Visit of HALMED delegation to the Kosovo Medicines Agency (AKPPM)
11.12.2014
Upon invitation by the Kosovo Head of Agency, Mr Arianit Jakupi, a delegation of the Agency for Medicinal Products and Medical Devices (HALMED) led by the Head of Agency, Dr Viola Macolić Šarinić, MD, PhD, visited from 8 to 9 December 2014 the Kosovo Medicines Agency (AKPPM). HALMED and the AKPPM concluded a mutual collaboration agreement in 2013 in the field of the OMCL and regulatory affairs regarding medicines authorisation and pharmacovigilance. Mr Jakupi delivered an honorification to the Head of HALMED for her efforts in fostering the bilateral cooperation between these two competent authorities. The experts from the Kosovo quality control laboratory were at the study visit to the HALMED’s OMCL in 2013 and 2014. During the visit an additional education for the Kosovo experts by HALMED experts was agreed through the EU’s TAIEX project in the field of medicines regulation and other practical aspects of medicines authorisation and pharmacovigilance.
The Croatian delegation was also received on 9 December 2014 by the Kosovo Minister of Health, Professor Ferid Agani for a brief discussion confirming that the Kosovo Medicines Agency would recognise all marketing authorisations issued by HALMED without repeating the assessment and thus speeding up and facilitating the granting of marketing authorisations for medicinal products of Croatian manufacturers in Kosovo. This provision is set out in the new ordinance on granting a marketing authorisation that is pending and is under the responsibility of the Kosovo Ministry of Health. This agreement paves the way for Croatian pharmaceutical manufacturers to place their medicinal products on the Kosovo market, as HALMED is being recognised as a safe and responsible partner in the regulatory environment of the region, ensuring efficacious, quality and safe medicines to all patients and users.
