Medicinal products for human use

JAZMP 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 »

The 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 »

With 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 »

Agency for Medicinal Products and Medical devices of the Republic of Slovenia (JAZMP) participates in the decentralised procedure as a RMS. JAZMP will accept to act as RMS for as …

Request for time slot for applications via DCP with Slovenia as RMS Read More »