Transition period for registration of medicinal products in EAEU
As it is known, many pharmaceutical companies are gradually moving to the EAEU market at present. The reason for this tendency is the “Agreements on Common Principles and Rules for the Circulation of Medicinal Products in the Framework of the Eurasian Economic Union” dated December 23, 2014, Decision of the Supreme Eurasian Economic Council No.108 dated December 23, 2014 “On the Implementation of the Agreement on Common Principles and Rules for the Circulation of Medicinal Products in the Framework of the Eurasian Economic Union” and the Decision of the Eurasian Economic Commission Council No 78 dated November 03, 2016. “On the Rules for Registration and Expertise of Medicinal products” (hereinafter - Decision No.78).
According to Decision No. 78, the pharmaceutical companies may conduct registration according to their national procedure until December 31, 2020. Anymedicinal products registered according to the national procedure acting till December 31, 2020 shallget harmonized with the EAEU requirements by December 31, 2025 (Decision No.78, Clause 170). The duration of the harmonization with the EAEU requirements shall take 100 calendar days.
There are General principles of registration and specific requirements to the documents of a registration dossier for a medicinal product within the EAEU.
Manufacturing of medicinal products shall comply with the Rules of the Good Manufacturing Practice of the Eurasian Economic Union (hereinafter referred to as the Union) (Decision No.78, Clause 28).
At the time of submitting an application for registration, re-registration, harmonizationof medicinal product with the technical requirements of the Union, the manufacturer shall submit a valid document in the marketing authorization application dossier confirming compliance with the requirements of the Good Manufacturing Practice (GMP) of the Union of the manufacturing site (facilities) where the finished product applied for the marketing authorization, confirmation (renewal) of the marketing authorization or bringing into compliance with the requirements of the Union is manufactured and is tested .
Up until December 31, 2020, in the absence of the document confirming compliance with the Union GMP requirements, the manufacturer shall be entitled to submit the document confirming compliance of the manufacturing site (facilities) with the GMP requirements, issued to the manufacturer of the medicinal product by the authorized body of the manufacturing country (Decision No78, Clause 29).
Pre-clinical safety studies of medicinal products manufactured in the countries which are not Member-states of the Union shall be taken into account within the expertise of the medicinal product on the condition that they have been designed, implemented, and reported in accordance with the requirements of the Good Laboratory Practice that are equivalent (or not inferior) to the provisions of the Union.
Clinical studies of medicinal products manufactured in the countries which are not the Members-states of the Union shall be taken into account within the expertise of the medicinal product if they have been designed, implemented, and reported in accordance with the requirements of the Good Clinical Practice that are equivalent (or not inferior) to the provisions of the Union and the principles of the Helsinki World Medical Association Declaration –“Ethical Principles for Medical Research Involving Human as Trial Subjects” (Decision No78, Clause 5)
Within the medicinal product registration procedure, the clinical study reports included in Module 5 of its registration dossier shall be taken into account in the expertise subject to either of the following conditions:
- the clinical studies had been conducted in compliance with the Member-states legislation and within their territory before 1 January 2016 (based on the date of the last visit of the last patient (volunteer)) or were being conducted as of 1 January 2016 (when the recruitment of the patients (volunteers) into those studies have been completed);
- the clinical trials had been conducted partially or fully within the countries of the International Conference for Harmonization of Technical Requirements for registration of medicinal product (ICH) for human use before 1 January 2016 (based on the date of the last visit of the last patient (volunteer)), based on which the medicinal product has been authorized for marketing in the countries of the International Conference for Harmonization of Technical Requirements for registration of medicinal products (ICH) for human use;
- clinical trials commenced after 1 January 2016, have been conducted in compliance with the international agreements and acts, which constitute the law of the Union, given that at least one clinical study has been conducted fully or partially (as regards of the data obtained from the trial subjects) within the Union.
If the requirements are not complied with, before applying for the marketing authorization for a medicinal product, the manufacturer shall conduct clinical trials (at least one trial at the manufacturer’s disposal and competent authority agreement) fully or partially within the Union, or, within the expertise of the registration dossier, the competent authority shall trigger an unscheduled inspection of one of the clinical trial sites where the trials have been conducted,.
It is important to note the format for submitting a registration dossier. According to the Decision of the Eurasian Economic Commission Council No.79 dated June 30, 2017 “On the Requirements to the Electronic Form of Applications and Documents of the Registration Dossier Submitted when Registering and Examining Medicinal Products for Human Use”, the registration dossier shall be provided in XML (eXtensible Markup Language) format.