Organizational Units and Bodies
Agency's organizational units
The work of the Agency is conducted through the following organisational units:
- Official Medicines Control Laboratory Division (OMCL Division)
- Medicines Authorisation Division
- Division for Safe Use of Medicinal Products and Medical Devices
- Division for Legal, Financial, IT and General Affairs
Directorate performs administrative and other tasks for the Head of the Agency; organises drafting of the materials for the Administration Board's work and decision-making; prepares and monitors implementation of annual work plans and financial plans. Directorate also performs tasks related to communication with the media representatives and legal and natural persons, as well as other tasks related to the European and international co-operation. It also implements and supervises the quality assurance system across the Agency.
Official Medicines Control Laboratory Division (OMCL Division) guarantees the supply of the Croatian market with medicinal products and medical devices of prescribed quality. This Division performs tasks related to laboratory testing and quality control of medicinal products imported into Croatia or manufactured locally, as well as those sampled off-the-shelf, from pharmacies and wholesalers. The Division cooperates with international organisations in the field of medicinal products and medical devices as part of the European Official Medicines Control Laboratories Network (OMCL network) co-ordinated by the European Directorate for the Quality of Medicines and HealthCare (Council of Europe; EDQM), as well as with laboratories from other countries. The Division prepares the Croatian Pharmacopoeia and harmonizes it with the European Pharmacopoeia.
Medicines Authorisation Division conducts all pre-authorisation procedures for domestically produced medicinal products, for the medicinal products authorised in the European Union (which can be authorised in Croatia by the nCADREAC procedures-New Collaboration Agreement between Drug Regulatory Authorities in Central and Eastern Europe) and for the medicinal products from third countries. Within the Division, there is a Department which, based on the medicinal product documentation, makes an assessment of its quality, efficacy and safety. Also, the Division is responsible for monitoring any variations to the medicinal product documentation and information throughout the five-year period of validity of marketing authorisation and renewal thereof.
Division for Safe Use of Medicinal Products and Medical Devices is focused on patient as the end user of medicinal products, as well as on healthcare professionals. It monitors adverse reactions to medicinal products and vaccines in the Croatian market and in clinical trials, promoting rational use of medicines. Furthermore, the Division is involved in preparation of various public notices, and it monitors medicines consumption, lists medical devices in the register and conducts vigilance thereof, verifies the compliance of the local manufacturers with the good manufacturing practice, issues various licenses (export/import, wholesale, retail sale in specialised shops) and finally, when necessary, recalls medicinal products and/or medical devices from the market.
Division for Legal, Financial, IT and General Affairs conducts all legal, financial, accounting, bookkeeping, administrative, human resources and general affairs that are necessary for the activities and work of the Agency.
The Scientific Council of the Agency is an advisory body to the Head of the Agency.
Members of the Scientific Council are employees of the Agency for Medicinal Products and Medical Devices appointed by the Head of the Agency on the proposal of heads of the Agency's organisational units.
Agency's Scientific Council:
- discusses and decides on the issues from the field of Agency's expertise;
- proposes expert decisions within the registered activities of the Agency;
- proposes undertaking of expert measures aimed at improved organisation of work and conditions for development of Agency's activities;
- proposes measures aimed at improved quality of the Agency's work;
- considers training needs for the Agency's staff; and
- discusses and provides opinions on expert issues at the request of the Head of the Agency.
The Employees' Council of the Agency is a representative body of employees that represents employees' rights vis-à-vis the employer and protects and promotes employees rights and interests.
Members of the Agency's Employees' Council are employees of the Agency for Medicinal Products and Medical Devices that are elected by Agency's employees.
The Employees' Council of the Agency:
- protects and promotes employees' interests vis-à-vis the employer, by advising, co-deciding or negotiating with the employer or his appointed representative, on issues important for employees position
- watches that the Labour law, Ordinance on labour, Collective contracts and other acts are being respected
- watches that the employer duly and precisely fulfills his obligations with respect to accounting and settelment of contributions according to special legislation and in that respect has a right of access to respective documentation
The Employees' Council of the Agency is elected for a three years period.
Head of Agency has appointed an Information Officer that deals with issues of rights of access to information.
- Jasminka Tadin, M.A. (Journalism)
Phone: +385 1 4884 103
Head of Agency has appointed an Ethics Commissioner who promotes ethical behaviour in interpersonal relationships among Agency's employees as well as behaviour of employees towards clients. He receives complaints from employees and clients on non-ethical behaviour and acting of employees and is responsible for investigating grounds for complaints and runs a registry of received complaints.
Agency's Ethics Commissioner:
- Maja Bašić, M.A. (Political Science)
Phone: +385 1 4884 371
Agency's Ethics Commissioner Alternate:
- Vladimir Mihalic, M.Pharm.
Phone: +385 1 4884 264
Person responsible for handling suspected misconduct
Head of Agency has appointed a person responsible for handling misconduct with the aim to establish mechanisms for reporting suspected misconduct in the Agency's business operations.
Person responsible for receiving suspected misconduct reports:
- Andrea Došlić, M.Ec.
Deputy Head for Resources
Phone: +385 1 4884 151