• Evaluation of medicinal products in the reference state and in the member state concerned: what’s the specifics in each case?
• What deadlines are legally set for the medicinal product evaluation within the mutual recognition procedure?
• How does the medicinal product approval occur within the mutual recognition procedure?

Answer by our legal counsel

Applicant’s Rights Related to Marketing Authorization of Medicinal Products in the EAEU

According to paragraphs 20-25 of the EAEU Rules for Marketing Authorization and Expert Assessment of Medicinal Products for Human Use (hereinafter referred to as the Rules) approved by the Decision of the Council of the Eurasian Economic Commission No 78 of November 03, 2016 (hereinafter referred to as Decision No 78), marketing authorization of medicinal products in the EAEU member states is performed at the request of the applicant as follows:

a) Synchronously in several member states according to the decentralized procedure.

A decentralized procedure is used synchronously by several member states receiving an application for marketing authorization of a medicinal drug, with a reference state specified.

b) Sequentially in several member states according to the mutual recognition procedure.

The mutual recognition procedure is performed as follows:

1. By the reference state for the medicinal products intended for marketing in that state only (national marketing authorization procedure);
2. In the member states concerned at the applicant’s discretion after approval of the medicinal product in the reference state within the mutual recognition procedure.

A simultaneous initiation of the mutual recognition procedure at more than one member state concerned is allowed.

The Applicant has a right to:

1. Choose the reference state and the member state concerned as needed when submitting an application.
   Only one state can serve as a reference state.
2. Recall its application at any time prior to completion of the authorization procedure, by sending a written notification to the authorized body of the member state reviewing the application.
   If the application is recalled, the authorized body of the member state reviewing the application, discontinues its review and returns originals of documents and/or information accompanying the application.

Marketing Authorization and Evaluation of Medicinal Products Within the Mutual Recognition Procedure

The procedure will differ for the reference state and the member state concerned.

The marketing authorization and evaluation of a medicinal prouct in the reference state is regulated by paragraphs 46-65 of the Rules.

For the purpose of marketing authorization the applicant shall submit the following documents and materials to the authorized body (expert panel) of the reference state:

• An application either on paper and/or as an electronic document in the prescribed form according to Appendix No 2 to the Rules, signed with an electronic digital signature;
• Documents supporting payment of duty (fee) for marketing authorization and evaluation of the medicinal product as and where stipulated by the legislation of the reference state, either on paper or as an electronic document signed with an electronic signature;
• Registration dossier in an electronic format, as a kit of electronic documents;
• Samples of medicinal products;
• Standard samples of active pharmaceutical substances and reagents required for medicinal product testing as agreed with the expert panel;

The evaluation of the medicinal product in the reference state includes:

1. Assessment of the scope, fullness and accuracy of preparation of the documents included into the registration dossier;
2. Safety, efficacy and quality evaluation of the documents and information provided by the applicant in the registration dossier for the medicinal product;
3. Laboratory tests for compliance with the requirements of the normative document on quality and reproducibility of the claimed quality control methods used by accredited testing laboratories;
4. Initiation, as needed, of a pharmaceutical inspection in certain cases;
5. Preparation of an expert evaluation report for the medicinal product.

Time required for evaluation and responding to queries

According to paragraph 46 of the Rules the period for marketing authorization and evaluation of the medicinal product in the reference state should not exceed 140 days from the date of submission of the application to the date of granting the marketing authorization (MA).

According to paragraphs 53-55 of the Rules the evaluation process can be suspended for ≥90 business days to allow the applicant to provide any missing materials and give clarifications, with a possibility for additional extension for 90 business days where reasonably required, so that the overall period granted for responding to inquiries should not exceed 180 business days.

Marketing authorization of a medicinal product in the reference state can be refused in the following cases (paragraph 64 of the Rules):

1. The expected benefit to possible risk ratio of using the medicinal product is not favorable;
2. The effectiveness of the medicinal product is not supported by the data provided by the applicant;
3. The quality of the medicinal product is not supported;
4. The quality control methods and procedures are not reproducible;
5. The applicant provided unreliable data;
6. Compliance with Good Pharmacy Practice (GxP) in EAEU is not supported based on the inspection performed in the process of marketing authorization of the medicinal product.

