News and Educations

Marketing authorisation procedure in the Republic of Kosovo accelerated for medicines authorised by HALMED


The Kosovo Medicines and Medical Devices Agency (AKPPM) has notified HALMED on the provisional change of Ordinance on granting marketing authorisation. This change will facilitate and accelerate authorisation of all medicines authorised by HALMED and thus pave the way for easier placing of products of Croatian manufacturers to the Kosovo market.

Under provision of this Ordinance, for medicinal products authorised by HALMED, applicants are required to submit only CTD Module 1 and the marketing authorisation procedure will last up to 70 days.

This regulatory change is a result of a successful cooperation between HALMED and AKPPM, based on which HALMED is recognised as a reliable and responsible partner in the regional regulatory environment that ensures efficacious, quality and safe medicines top all patients and users.