The proposed amendments are divided into several groups. The first group is the harmonization with the EEU regulations, certain clarifications and adjustments of notions: The RA Minister of Health Anahit Avanesyan said during the debate of the legislative package providing for addenda and amendments in the package of draft laws on Medicine and the related laws. The issue was debated in the first reading at the sitting of the NA Standing Committee on Health Care on January 31.
According to Anahit Avanesyan, it was established that within the framework of the function of registration of drugs by the state, the appropriate organization appointed by the Government carries out the examinations. She informed that reorganization of scientific center of drug and medical technology expertise CJSC to SNCO is being carried out.
Narek Zeynalyan inquired how the activity of the scientific center of drug and medical technology expertise will proceed during the reformulation period from CJSC to SNCO.
“We have done everything to complete all the unfinished things. Any reformulation is a difficult process, and we will do everything for the benefit of importers and producers so that problems do not arise,” the representative of the Government said.
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The Chair of the Committee Narek Zeynalyan presented proposals regarding the legislative package. Referring to the issue of non-compliance with the registration form and relabeling of the imported medicine, he proposed to reformulate the relevant provision so that the function of sealing the packaging with a cover sheet and matching the records with the registration form should also be carried out through an entity with a medicine production license. The Chair of the Committee also proposed to establish a list of unregistered medicine due to the given emergency situation, within the framework of which it will be allowed to import unregistered medicine. The proposals were accepted.
The Committee endorsed the legislative initiative.
The Committee debated and approved the draft on defining the 2024 annual schedule for the organization of reception of the citizens in the RA NA Standing Committee on Health Care.
National Assembly of the Republic of Armenia
