Preparation of a registration dossier, documents for starting a clinical study,
and passing the dossier to the Ministry of Health and Social Development of Russia

Obtaining permission to conduct
clinical research and conduct it in the Russian Federation.

Examination of medicine's quality and examination of the relationship
of the expected benefits to the possible risk of the use of medicine

Decision-making by the Ministry of Health and Social Development of Russia
on the inclusion of the drug in the State Register of Medicines

Issue of Registration Certificate

The issuance of a new medicine in the market of Russia is possible only after passing its official registration. This procedure involves checking the quality of the new medicine, as well as determining its effectiveness to treat various pathologies and harmlessness to the human body.

 

Necessity and rules for registration of medicines are fixed by the current legislation (№61-FZ from April 12, 2014), as well as by branch subordinate acts.

 

The process of registration of medicines is sufficiently formalized, it requires the filing of a large number of different official papers and compliance with a variety of requirements. For its successful passage it is recommended to use the help of professionals.

 

Would you like to order a registration of medicines? Use the help of the Center "Promedika". Our specialists have a great experience in carrying out similar works and are ready to provide you with assistance at any stage of the procedure. Thanks to us you will be able to register medicines in the shortest time, with minimal costs and guarantee of the result (in compliance with the requirements of the legislation of Russia).

 

What drugs are subject to registration

The process of issuing a permit for pharmaceutical products includes the following steps:

  • original medicines developed on the territory of our country or abroad;
  • reproduced remedies for various pathologies;
  • new combinations of medicines and components that more effectively treat certain diseases;
  • drugs that have been registered with a change in their form or dosage.
  • State registration of medicines is not necessary if they are manufactured by pharmacies according to the approved formulation, contain components of exclusively plant origin or imported into Russia in a small amount solely for their own needs.

 

How are medicines registered?

 

The process of issuing a permit for pharmaceutical products includes the following steps:

 

1. Formation of a technical dossier for the procedure. It consists of administrative papers, a description of the registered drug, including information on the procedure for its production and the procedure for quality control. In addition, the package of documents should contain data on the study of the drug (preclinical and clinical).

2. The package of documents is provided in the state language, if necessary, foreign papers are translated with obligatory certification by a notary and legalization in the consulate or with the apostille stamp.

3. Clinical studies in Russia. This requirement is stipulated by the current legislation on the development and registration of medicines (No. 61-FZ). The procedure is mandatory, except for the cases when the analogue of the medicine is already available in the Russian Federation for more than 20 years, and, at the same time, it is not possible to undergo the procedure for determining bioequivalence

The scope of the test depends on the type of drug, the method of taking it, the pharmacological group, the number and nature of the tests conducted abroad and some other factors. If the preclinical studies were not conducted in our country, they should not be transferred to the territory of the Russian Federation. It is enough to provide the necessary reports.

Before the tests you need to get permission for them. For this purpose, a full registration dossier is sent to the Ministry of Public Health and an application is submitted.

Before the end of the tests, conducted only in a specialized medical center with accreditation, the registration process is suspended. Time of work execution - from 6 months to 1.5 years.

Quality control of the medicine and the ratio of predicted benefit to potential risk. It is carried out after the completion of the phase of clinical testing. The procedure of inspection (examination) implies the study of methods of quality control of the drug. For this, a batch of medicines is imported on the basis of the issued import permit. Examination of the expected benefits is carried out by the experts of the Federal Public Health Service of the Russian Federation Ministry of Public Health on the basis of the data provided. Based on the results of the research, the Instruction on the use of the medicine can be modified.

4. After passing the above procedures, the medicines is entered in the register on the basis of clinical research and examination data, which is confirmed by the issuance of the Registration certificate. If a negative decision is taken, the applicant is given a document fixing the refusal in the state registration

The first certificate has a 5-year validity period. After that documents are submitted for confirmation of registration. The next certificate is valid for an unlimited period of time.

 

Registration services

The Center for Clinical Studies "Promedika" provides qualified assistance in preparing the package of documents and passing the state registration of medicines until the receipt of the necessary permits (registration certificate).

 

In addition, you can use these services:

 

  • Entering in the register of pharmaceutical substances.
  • Development of mock-ups and labeling of medicines and their registration in state bodies.
  • Formation of the dossier required for the registration procedure.
  • Translation, notarization and legalization of documents required for registration of medicinal products.

 

For the primary analysis (scheme), cost and timing of registration of funds (LS),
Medical products (MI) and dietary supplements according to the rules of the Russian Federation
and the United Arab Emirates the manufacturer must provide the following data:

Medicine

1. Instructions for use


2. Detailed composition


3. Certificate copyGMP


4. Data on pre-clinical and clinical trials


5. The status of product registration in the country of production



Medical product

1. Description of the medical device


2. Copy of ISO certificate, CE certificate (or other similar documents)


3. Data on pre-clinical and clinical trials


4. The status of product registration in the country of production

 



BAA

1.Instructions for use


2. Full composition with percentage of components


3. A copy of the GMP certificate and / or ISO and / or HACCP


4. Data on pre-clinical and clinical trials


5. A copy of the safety certificate for product

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