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

    |     Obvestila za imetnike dovoljenj za promet,   Zdravila za uporabo v humani medicini

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 the Republic of Slovenia calls again on the marketing authorisation holders to provide information about product codes used in unique identifiers on medicinal products placed on the market in the Republic of Slovenia.

Information should be sent to the e-mail address safety.features@jazmp.si.

 

Marketing authorization holders should provide the above mentioned information in the Excel document together with the following attributes:

-     national identifier

-     name of the medicinal product

-     packaging,

 before placing the medicinal product on the market.

 

Marketing authorization holders should also notify any changes of the product codes, to the above mentioned e-mail address.