The NA Standing Committee on Health Care organized a work discussion on the state registration process of medicines, the existing problems and mechanisms aimed at solving them.
The Committee Chair Arsen Torosyan emphasized the importance of such discussions from the viewpoint of voicing the problems of the sector and proposing the necessary toolkits for their regulation.
The President of the Independent Pharmacies Association Artur Khachatryan touched upon two sectoral issues: The availability of medicines in the Republic of Armenia and the process of checking the quality and safety of them.
Presenting a number of statistical data and studies, Artur Khachatryan opined that if the issue of legal availability of medicines in Armenia is not resolved, the circulation of medicines through smuggling and unregistered means will continue.
The rapporteur also spoke about the regulations of the legislative field. In his opinion, it is necessary to study the list of the EEU Unified Register, and since these medicines are registered in the same regulatory procedure as in the Republic of Armenia, the medicines that are necessary for the population of the Republic of Armenia should also be recognized in the EEU Unified Register. According to Artur Khachatryan, laboratory examination of medicine quality in Armenia should be made mandatory, taking into consideration the previous legal experience.
The RA Minister of Health Anahit Avanesyan assured that the issues regarding the medicine market and medication safety are in the focus of their attention.
The Minister detailed the medicine registration procedures, noting that Armenia, being a member state of the EEU, is constrained by the relevant legislation and is obliged to follow the EEU regulations. According to the Minister responsible for the sector, our country cannot have regulations different from the EEU. For this, the path of expanding the possibilities for importing unregistered medicines has been chosen.
Anahit Avanesyan informed that amendments are planned to the Law on Medicine, adopted back in 2016. All the concerned parties will be invited to the discussions.
During the Q&A session and speeches, the procedures for importing unregistered medicines, the possibility of extending the national registration mechanisms, the effectiveness of state procurement in the drug market, the conditions for importing a certain amount of medicines for personal needs, and legislative a number of issues requiring resolution.
According to the agreement reached, the participants in the discussion will soon submit written proposals that can serve as the basis for the necessary legislative amendments.
The representatives from the Government, pharmacy and medical associations, medical centers, pharmacies and pharmaceutical companies participated in the discussion of March 24.
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