The Eurasian Economic Union (EAEU) is a common economic area among Russia, Belarus, Kazakhstan, Armenia, and Kyrgyzstan. As part of efforts to simplify cooperation and increase trade volume among the countries, uniform procedures have been developed in many economic sectors.
In particular, the decisions of the Permanent Council of the Eurasian Economic Commission N78 and N88 from November 3, 2016, were adopted, stating that starting in 2021, all EAEU member countries are required to conduct the registration of pharmaceuticals according to uniform rules.
After registration, these will be included in the Unified Register of Medical Products. Compliance with uniform rules increases the availability of pharmaceuticals in these EAEU countries and thus improves the quality of life for the populations of the EAEU states.
EAC Registration of Pharmaceuticals
To register a pharmaceutical according to the rules of the EAEU states and to record it in the official register, the manufacturer must go through all registration stages.
The registration can be conducted either sequentially in several countries (mutual recognition procedure) or simultaneously in several countries (decentralized procedure). The applicant independently selects the reference country and the registration procedure.
Registration through the mutual recognition procedure:
Initially, the pharmaceutical is registered in the reference country (registration is only possible in this country), and only thereafter can the pharmaceutical be registered in other countries through the mutual recognition procedure.
Registration through the decentralized procedure:
The pharmaceutical is registered simultaneously in several countries with the selection of a reference country.
The Phases of Registration:
- Analysis of registration documents
- Development of a strategy for pharmaceutical registration
- Conducting necessary preclinical studies
- Compilation of the document package for clinical trials
- Obtaining approval for clinical trials
- Preparation of the clinical trial report
- Drafting of registration documents
- Conducting assessments of samples
- Supporting the registration process
- Responding to expert inquiries
- Receiving the registration certificate
- Pharmaceutical registration
Upon completion of the procedure, the manufacturer receives a registration certificate for the pharmaceutical in the EAEU states, which is valid in all or registered countries of the EAEU states.
For the initial registration, the certificate is issued for 5 years. For subsequent extensions of registration, an unlimited registration certificate is issued.
Deadlines for EAC Registration of Pharmaceuticals
1. Preparation and submission of registration documents – from 30 calendar days.
2. Preparation of responses to inquiries from the Ministry of Health – from 14 calendar days.
3. Registration and examination of the pharmaceutical under the decentralized procedure – 210 calendar days.
4. Registration and examination of the pharmaceutical under the mutual recognition procedure – 210 calendar days.
5. Registration in the recognizing country – 100 calendar days from the day of application for pharmaceutical registration to the day of publication of information in the unified register of the union and issuance of the registration certificate.
6. Re-registration of the pharmaceutical – 120 calendar days from the day of application for re-registration. Excluding downtime: the time from the request for additional materials and data to the response to the request.
Fee Rates for EAC Registration of Pharmaceuticals
The fee rates for state registration of pharmaceuticals:
1. For conducting the examination of a pharmaceutical for medical use upon its initial registration – 4,995.00 Euros.
2. For conducting the examination of a pharmaceutical with well-researched medical use upon its initial registration – 4,750.00 Euros.
3. For confirming the registration of a pharmaceutical for medical use – 4,250.00 Euros.
4. For issuing the registration certificate of a pharmaceutical for medical use – 495 Euros.
The company AC Inorms GmbH offers a comprehensive service for the preparation and submission of EAC registration documents, including document preparation and responding to inquiries from experts of the relevant authorities.
Our Services
We offer our clients the following services:
- Analysis of product documentation
- Development of a draft of the package leaflet
- Development of a draft of the product characteristics of the pharmaceutical
- Preparation, organization, and conduct of the pharmaceutical report
- Recommendations for assessing the completeness of registration documents
- Preparation of the application for state EAC registration of the pharmaceutical
- Preparation of the electronic version and formatting of the documents
- Validation of registration documents in the applicant portal
- Submission of the document set to the Ministry of Health
- Responding to inquiries from the competent authority
- Consultation in document preparation
- Monitoring of the pharmaceutical examination
- Receiving the approved document set
- Initiating the pharmaceutical examination
- Submission of responses to inquiries
For EAC registration and EAC certification of pharmaceuticals in the EAEU states in Russia, Belarus, and Kazakhstan, please contact us; we are happy to assist you by phone and in person.
