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Development of the registration dossier, registration


Certification and licensing according to the requirements of the EAEU (Eurasian Economic Union)

The registration dossier for a medicinal product must be developed in accordance with the requirements of the Eurasian Economic Union (EAEU) and include the following sections:

The registration dossier

The registration dossier for a medicinal product must be prepared and submitted in accordance with the requirements of the EAEU and must contain all the necessary information about the medicinal product. It must be submitted in the language of the EAEU member country where the drug will be registered.

Registration of medicines according to the requirements of the EAEU takes place in accordance with the unified rules for registration and evaluation of medicines approved by the Commission of the EAEU.


To register medicines in the EAEU, you must submit the following documentation:


Registration of drugs

Registration of drugs is an important step in order for these drugs to be available on the market and can be used to treat various diseases. In the countries of the Eurasian Economic Union (EAEU), which include Russia, Belarus, Kazakhstan, Armenia and Kyrgyzstan, the registration of medicines is carried out according to uniform requirements. In accordance with the requirements of the EAEU, the drug registration process includes several stages. At the first stage, a study and evaluation of the safety and efficacy of the drug is carried out. Then the application for registration takes place, which consists of several documents, including a description of the drug, the results of clinical trials, and data on the efficacy and safety of the drug.

Next comes the stage of examination of the application for registration, which is carried out by specialists in the field of pharmacology and clinical medicine. This allows you to evaluate all aspects of the drug, including its safety, efficacy and quality. If the application for registration has passed the examination successfully, then the drug can be registered and receive a marketing authorization. It is important to note that the registration of medicines according to the requirements of the EAEU is mandatory for all manufacturers who wish to sell their medicines on the market of these countries.

This ensures a high level of drug safety and efficacy, and discourages the sale of unsafe or insufficiently effective drugs. In general, the registration of drugs according to the requirements of the EAEU is a complex but important process that ensures the availability of high-quality drugs on the market and protects people's health.


To register medicines according to the requirements of the EAEU, you must complete the following steps:

In case of successful registration, the medicinal product receives permission for sale in the territory of the EAEU member countries.

After the submission of full documentation for the registration of a medicinal product in the EAEU, it is registered and a permit is issued for its sale in the territory of the EAEU member countries.

Certification of a production site according to GMP (Good Manufacturing Practice) requirements is a process of assessing and confirming the compliance of production processes and conditions for the production of medical products (drugs, medical devices, food additives) with international GMP standards.

GMP certification of a manufacturing site includes verification of compliance with the requirements established in the governing documents (for example, European Pharmacopoeia, FDA, PIC/S), as well as verification of compliance with legal and regulatory requirements in the country where the site is located.

Certification is carried out by independent experts or organizations accredited to conduct such assessments. After passing the certification check, the production site is issued a GMP certificate of conformity, which guarantees that the products manufactured at this site meet high quality and safety standards.

The production of medicines in Russia is possible only at factories that have a valid GMP certificate issued by the Ministry of Industry and Trade of the Russian Federation.

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