Analysis of available materials, audit of materials
registration dossier for compliance with EAEU requirements

Services for validation, development and writing of documentation,  The
included in the registration dossier

Accompanying at all stages of the registration process

 

Normative acts and international agreements of Russia, regulating the turnover of medicines on the territory of the country, require the drafting of the medicine in accordance with the standards of the EEU. This requirement applies to all medicines registered before these changes are introduced into the legislative acts of the Russian Federation. To bring the documents in line with international requirements, the time is given until the end of 2025.


The essence of the requirement is that the holder of the registration certificate for the medicines must submit the documents in the dossier in such a way that they correspond to the standard adopted by the EEU. It is necessary to do this in such a way that no new information is introduced into it reflecting the quality, safety of the use of the medicine and the effectiveness of its use.

The procedure for processing the dossier in accordance with the requirements of the EEU differs depending on the states in which the applicant has already registered the drug, and on whether it is necessary to evaluate the use of the drug and the risk of its use or not.


By the time the process takes a bit more than three months plus the time required to receive responses to the sent international requests.

 

 

The order for passing the procedure in the states where the medicine was registered


This option is possible if the medicine already has a registration in the country entering into the union. If the applicant has it in several countries, then one reference is chosen.


The process itself is conducted according to the scheme of registration under the procedure of mutual recognition.

You must provide:

  • Application of the holder of the Registration certificate.
  • Receipts for payment of state duty.
  • New registration dossier.

In the latter, only the first 3 modules are required to comply with the rules of the EEU. The next two, where the results of the tests (preclinical, clinical) are described, need not be changed.
 

In the process of carrying out the procedure, the state body of the country where registration was already in place may present requirements for introducing changes in the document's instruction, ND, General characteristics of the medicine, package design, etc. It is not necessary to overestimate the relationship between the benefits of using the drug and the health risk.

 

The order for passing the procedure in countries where the medicine was not registered before

 

Medicines can be registered in the EEU countries under the procedure of mutual recognition (if they were not previously registered), if the dossier meets the requirements of the union in the reference country.

 

To perform the procedure, the following documents must be submitted:

  • Application.
  • Receipts for payment of the state duty for the matching procedure.
  • Registration dossier for the drug

 

In the requirements for registration of the dossier there are nuances. In accordance with the requirements of the EEU, modules 1-5 must be brought. The last, the sixth module - "Clinical tests" may not be brought into line. But only in the event that the dossier was drawn up before the entry into force of the agreement.

 

In the framework of the described procedure, a mandatory reassessment of the ratio of benefit and risk in accordance with the rules for the registration of medicines in the manner of mutual recognition.

 

 

Assistance in harmonization

Experts of the Center for Clinical Research "Promedika" can provide the necessary consulting services within the procedure of bringing the drug dossier into compliance with the requirements of the EEU. You can get advice on this issue and order the service by phone or by using the feedback 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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