The Libyan Health Law act number 106 of 1973 and its explanatory notes of 1975 state that registration of medicines within the Libyan Ministry of Health should precede the availability of any medicine in the Libyan market. However, there is a lack of an active registration process and this has created a negative impact on the quality of medicines in Libya.
Medicine registration is inactive and is mainly hindered by a lack of independence, minimal infrastructure, and the lack of appropriately trained personnel. The WHO has stated that medicines registration in Libya not only lacks the availability of a defined independent body, but also operates with a limited technical capacity and infrastructure that is not sufficient for the optimal approval of the quality, safety, and efficacy of medicines in the Libyan healthcare system.
The WHO also stated that appropriately equipped government quality assurance laboratories are lacking, and quality assurance is mainly undertaken in some schools of pharmacy with limited expertise and operating facilities.