imported into Russia from abroad.

You can obtain a permit for medications from the ACM certification center only if the sample test results obtained in an accredited laboratory meet the quality requirements.

The procedure for obtaining a certificate for any type of medicinal product is as follows:

  • The manufacturer submits an application to our certification center;
  • Responsible and qualified employees organizations analyze the application and submitted documents;
  • Next is compiled detailed diagram certification;
  • In the laboratory, a thorough check of samples of medicinal products provided by the manufacturer is carried out;
  • The research results and technical documentation are analyzed;
  • Employees of the certification center make a decision on issuing permits for medicines or refusing them;
  • Carrying out the procedure for issuing a certificate;
  • Inspection certified medicines, already put into circulation;
  • Performance correctional work aimed at bringing finished medicinal products to the required standards.

If you want to quickly and efficiently obtain a certificate of conformity for medicinal products, contact for help. Our specialists will do everything possible to ensure that you short term were able to obtain the necessary permits. The employees of our certification center have been preparing documents for pharmaceutical products for a long time. By contacting us by phone, you can receive comprehensive information regarding certification of medicines . We are ready to provide you with qualified assistance in obtaining a certificate of conformity for any types of pharmaceuticals.

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

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

According to Rules No. 36:

“The following medicinal products are subject to mandatory certification:

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

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

Groups of 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”:

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

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

- pharmaceutical substances for the production of medicines;

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

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

Medicine quality certificate- a document confirming the conformity of the quality of the medicinal product state standard quality of medicines (Article 4 of Law No. 86-FZ);

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

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

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

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

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

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

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

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

In case of receiving production organization certificate of conformity for manufactured products that we have:

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

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

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

The organization has an invoice in its hands.

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

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

Note!

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

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

Description of service

Is it mandatory to obtain certificates for medicines?

Medicines or drugs- these are drugs of natural or synthetic origin, or a mixture of several types of substances. Used for the prevention, diagnosis or treatment of diseases. They are usually produced in the form of tablets, suspensions, powders or liquids. In Russia, mandatory certification is provided for medicines. It applies to all medicines that are included in the unified list of goods subject to declaration. This procedure assumes that the quality and safety of medicinal products will be confirmed through laboratory examinations, drawing up protocols and filing a declaration of conformity. If mandatory certification is not carried out, the production and distribution of medicines on the territory of the Russian Federation will be considered illegal. If there are no certificates of compliance of medicinal products with GOST norms and standards, the manufacturer will be held liable, provided for by laws RF.

Why is voluntary certification of drugs and medicines needed?

In order to increase the competitiveness of products in the domestic market, to make their product more attractive to consumers, and to gain additional benefits when participating in tenders and competitions, many entrepreneurs strive, in addition to mandatory confirmation of conformity, to issue voluntary quality certificates for medicinal products. Such a document will be the main guarantee of high quality and safety of products. You can buy it on your own initiative, in order to increase demand, consumer confidence and profits. Competent and interested in the success of their business, manufacturers receive this certificate, declaring for examination those characteristics that they themselves consider necessary. At the same time, the price of this procedure will justify itself soon. Astels LLC specialists will help you complete the certification procedure quickly, professionally and in accordance with the law!

How to obtain a quality certificate for medicines in Moscow?

The Astels Center for Standardization and Expertise has long been cooperating on certification issues with companies in Moscow and other cities of the Russian Federation. We do not sell services, but provide professional assistance and assistance in the field of permitting documentation. Astels offers a wide range of services and various forms cooperation on certification issues. Cooperation with us will open up additional opportunities for your business and help save time and money. We value our reputation, therefore we carefully follow all requirements established by the state. If you have set yourself the task of purchasing a quality certificate for any goods or services, then we are looking forward to seeing you! Are you interested in cooperation? Find out the cost of our services, or get more detailed information by calling Consulting company Astels toll-free number 8-800-70-70-144.



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