AmCham Healthcare Committee Reviewing Two Important Regulations

AmCham Healthcare Committee Reviewing Two Important Regulations

• 19.06.2015

AmCham Healthcare Committee members have commented this week on two important draft Regulations:
Regulation improving the existing mechanism of medicines selection for compensation from the funds of National Company for Health Insurance. The existing Regulation is a deficient one, stipulating no clear eligibility criteria for medicines to be included in the list. Also, it doesn\'t specify the procedure to be followed by companies in order to present their products for compensation. AmCham members brought several ideas clarifying the deficient aspects.

Regulation on medicines authorization/re-authorization. At the beginning of this year, the National Agency of Medicines and Medical Devices changed the rules of medicines packaging authorization, to enter into force as of November 2015. Producers have not been duly consulted on the new regulations, so, the amendments bring radical changes in medicines packages authorization, practically, making it impossible for many important drugs to be registered and placed on Moldovan market. Committee will work further to improve it.

Mila Malairau, Committee Coordinator, has also participated in the launching of the new business association of pharmaceutical producers. AmCham was asked to become partner of the Association an contribute with joined efforts to the improvement of healthcare system in Moldova.