Organizational Units and Bodies
Agency's organizational units
The work of the Agency is conducted through the following organizational units:
- Official Medicines Control Laboratory Division (OMCL Division)
- Medicines Authorisation Division
- Division for the Safe Use of Medicinal Products and Medical Devices
- Division for Legal, Financial, IT and General Affairs
The Directorate performs administrative and other tasks for the Head of the Agency, tasks related to communication with media representatives and legal and natural persons, tasks related to international cooperation, quality assurance system tasks, capital investment tasks, preparation and monitoring of the implementation of the annual work plan and financial plan, organization and preparation of materials related to the work and decision-making of the Administration Board. It also performs tasks related to proposing measures for the national medicinal products policy, tasks of organizing expert meetings, tasks of occupational safety and environmental protection, fire protection, tasks of maintenance of the official transportations and green areas.
The Official Medicines Control Laboratory Division (OMCL Division) performs tasks related to laboratory testing and quality control of medicinal products, medical devices and homeopathic products and counterfeits, as well as providing findings on quality control performed, providing certificates on special quality control and approval for placing an imported batch of medicinal products on the market. Through its activities, it ensures the supply of medicinal products, medical devices and homeopathic products of prescribed quality on the Croatian market. The Division cooperates with international organizations in the field of medicinal products, medical devices and homeopathic products as part of the European Official Medicines Control Laboratories Network (OMCL network) and the European Pharmacopoeia within the framework of the European Directorate for the Quality of Medicines and Healthcare (EDQM), as well as with OMCLs of other countries. The Division participates in professional and scientific meetings with topics in the field of medicinal products. The Division also participates in interlaboratory testings and samplings of medicinal products from the market.
The Medicines Authorisation Division is an organizational unit that performs the scientific and regulatory tasks in the procedures of granting, renewing, amending, revoking, transferring and suspending the marketing authorisation of medicinal and homeopathic products, as well as registration of traditional herbal and homeopathic medicinal products. These tasks include recording data on received applications, determination of the validity of applications, coordination of the procedures, expert assessment of quality, efficacy and safety of medicinal products, organisation of the Agency's Committee for Medicinal Products activities including cooperation with external experts, preparation of acts and documents and support of the functioning and development of the National Register of Medicinal Products. In addition, the Division provides expert advice and participates in the development of scientific guidelines and regulations in the field of its activities, participates in the harmonization of regulations on medicinal products with the regulations and guidelines of the European Union and international institutions, contributes to realisation of international cooperation, participates in the work of European Union bodies in the field of medicinal products, proposes measures of public interest on national medicinal products policy, performs activities related to the provision of scientific advice and other activities.
Division for the Safe Use of Medicinal Products and Medical Devices performs scientific and administrative tasks related to the granting of production licenses for medicinal products and approvals for the production of veterinary-medical products, the granting of licenses for the wholesale and retail sale of medicinal products and licenses for the intercession of medicinal products, the granting of licenses for wholesale of veterinary-medical products and granting approval for non-interventional studies. The Division performs registration in the register of manufacturers, importers and wholesalers, registration in the register of manufacturers of medical devices, registration in the register of medical devices, registration in the register of wholesalers of medical devices and granting of authorisation for retail sale of medical devices. It supervises the production of medicinal products and veterinary-medical products, supervision of pharmacovigilance, supervision of the wholesale trade of veterinary-medical products. The Division also monitors adverse reactions to medicinal products and vaccines on the Croatian market and the consumption of medicines, determines the wholesale price of medicinal product, issues certificates, opinions and consents, promotes rational pharmacotherapy, provides information and education on medicinal products and medical devices, manages records and registers, and performs other tasks in the field of medicinal products, medical devices and veterinary-medicinal products in accordance with applicable laws and regulations.
Division for Legal, Financial, IT and General Affairs performs legal, human resources, financial, accounting, IT, administrative, technical and general affairs necessary for the performance of activities and the work of the Agency, as well as documentation management and administrative affairs for the Central Ethics Committee (CEC)
Scientific Council 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, based on the proposal of the heads of the Agency's organisational units.
The Scientific Council of the Agency:
- discusses and decides on issues within the Agency's remit;
- proposes expert decisions within the registered activities of the Agency;
- proposes undertaking of expert measures aimed at improving the organisation of work and conditions for the development of Agency's activities;
- proposes measures aimed at improving the 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.
Employees' Council of the Agency
The Employees' Council of the Agency is a representative body of employees that represents the employees before the employer and protects and promotes the rights and interests of the employees.
Members of the Agency's Employees' Council are employees of the Agency for Medicinal Products and Medical Devices that are elected by the 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 matters relevant for the employees,
- ensures that the Labour law, Ordinance on labour, Collective contracts and other acts are being respected,
- ensures 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 is entitled to access the relevant documentaiton.
The Employees' Council of the Agency is elected for a period of three years, following the announcement of the official election results.
The Head of the Agency has appointed an Information Officer who deals with matters concering the right of access to information.
- Jasminka Tadin, M.A. (Journalism)
Phone: +385 1 4884 370
As part of his role, the information officer is also the public consultations coordinator.
The Head of the Agency has appointed an Ethics Commissioner who promotes ethical behaviour in interpersonal relationships among Agency's employees as well as in their interaction with clients. She receives complaints from employees and clients regarding non-ethical behaviour of employees, investigates the grounds for such 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:
- Antonela Šimunović, M.Sc. Biotech. in med.
Phone: +385 1 4884 148
Confidential person responsible for handling suspected misconduct
The Head of the Agency has appointed a confidential person responsible for handling misconduct with the aim to establish mechanisms for reporting suspected misconduct in the Agency's business operations.
Confidential person responsible for receiving suspected misconduct reports:
- Tatjana Tadić, DMD, univ. mag. med. dent.
Phone: +385 1 4884 277
Alternate confidential person responsible for receiving suspected misconduct reports:
- Božena Marković, M. Sc. (Biotechnology), univ. spec. oecoing.
Phone: +385 1 4884 244
Data Protection Officer
The Head of the Agency has appointed a Data Protection Officer who carries out the duties prescribed by the General Data Protection Regulation, such as: information and counseling of the Head of the Agency and employees performing personal data processing on their obligations; follow-up of implementation of the General Data Protection Regulation; providing advice, when requested, regarding the assessment of the effect on the protection of personal data and cooperation with the supervisory authority.
Agency's Data Protection Officer
- Jasminka Tadin, M.A. (Journalism)
Phone: +385 1 4884 103