- by mojca.pust@jazmp.siJAZMP is ambitious to further actively participate in assessment of marketing authorisation applications. In order to strengthen Slovenia’s position in the regulatory EU environment, one of the strategic objectives of … JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES Read More »
- by David ObranovičReport on suspected adverse reactions to veterinary medicinal products in 2021 and 2022 is available at the follwing link (in Slovenian language only)
- by David ObranovičThe European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are updating recommendations on booster doses of mRNA COVID-19 vaccines. Due to current wave of … ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines Read More »
- by mojca.pust@jazmp.siJAZMP is ambitious to further actively participate in assessment of marketing authorisation applications. In order to strengthen Slovenia’s position in the regulatory EU environment, one of the strategic objectives of … JAZMP AVAILABLE TO ACT AS REFERENCE MEMBER STATE (RMS) IN MRP AND DCP PROCEDURES Read More »
- by David ObranovičOn 23 and 24 November 2021 the Agency of the Republic of Slovenia for Medicinal Products and Medical Devices (JAZMP) will host and chair the second plenary meeting of the … SECOND MEETING OF The Heads of Medicines Agencies (HMA) during THE SLOVENIAN PRESIDENCY OF THE EU COUNCIL Read More »
- by mojca.pust@jazmp.siThe United Kingdom (UK) submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. Following … Brexit – Call on marketing authorisation holders to align marketing authorisations with the EU Pharmaceutical Acquis after the end of transition period for the United Kingdom Read More »
- by mojca.pust@jazmp.siAgency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) calls again on the Marketing Authorisation Holders to provide information about product codes (PC) used in unique … Call on marketing authorisation holders to provide information about product codes (PC) Read More »
- by JAZMPThe stabilisation period in Slovenia, introduced after the implementation of Commission Delegated Regulation 2016/161, ended on 1st of December 2019. Therefore the Agency for Medicinal Products and Medical Devices of … Call on marketing authorisation holders to provide information about product codes (PC) Read More »
- by JAZMPWe would like to inform you that R U L E S relating to fees in the field of medical devices was published in the Official Gazette of the Republic … R U L E S relating to fees in the field of medical devices published and comes into force on 27 April 2019 Read More »
- by JAZMPIn order to comply with the Falsified Medicines Directive 2011/62/EU and Delegated Regulation (EU) 2016/161, marketing authorization holders (MAHs) are responsible for ensuring that medicines marketed in the EU carry … Letter to Marketing Authorization Holders regarding data upload in the Safety Features repository system (SiMVS) Read More »
- by JAZMPBefore the implementation of Commission Delegated Regulation 2016/161 the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia calls on the marketing authorisation holders to provide information … Call on marketing authorisation holders to provide information about product codes (PC) Read More »
- by JAZMPWith this announcement we would like to inform all Applicants that the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia still has capacities to act as … Request for Slovenia to act as reference member state (RMS) in the procedures for marketing authorisation under MRP or DCP Read More »
- by JAZMPFollowing decision on the withdrawal of the United Kingdom (UK) from the European Union (EU), made at a Brexit referendum that took place in 2016, after the Article 50 of … Possibility of Slovenia’s acceptance of RMS role in MRP and DCP procedures following Brexit Read More »
- by JAZMPWith regard to ICT procurement call for JAZMP central Information System, we are publishing instructions on raising questions by potential bidders. Instructions are available here.
- by JAZMPJAZMP published 12.07.2018 the public procurement call JN0618 on »Establishment and maintenance of the Central Information System of the Agency«. Documentation is accessible on following URLs: Tenders Electronic Daily (TED) … ICT public procurement call Read More »
- by JAZMPJAZMP is offering a new online service, which facilitates more efficient communication with stakeholders. We invite all interested parties to use the new eDelivery portal (eVročanje). The portal ensures fast, … eDelivery – invitation to join Read More »
- by JAZMPGovernment of the Republic of Slovenia on its 180th regular session issued a decision on appointment of dr. Stanislav Primožič as acting director of the Agency of the Republic of … Appointment of acting director of the Agency of the RS for Medicinal Products and Medical Devices Read More »
- by JAZMPNew rules for the fees – List of Rates of JAZMP is valid from 3. 3. 2018. The instructions are available on the link: https://www.jazmp.si/en/fees/#c1534
- by JAZMPwas published in the Official Gazette of the Republic of Slovenia (No. 9/18). The tariff sets out the payment for the services provided by JAZMP for individuals and legal persons, … New fees regulation Read More »
- by JAZMPJAZMP publishes the Essential Medicinal Products List (HUM) on the web, following Minister’s approval of the List in the Slovenian Official Gazette