The addenda and amendments being proposed to the law on Medicine and the enclosed laws will promote the processes of medicine registration, the regulation of the clinic experiment sphere, and the medicine import will be harmonized.
At the NA sitting the RA Minister of Health Anahit Avanesyan informed and added that during the implementation of the implementation of the law on Medicine adopted in 2016 a number of shortcomings were revealed, which impede the full regulation of the sphere. Certain problems were also recorded in the legal practice of the RA Health and Labor Inspection Body, including the implementation of the examinations.
By the Minister’s observation, the law does not envisage definition of the organization implementing examinations and professional observations in the state regulation of circulation of medicine. Authorizing norms are necessary for changing the decisions of the Government.
According to Anahit Avanesyan, one of the shortcomings is that refusal system of permission of parallel import and its providing is designed, without specifying the connection with the import certification processes and the refusal bases. It was noted that while making up the package the proposals of the importing companies was taken into consideration.
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During the Q&A session the Minister touched upon the implementation of the clinical experiments and the control towards them, the deployment of the infrastructures designed for the pathological anatomical dissections in the Medical Centre envisaged in Vardenis, the facilitation of the import of the medicine in legal way, the pricing policy in the medicine market and other issues.
Hrachya Hakobyan informed about the endorsement of the NA Standing Committee on Health Care.
National Assembly of the Republic of Armenia
