About the agency

AGENCY FOR MEDICINAL PRODUCTS AND MEDICAL DEVICES OF THE REPUBLIC OF SLOVENIA (JAVNA AGENCIJA ZA ZDRAVILA IN MEDICINSKE PRIPOMOČKE - JAZMP) was formed on 1. Jan. 2007 by merger of Agency for Medicinal Products and Medical Devices (Agencija za zdravila in medicinske pripomočke - ARSZMP), which operated under the Ministry of Health, and National Institute for Pharmacy and Drug Research (Zavod za farmacijo in za preizkušanje zdravil - Ljubljana - ZAF). JAZMP as a new legal person assumes the rights and obligations of ARSZMP and ZAF. 

General information

MANAGEMENT AND ORGANISATIONAL UNITS

Organization chart 

Management

Martina Cvelbar, MPharm, PhD - Director
Vesna Koblar, MD, PhD - Deputy Director
Andrej Degen, PhD - Quality Manager
Renata Rangus Čermelj - Executive Secretary to the Director

Regulatory Sector for Medicinal Products for Human Use

Sabina Zalar, MPharm - Head of Sector
Maja Lušin, MPharm, MSc - Head of Regulatory Affairs Department
mag. Ana Videnšek Podgorelec, mag. farm. - Head of MRP / DCP procedures unit
Marjeta Jordan, mag. farm. - Head of National procedures unit
mag. Gabriela Jazbec, mag. farm., spec. - Head of Scientific evaluation unit
Not occupied - Head of Regulatory support unit
Barbara Razinger Mihovec, MPharm, MSc - Head of Department for Herbal, Traditional and Homeopathic Medicinal Products
Milena Radoha Bergoč, MPharm - Head of Pharmacovigilance Department

Regulatory Sector for Medicinal Products for Veterinary Use

Katarina Štraus, DVM, MSc - Head of Sector

Sector for Medical Devices

Romana Kajdiž, MA - Head of Sector

Sector for Pharmacoeconomics

Assoc. Prof. Stanislav Primožič - Head of Sector

Pharmaceutical Inspection

Anton Kramarič, MPharm, PhD - Head of Sector

Sector for Medicines Quality Control

Daniela Planinšek, MPharm, MSc - Head of Sector
Metka Stojičević, MPharm, MSc - Head of Official Medicines Control Laboratory
Irena Kuhelj, MPharm, MSc - Head of Analytical Laboratory
Tanja Tekavčič Glover, MPharm - Head of Pharmacopeial Department

Secretariat

Barbara Kovač, J.D. - Head of Secretariat
Mirjam Jezeršek, BA - Head of Main Office
Marija Pipan, J.D. - Head of Legal, Personnel and General Affairs Department
Mojca Rak, MA - Head of Department for Finances, Accounting and Public Procurement
Uroš Rezar, MSc - Head of IT Department

TASKS AND RESPONSIBILITIES OF THE JAZMP

Tasks in the field of medicinal products and medical devices

• administrative, expert and developmental tasks in the fields of medicinal products and medical devices for human and veterinary use, except the determination of doctrinal solutions on the level of safe use of medicinal products for veterinary use, related to veterinary medicine;
• inspection tasks in the field of medicinal products and medical devices, except the control of the marketing of medicinal products for veterinary use, related to veterinary medicine,
• tasks of the official control laboratory;
• executive tasks and decision-making in national and EU-harmonized administrative and regulatory processes of quality evaluation, safety and efficacy of medicinal products and medical devices;
• tasks of establishing, upgrading and updating of the regulatory information system and keeping official records based on the legislation;
• tasks related to the pharmacovigilance and materiovigilance system;
• tasks related to the establishment of an internationally identifiable system of quality of operation within the framework of good regulatory practice;
• tasks related to pricing, and price analysis for medicinal products and their impact on the market operation;
• professional support for implementation of the systemic orientation in the field of medicinal products and medical devices;
• tasks including the collaboration with other regulatory, professional and scientific institutions.;
• regulatory and scientific tasks in the field of vigilance system;
• regulatory and scientific tasks related to admission and import of medicinal products characterized as illegal drugs;
• tasks related to the pharmacopoeial laboratory and collaboration in upgrading the European Pharmacopoeia and release of the national annex to the European Pharmacopoeia;
• collaboration with the delegations of the Republic of Slovenia in expert bodies and working groups in the Council of the European Union and European Commission in the field of medicinal products and medical devices;
• collaboration in the European network of the official medicines control laboratories;
• collaboration in the network of competent authorities for medicinal products and medical devices in the European Union;
• collaboration with other state authorities in the field of human and veterinary medicine;
• collaboration with other competent authorities for medicinal products and medical devices in third countries;
• collaboration with associations of the users of agency's services and other organisations;
• collaboration in the preparations of regulations in the field of medicinal products and medical devices;
• providing information and counselling services in the field of medicinal products and medical devices;
• education in the field of medicinal products and medical devices;
• developing of analytical methods and analytical testing of medicinal products;
  
• other expert tasks related to the purpose of its formation.

Tasks in the field of blood supply

• collection of information from transfusion services and centres on severe adverse events related to collection, testing, processing, storing, distribution and use of blood and blood components;
• collection of reports from transfusion services and centres on severe adverse reactions during or after transfusion, which could be attributed to the quality and safety of blood and blood components;
• reporting to the European Commission on the performed activities in the field of haemovigilance;

Tasks in the field of quality and safety of human tissues and cells:

• procedures for authorisation for collecting, testing, preparation, processing, storing and/or distribution of blood and blood preparations, authorisations for obtaining, testing, processing, conservation, storing and/or distribution of human tissues and cells, intended for treatment.
• procedures for authorisation of importing/admission or exporting/removal of human tissues and cells on the proposal of Slovenia - Transplant.
• collection of reports from donor centres on severe adverse events and reactions, and reports on the analyses of causes and effects, related to obtaining, testing, processing, storing, allocation and distribution of tissues and cells, as well as the observing any adverse reactions during or after clinical use, which could be related to the quality and safety of tissues and cells;
• reporting to the European Commission at its request on activities undertaken in the field of histovigilance.

LEGISLATION

Medicinal Products Act (Official Gazette of the RS, no. 31/06, 45/08)

Medical Devices Act (Official Gazette of the RS, no. 101/99; 70/00;7/02; 13/02-Zkrmi; 67/02; 74/04-ZdZPZ; 31/06-ZZdr-1)

Blood Supply Act (Official Gazette of the RS, no. 104/06)

Act on Quality and Safety of Human Tissues and Cells (Official Gazette of the RS, no. 61/07)

PUBLIC INFORMATION

Contact persons:
Marija Pipan, J.D.
Mateja Kuhelj, J.D.