Notices to marketing authorization holders

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

The 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 Več »

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 »

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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