State registration of medicinal products

In accordance with Paragraph 1 of Article 13 of the Federal Law of April 12, 2010№ 61-FZ "On circulation of medicinal products", "the medicinal products are introduced into civil circulation in the territory of the Russian Federation if they are registered by the appropriate authorized federal body of executive power".

Authorized federal executive body governing the issues of registration of medicinal products is the Ministry of Health of the Russian Federation. The Department of state regulation of the medicinal products circulation of the Ministry of Health is involved in the registration of new products and circulation of already registered medicinal products.

The following categories of MP shall be subject to state registration:
1) The original medicinal products;
2) reproduced medicinal products;
3) new combinations of previously registered medicinal products;
4) medicinal products that are registered earlier, but produced in other dosage forms, the new dosage.

The data of a registered medicinal product, including the pharmaceutical substance, which is a part of the medicinal product, are included in the National Register of medicines, and the Registration certificate of the medicinal product is issued to an applicant of state registration, as well as the Decisionon the inclusion of the pharmaceutical substance in the National Register of medicines.

In accordance with Article 28 of the Federal Law of the Russian Federation of April 12, 2010 № 61-FZ "On circulation of medicinal products", "registration certificate of the medicinal product indicating dosage forms and dosage is issued termless, except for the registration certificate of the medicinal product issued with a five years validity, to medicinal products first recordedin the Russian Federation".

Upon the expiration of five years a termlessregistration certificate of medicinal product shall be issued, subject toconfirmation of its state registration.

The procedure of registration of medicines consists of several stages:

Stage I. Preparation of documents for the formation of the registration dossier, including the documents required to obtain permission to conduct clinical trial of the medicinal product, filing the registration dossier to the Ministry of Health and Human Development of the Russian Federation.

Stage II. Obtaining permission to conduct clinical trial (for medicinal products approved for medical use in the Russian Federation for less than 20 years), conducting clinical trial.

Stage III. Expertise of the quality of the medicinal product and examination of the rate of expected benefit to the possible risk of medicinal product use, carried out after the clinical trial of the medicinal product:
- Quality control of medicinal product in the authorized Laboratory Center and approval of the regulatory document;
- Expertise of the rate of the expected benefit to the possible risk of the application and approval of the Basic Prescribing Information for the medicinal product.

Stage IV. Adoption by the Ministry of Health and Social Development of Russia of decision to include the medicinal product in the National Register of medicinal products and filling out of the registration certificate.


Our provides the following services for registration of medicinal products:


Customer consultation on the registration of medicines;
Preparing a plan for the registration and list of required documents;
Adaptation of the documentation provided by foreign partners, to the requirements of the Russian Federation;
Development of regulatory documents for medicinal products;
Development of Basic Prescribing Information of medicinal products;
Preparing layouts of primary and secondary packaging;
Working out methods of analysis;
Development of composition and production technology of the dosage forms;
Formation of a registration dossier;
Submission of registration dossier to the authorized federal executive body carrying out state registration of medicines (Ministry of Health and Social Development of the Russian Federation);
The organization and conducting of preclinical studies;
The organization and conducting of clinical trials;
The organization and conducting of bioequivalence studies;
The organization and conducting of studies of comparative antimicrobial activity of antibiotics;
The organization and conducting of a comparative kinetics of dissolution test;
Maintenance of the registration process;
Obtaining permits, decisions and official requests of the authorized federal executive body carrying out state registration of medicines;
Preparation of additional materials as requested by the authorized federal executive body carrying out state registration of medicines;
Obtaining a Registration certificate and approved documentation (regulatory document, Basic Prescribing Information, packaging layouts) for the medicinal product.
Amending to documents contained in the registration dossier for the registered medicinal product

In accordance with Paragraph 1 of Article 30 of the Federal Law of the Russian Federation of April 12, 2010 № 61-FZ “On the circulation of medicinal products”, “in order to amending to documents contained in the registration dossier for the registered medicinal product for medical use, the applicant shall submit to the authorized federal executive authority of an application about such amendments in the form prescribed by the authorized federal body of executive power, and the attached amendments to these documents, as well as documents confirming the necessity for such changes”.

The document confirming the amendments to the documents contained in the registration dossier for a registered medicinal product, is a decision to amend the documents contained in the registration dossier to the registered medicinal product.

The Part 2 of Article 30 of the Federal Law of April 12, 2010 № 61-FZ “On circulation of medicinal products” provides several options for amending to the documents contained in the registration dossier for the registered medicine:
1) with the expertise of the medicinal products within the expertise of the quality of the medicinal product intended for medical use;
2) expertise of the medicinal products within the expertise of the ratio of the expected benefit to the possible risks of the medicinal product intended for medical use;
3) expertise of medicinal products within the quality assessment of medicinal product and expertise of the ratio of expected benefit to the possible risk of use of the medicinal product intended for medical use;
4) without expertise of medicinal products.

Amendments that require the expertise of the medicinal product:

in case of amendments to the Basic Prescribing Information of the medicinal product in relation to the information specified in paragraphs “г” – “п”, “x” in paragraph 16 of Part 3 of Article 18 of the Federal Law of April 12, 2010 № 61-FZ “On circulation of medicinal products”;

in case of amendments to the composition of the medicinal product intended for medical use;

in case of amendments to the place of manufacture of the medicinal product for medical use;

in case of amendments to quality characteristics of the medicinal product for medical use and (or) quality control methods of the medicinal product for medical use;

in case of amendments to the expiration date of the medicinal product for medical use.

The procedure for amending to the documents contained in the registration dossier for a registered medicinal product, consists of several basic stages:

Stage I. Preparation of documents, forming a package of documents.

Stage II. Submission to the Department of State regulation of the medicinal products circulation of the Ministry of Health and Social Development of the application to amend the documents contained in the registration dossier for a registered medicinal product, and a generated set of documents.

Stage III. Receiving the decision on sending to the expert institution of the task to carry out the expert examination of the medicinal product.

Stage IV. Examination of the medicinal product.

Stage V. Decisions on amendments to the documents contained in the registration dossier for a registered medicinal product.

our provides the following services to amend the documents contained in the registration dossier to the registered medicinal product:

Customer consultation on amendments to the documents contained in the registration dossier of a registered medicinal product;

Preparing a plan for amendments to documents contained in the registration dossier for a registered medicinal product and a list of required documents;

Adaptation of the documentation provided by foreign partners, to the requirements of the Russian Federation;

Development of projects of normative documents (statement of amendments to the standard documentation) for medicines, taking into account the amendments;

Development of Basic Prescribing Information of medicinal products (statement of amendments to the Basic Prescribing Information), taking into account the amendments;

Preparing layouts of primary and secondary packaging, taking into account the amendments;

Creating a package of documents to amend the documents contained in the registration dossier of a registered medicine;

Submission of set of documents to the authorized federal executive body carrying out state registration of medicines (Ministry of Health and Social Development of the Russian Federation);

Support of the process of amending to the documents contained in the registration dossier of a registered medicinal product;

Obtaining permits, decisions and official requests of the authorized federal executive body for carrying out amendments to the documents contained in the registration dossier of a registered medicinal product;

Preparation of additional materials as requested by the authorized federal executive body carrying out amendments to the documents contained in the registration dossier of a registered medicinal product;

Receiving decisions on amendments to the documents contained in the registration dossier for the registered medicinal product, and approved statements to amendments in the regulatory document, Basic Prescribing Information, layout of packages for the medicinal product, taking into account the amendments.

Obtaining termless Registration certificate and the approved documentation (normative documents, Basic Prescribing Information, packaging layouts) of the medicinal product.

      

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