Researcher's brochure

Protocol of clinical research

Individual registration card

The form of informed consent (ICF)

Clinical trial report

Literature review

 

All medicines that are first put into circulation on the territory of our country, as well as new combinations of existing medicines or drugs issued in new forms or dosage, are subject to compulsory registration in state bodies. This requirement is stipulated by Law No. 61-FZ of April 12, 2010

State registration is conducted in a strictly established procedure and requires the provision of a compulsory package of documents. Based on this, an examination is carried out, which gives an opinion on the possibility or impossibility of using a medicine to treat pathologies in the territory of the Russian Federation.
 

Order of registration of documents

Two years ago, the regulatory legal acts of the Russian Federation regulating the process of issuing permits for the use of medicines have been amended, according to which the registration dossier for a registered medicine is submitted in the form of a so-called general technical document

Amendments to the federal legislation require the presence of a Russian GMP certificate in the single file. This is a copy of the conclusion of the Ministry of Industry of the Russian Federation on the compliance of the manufacturer of the medicine with the requirement.

If it is necessary to register several dosage forms, the above single technical dossier is compiled for each of them. If the dosage form has several dosages or concentrations, the filing of different dossiers for processing permits for each of them is not required
 

The dossier for registration of medicine includes documents distributed in several sections:
 

  • Official administrative papers
  • Documents confirming data on active ingredients and substances that are used in the manufacture of the medicine.
  • Description of the medicinal properties of the registered pharmaceutical preparation.
  • Data describing the process of medicine quality control.
  • Information about the preclinical studies of the medicine.
  • Data on clinical trials of the medicine.
  •  

In addition, the owner of the Registration certificate for the medicine provides Federal Service for Supervision in Health Care with periodic reports on the use of the medicine after registration:

  • Once in six months for the next two years.
  • Once a year for the next three years.
  • Every five years throughout the life of the medicine.  

All submitted documents must be stated in Russian or translated from a foreign language with mandatory certification and legalization in accordance with the established procedure. Legalization can be carried out in the following ways:

  • Seal of an apostille or consular organization (papers issued by state bodies).
  • Seal and signature of the official of the manufacturer (documents issued by the manufacturer)
  • Seal and signature of the authorized laboratory person who conducted the test (for clinical and preclinical test results).
     

Documents that describe the process of checking quality, certification and production can be provided in the form of copies.

 

Assistance in the preparation of medical documentation

Do you need to prepare documents for registration of the medicine in Russia? Apply for help to the Center "Promedika". We offer our clients the following services:
 

  1. Preparation of documents for the formation of the registration dossier.
  2. Support services for OTD throughout the process of obtaining permission to use the medicine in Russia.
  3. Preparation of the list of documents required for registration of the drug.
  4. А Adaptation of documents issued by foreign companies and state bodies, as well as bringing them in line with the requirements of the current Russian legislation.
  5. Assistance in preparing separate names of documents that should be part of the registration dossier.

 

Do you want to use the help of the "Promedika" Center to prepare medical documentation? Please contact our specialists by the telephone number listed on the website.

 

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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