Year: 2019

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 »

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