Examine Substance Profile

Study of data with methods
of control of similar molecules

Testing of control methods
proposed by the manufacturer

Compiling a registration dossier

Submission of registration dossier
to the regulatory authority

Accompanying until
adding to the State Register

 

Pharmaceutical substance is a substance that is used by specialists for the production of medicines. According to the current regulations, substances of foreign origin must be registered in the established order before they are applied on the territory of the Russian Federation.

 

The process of entering the register of pharmaceutical substances is provided for by Federal Law No. 61-FZ of April 12, 2010. This procedure is carried out in an approved manner and requires the collection of the necessary package of documents. To pass it successfully in the shortest possible time, it is recommended to use the services of specialized companies that have the necessary experience of carrying out similar procedures

 

Required package of documents

To complete the procedure, you must provide the following required documents:

 

  • Statement of the customer on the possibility of adding the substance to the register.
  • Documents on payment of duties and other mandatory payments.
  • Documents describing the technology of manufacturing the product to be registered.
  • Paper, which confirms the compliance of production conditions with the quality requirements of medicinal products. It must be issued by an authorized state body of another country, translated into Russian and legalized in accordance with the established procedure.
  • Official papers, in which there are data on the quality parameters of the substance being recorded.
  • Normative documents for substance. Samples of the substance for quality control and the substances used in this process

 

The entering procedure consists of four steps:

  1. Provision of collected for registration.
  2. Examination in the Federal State Budgetary Institution.
  3. Analysis of the findings of the examination in the Ministry of Public Health.
  4. Entering into an open database  

 

Where to order the service

 

Do you need to register a pharmaceutical substance? Apply for help to the Center "Promedika". We carry out the following types of work for customers:

 

  • reparation of proposals on the possibility of registration of a substance in the Russian Federation. The customer receives a report, which calculates the cost of the procedure and its duration.
  • Formation of the registration dossier, which contains the documents required for registration.
  • Submission of the registration dossier to the authorized state bodies and its accompaniment during the whole procedure of entering the substance into the state register.
  • Development of analytical methods in laboratory conditions.
  • Organization of import of a substance into the territory of the Russian Federation with the provision of assistance in customs clearance of products.
  • Transfers of documents for registration of a substance from a foreign language to Russian with subsequent notarization and legalization in accordance with the established procedure.

 

After completion of the work, the substance is entered in the open register, available on the website of the Ministry of Public Health of the Russian Federation. Issuance of a document confirming registration is not provided by law. The registered substance is kept in the register indefinitely.

 

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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