Marketing authorization and evaluation of the medicinal product based on a mutual recognition procedure in the member state(s) (MS) concerned is regulated by paragraphs 66-82 of the Rules.

After marketing authorization of the medicinal product in the reference state the applicant can initiate marketing authorization in other member-states (MS) within the mutual recognition procedure to the authorized bodies (expert panels) of such member states.

Required documents:

• Marketing authorization application within the mutual recognition procedure in paper format and/or as an electronic document bearing an electronic signature;
• Documents supporting payment of duty (fee) for marketing authorization and evaluation of the medicinal product as and where stipulated by the legislation of the member state concerned, either on paper or as an electronic document;
• Module 1 of the registration dossier on electronic media or in an electronic form;
• SmPC, package leaflet and drafts of packaging in the official language of the MS if required by the legislation of the member state.

Access to the registration dossier of the medicinal product and expert evaluation report for the authorized bodies (expert panels) of the member-states is provided at the applicant’s request by the authorized body (expert panel) of the reference state.

Period of Marketing Authorization of the Medicinal Product in the Member State Concerned

Marketing authorization is granted for the medicinal product in the member state concerned in the absence of disagreement between the authorized bodies of that member state and the reference state and if there is a conclusion on approval of the expert evaluation report, not later than 60 business days from the date the expert panel is granted access to all versions (sequences) of the electronic registration dossier used for preparation of the expert evaluation report, and to the approved expert evaluation report.

Expert evaluation of the medicinal product within the mutual recognition procedure in the member states is performed within 40 business days from the date of providing access to the expert evaluation report as follows:

а) review of the application, document and information provided in the registration dossier, effective (as amended, if relevant) in the reference state as on the date of submission of the application in the member states;

b) review of the expert evaluation report prepared by the expert panel of the reference state, effective in the reference state as on the date of submission of the application in the member states.

If required, in the process of marketing authorization of the medicinal product within the mutual recognition procedure the authorized body (expert panel) of the member state concerned shall submit an inquiry to the applicant and to the authorized body (expert panel) of the reference state within 30 business days from the date of gaining access to the expert evaluation report.

The applicant shall provide a response to the request within the term not exceeding 90 business days. If the applicant fails to provide the document and information requested by the authorized body (expert panel) of the member state concerned within the specified deadlines, the evaluation and marketing authorization of the medicinal product in that member state will be suspended.

The authorized body (expert panel) of the member state concerned, based on the medicinal product evaluation results, within 5 business days from the date of evaluation completion, as specified in paragraph 69 of the Rules, using an integrated system, shall submit a report stating whether or not the expert evaluation report submitted by the reference state can be accepted. The authorized body of the reference state shall notify the applicant on the decision made using telecommunication media and shall make a decision on whether or not the expert evaluation report submitted by the reference state can be accepted.

If the authorized body of the member state issues a positive opinion on the marketing authorization of the medicinal product based on its evaluation results, the authorized body of the member state concerned within 5 working days shall:

а) issue a marketing authorization certificate to the applicant according to the form provided in Appendix No 17 to the present Rules, as well as approved SmPCs, package insert, drafts of packaging in the official language of the member state concerned, if required by the member state;

b) review a normative document on quality issued by the reference state;

c) publish the information on the medicinal product and active substances in a unified register, appending the approved SmPC, package insert, drafts of packaging, a coordinated risk management plan (if required) according to the procedure of preparation and maintaining the unified register.

The marketing authorization certificate for the medicinal product is issued by the authorized body of the member state for a period established by the reference state.

Marketing authorization of a medicinal product, approved according to the present Rules in other member states, which had not been specified in the primary marketing authorization application as member states, or in the states joining the Union after the approval of the medicinal product, will be performed within the framework of the mutual recognition procedure based on review of the effective version of the expert evaluation report prepared by the expert panel of the reference state.

December 09, 2022