The Macedonian Assembly has adopted extensive amendments to the Law on Medicinal Products and Medical Devices (“Law on Medicinal Products”) that came into force on 01 February 2012. The Macedonian Ministry of Health stated that these amendments harmonise national legislation with European Commission recommendations, improve and accelerate the procedures and deadlines and prescribe stricter misdemeanor and penalty provisions. One of the most important novelties is the introduction of parallel import of medicines. By allowing this, competition in pharmaceuticals will increase and the price of medicines should decrease.
If a wholesaler or producer decides to withdraw a certain medicinal product off the market they must allow for two months supplies and report the planned removal of production/import of the particular medicines eight months in advance. The pecuniary penalties are up to EUR 100,000, and moreover, authorized persons of such producers/wholesalers failing to comply could face imprisonment.
The Agency for Medicinal Products shall be established by 2014. In the meantime, the Bureau for Medicinal Products shall continue to be the administrative state body regulating the Law of Medicinal Products.