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 »
