Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
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 »
We 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
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
Before 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 »
