Traditionally, at the end of the year we recollect all the important events and sum up the result of the year gone by.
International cooperation is an integral area of concern of our enterprise. In April a Memorandum of Understanding and Cooperation was signed between the Centre for Examination and Tests in Health Service UE and the State Institute for Drug Control (Slovakia) within the framework of a Belarusian-Slovak business forum. In November, a group of delegates of the Ministry of Health of the Slovak Republic paid a return visit to the Republic of Belarus. A visit programme included attendance of a range of health care facilities including the Centre for Examination and Tests in Health Service UE. A meeting took place in the Laboratory of Pharmacopoeial and Pharmaceutical Analysis. Slovak colleagues recognised a high level of technical capacity, a wide range of tests conducted, and highly appraised laboratory activities. In September, a Memorandum of Cooperation in the area of medicinal products and medical devices circulation was signed by Food and Drug Administration of the Islamic Republic of Iran; in October, in Kishinev a Memorandum of Understanding and Cooperation was signed by Medicines and Medical Devices Agency of the Republic of Moldova.
Enterprise specialists took an active part in implementation of the European Union international technical assistance project called “International Accreditation of Testing Laboratories for Medicinal Products in Belarus” (ITA project BELMED). Within the framework of this project assistance in comprehensive preparation for compliance of the national (state) medicinal products quality control system with international standards to receive international recognition of Official Medicines Control Laboratories (OMCL) of the European Directorate for the Quality of Medicines (EDQM) was provided. An important objective of the project is to provide assistance in the integration of the control system of medicinal products circulation in the Republic of Belarus to the European system. Project experts assist in increasing capacities of specialist and preparation for integration of the Pharmaceutical Inspectorate of the Ministry of Health of the Republic of Belarus into the Pharmaceutical Inspection Co-operation Programme (PIC/S). Achievement of this objective will contribute to the international recognition of national certificates compliant with GMP requirements and an increase in the export potential of Belarusian manufacturers of medicinal products with guaranteed quality, efficacy and safety.
Specialists of the Department of Good Pharmaceutical Practices have developed a new version of Technical Code of Common Practice 030-2017 “Good Manufacturing Practice” (approved by the Decree No. 64 of the Ministry of Health of the Republic of Belarus dated 19.06.2017).
The Pharmaceutical Inspectorate of the Ministry of Health of the Republic of Belarus which includes the Department of Good Pharmaceutical Practices was established by the Order No. 1193 of the Ministry of Health of the Republic of Belarus dated 16.10.2017. Department specialists were included in the Registry of Pharmaceutical Inspectors of the Republic of Belarus and were authorised to carry out inspections of industrial manufacturing of medicinal products on compliance with the GMP requirements.
The State Centre for Accreditation of the Republic of Belarus confirmed the competence of the Laboratory of Pharmacopoeial and Pharmaceutical Analysis, as well as Medica product certification body.
A number of regulatory legal acts came into force on May 6, 2017 according to which applicants can submit documents for registration of medicinal products and medical devices under unified rules of EAEU for the purpose of including them in the Eurasian Economic Union unified registry of registered medicinal products and the unified registry of medical devices registered in the Eurasian Economic Union. The Resolution No.78 of the Council of the Eurasian Economic Commission On Rules for Registration and Expertise of medicinal products for medical use dated 03.11.2016, and the Resolution No.46 of the Council of the Eurasian Economic Commission On Rules for Registration and Expertise of safety, quality and efficacy of medical devices dated 12.02.2016 were adopted among others.
It was an anniversary year for our enterprise. We achieved a lot during this period. Modern material and technical resources, high qualification and hard-working nature of our specialists allow us to achieve great results and develop.
Dear friends, colleagues, readers, and authors, we wholeheartedly congratulate you on New Year and Christmas! May 2018 be lucky and fruitful, filled with new ideas, vivid events, good news and financial success. May happiness, prosperity and emotional warmth not leave your home and families!