JAZMP

Call on marketing authorisation holders to provide information about product codes (PC)

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) Več »

Letter to Marketing Authorization Holders regarding data upload in the Safety Features repository system (SiMVS)

In 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) Več »

Request for Slovenia to act as reference member state (RMS) in the procedures for marketing authorisation under MRP or DCP

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 Več »

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