New structure of the Agency

07.04.2010

At the meeting held on 24 March 2010, the Government of the Republic of Croatia gave its consent for the new Statute of the Agency for Medicinal Products and Medical Devices, whose adoption was necessary in order to harmonise the activity of the Agency with the current Medicinal Products Act and the Medical Devices Act.
The Statute provided for the new organisation of the Agency which will better support the Agency's public health function.

In addition to the Directorate, the Agency will have four departments:

Official Medicines Control Laboratory Division, responsible for the laboratory control of the quality of imported and locally manufactured medicinal products and vaccines, most often sampled at the market, at the level of pharmacies and wholesalers.
Marketing Authorisations Division is where all pre-registration procedures for the medicines of local manufacturers, medicines authorised for marketing in the EU under the nCADREAC (New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern Europe) and the medicines from third countries, take place. Within the Division, there is a Department which, based on the medicinal product documentation, evaluates its quality, safety and efficacy, and the Committee for Medicinal Products composed mainly of independent external experts. Additionally, the Division monitors variations in the marketing authorisation documentation and information relating to medicinal products throughout the five-year period of validity of the marketing authorisation as well as renewals thereof after the expiry of the five-year period.
Division for Safe Use of Medicinal Products and Medical Devices is focused on the patient as the end user of medicinal products, as well as on healthcare professionals. This Division monitors all adverse reactions to medicines and vaccines in the Croatian market and clinical trials, and promotes rational pharmacotherapy. In addition to healthcare professionals, ADRs may now be reported to the Agency directly by the patients. Furthermore, the Division is involved in preparation of various public notices, and it also monitors medicine consumption, medical device registration process and vigilance thereof, verifies the compliance of the local manufacturers with the good manufacturing practice, issues various licenses (import/export, wholesale, retail sale in specialised shops) and finally, if necessary, recalls medicinal products and medical devices from the market.
The Agency also has a Division for Legal, Economic, IT and General Affairs, and there is also the Central Ethics Committee, working within the Agency, issuing ethical and expert evaluations for clinical trials in Croatia.

The Agency is now into the 7th year of its existence, with 125 employees. The official abbreviation of the Agency's name is HALMED (hrvatska Agencija za lijekove i medicinske proizvode).

As medicines are one of the best regulated areas of acquis communautaire, the Agency is very active in international collaboration so as to prepare itself for the work in an integrated regulatory area, once Croatia becomes a Member State. Within the Instrument of Pre-Accession (IPA), the Agency's experts participate as observers in certain committees and working groups of the European Medicines Agency (EMA). In May 2010 in Split, the Agency will host the 15th Annual Meeting of Official Medicines Control Laboratories (OMCLs), organised by the European Directorate for Quality of Medicines and HealthCare (EDQM), with participants from around 40 countries. Furthermore, the European Commission, with the aim of enhancing the institutional capacity of the Agency, approved a six-month Twinning Project. Currently, the selection process is under way for the collaborating agency from among the Member States. The Agency collaborates with similar agencies in the region; it signed a Collaboration Protocol with the Montenegrin Agency for Medicinal Products and Medical Devices, while a similar instrument is about to be signed with the Medicines Agency of Bosnia and Herzegovina. Recently, the Agency also signed a five-year Collaboration Protocol with the French Health Products Safety Agency - AFSSAPS, ensuring privileged conditions for collaboration with this institution.