For the purpose of creation of conditions for forming the common market of drug products and implementation of the Agreement on unified principles and rules of circulation of drug products within the Eurasian Economic Union (hereinafter referred to as the Union), Resolutions of the Council of the Eurasian Economic Commission (EEC) dated November 3, 2016 approved a number of documents establishing the requirements for assuring all aspects of safety, effectiveness and quality of drug products. Some of these refer to the issues of arrangement and inspection of pharmaceutical productions:
- Rules of Good Manufacturing Practice of the Eurasian Economic Commission;
- Rules of Good Distribution Practice of the Eurasian Economic Commission;
- General requirements for the quality system of pharmaceutical inspectorates of the member-states of the Eurasian Economic Commission;
- Rules of performance of pharmaceutical inspections;
- Procedure of forming and keeping the Register of pharmaceutical inspectors of the Eurasian Economic Commission;
- Procedure of assuring joint pharmaceutical inspections.
Acceptance of these documents and their implementation in the national system of drug product circulation regulation will involve significant efforts from the authorised bodies and concerned organisations of the Union’s member states including their close interaction. Thus, for the purposes of development of international cooperation of the Russian Federation and the Republic of Belarus in the sphere of using the international standards of regulating production of drug products in December 2016, our country was visited by Vladislav Nikolayevich Shestakov, Director of State Institution of Drug Products and Good Practices Federal Budget Institution, Deputy Head of the Pharmaceutical Inspectorate, with colleagues from the Ministry of Industry and Trade of the Russian Federation. During the visit, a number of working meetings was held and the agreement on cooperation between State Institution of Drug Products and Good Practices FBI (Russian Federation) and the Centre of Examination and Testing in Health Service UE (Republic of Belarus) was signed. Being guided by the norms used by states in the sphere of drug product circulation harmonisation to improve population provision with quality, effective and safe drug products, the parties agreed to interact and cooperate in such business directions as coordination of positions at international forums on drug product circulation, information sharing and provision of mutual support in the sphere of adoption of the international requirements for production of drug products including the rules of Good Manufacturing Practice (GMP), scientific and educational activities, joint meetings, conferences, seminars, staff training and upgrading for inspecting production of drug products for compliance with the GMP requirements. This agreement will enable more productive interactions in the sphere of harmonisation of approaches to inspecting pharmaceutical production areas in the territories of our countries and implementation of educational projects including educational and joint inspections.
At present, the Republic of Belarus has started work concerning implementation of decisions taken by the Council of the EEC. The national rules of Good Manufacturing Practice and the rules of Good Practice of Drug Product Wholesale are under revision to bring in line with the documents of the Eurasian Economic Commission.
The Council of the Eurasian Economic Commission adopted Decision dd. 03.11.2016 No. 93 “On recognition of drug product manufacture inspection outcomes” according to which prior to December 31, 2020 the authorised bodies of the Union’s member states, when performing state registration (registration confirmation, making amendments to the Master File) of drug products according to the legislation of the Union’s member state mutually recognise the documents issued by the authorised bodies of the Union’s member states which confirm compliance of drug product manufactured in the Union’s member states with the Union’s GMP requirements or those of the Union’s member states.
According to the Decision of the Commission for Drug Products of the Ministry of Health of the Republic of Belarus (minutes dated 13.01.2017 No. 1), in case of document presentation for state registration (registration confirmation, making amendments to the Master File) of drug products after Decision of the Council of the EEC dated 03.11.2016 No. 93 (since 01.12.2016) has entered into force enclosing the copies of the existing document issued by the authorised body of the Russian Federation (the Ministry of Industry and Trade of the Russian Federation) confirming compliance of drug product manufactured in the Russian Federation with the requirements of Good Manufacturing Practice, such document will be recognised and inspection of drug product manufacture will not be scheduled. Recognition will cover those stages of drug product manufacture only which will be covered by the document presented. As to productions (individual production stages) in relation to which the document has not been presented or do not cover, inspection will be scheduled.