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; organizes drafting of the materials for the Administration Board's work and decision-making; prepares and monitors the implementation of annual work plans and financial plans. It also performs tasks related to communication with 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.
The 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 harmonises it with the European Pharmacopoeia.
The Medicines Authorisation Division is an organizational unit that performs 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 Medicines Authorisation 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 in accordance with the Medicinal Products Act and regulations adopted pursuant to the Medicinal Products Act. The following departments have been established to perform the tasks of the Division: Department for Validation of Applications; Regulatory Affairs Department; Department for Quality Assessment; Department for Safety and Efficacy Assessment and Scientific Advice Office.
Division for the 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. It monitors adverse reactions to medicinal products and vaccines on the Croatian market and in clinical trials, promoting rational use of medicines. Furthermore, the Division is involved in preparing various public announcements, it monitors the consumption of medicines, enters medical devices in the register and conducts the vigilance of medical devices, verifies the compliance of local manufacturers with Good Manufacturing Practice, issues various licenses (export/import, wholesale, retail sale in specialised store) 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.
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