In a significant move to overhaul the medical sector's regulatory framework, Armenia's Health Minister Anahit Avanesyan presented proposed amendments and additions to the country's 'On Medicine' law. The presentation, which took place in Yerevan on February 27, underscores a concerted effort to address critical issues related to medicine registration, clinical experiments, and the harmonization of import regulations that have emerged since the law's inception in 2016.
During the session, Minister Avanesyan outlined the primary challenges that have hindered the effective regulation of the medical sector. Among these, the ambiguity surrounding the organizations responsible for conducting examinations and professional observations stands out, leading to inefficiencies within the Armenian Health and Labor Inspection Body. The minister's critique extended to the current legislation's inability to provide clear definitions and authorizing norms, which are crucial for amending government decisions on matters such as parallel import permissions and import certification processes.
Feedback from importing companies played a pivotal role in shaping the legislative package, highlighting the necessity for reforms in the refusal system of permission for parallel imports. The proposed amendments aim not only to clarify the link to import certification processes but also to address broader aspects of the medical sector, including the regulation of clinical experiments, infrastructure for pathological anatomical dissections, import facilitation, and pricing policy. The comprehensive nature of the discussion, which also garnered the endorsement of the NA Standing Committee, reflects a broad consensus on the need for legislative improvements.
The proposed legislative package represents a critical step towards aligning Armenia's medical sector with international standards, ensuring a more effective and transparent regulatory environment. By addressing the identified shortcomings, the amendments hold the promise of significantly improving the medicine registration process, streamlining clinical experiments, and facilitating smoother import procedures. As these changes are debated and potentially implemented, the focus will undoubtedly remain on their impact on both the healthcare system and the broader public health landscape in Armenia.
For more information on the proposed amendments and the session in Yerevan, visit Armenpress and the National Assembly of the Republic of Armenia.
https://bnnbreaking.com/politics/armenia-proposes-key-amendments-to-medicine-law-aiming-for-enhanced-regulation-and-import-processes