Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) reiterates its invitation to marketing authorisation holders to provide information about the product codes (PC) used in the unique identifiers of medicinal products to The purpose is ensuring data connectivity and the smooth implementation of the Commission Delegated Regulation EU 2016/161.
The JAZMP collects the data and makes available the list of PCs to the interested IT providers and publishes it on its website.
Marketing authorization holders shall forward the above-mentioned information in the Excel document together with the following attributes:
– national identification code;
– name of the medicinal product;
– package size.
Marketing authorisation holders are also requested to check the correctness of the already reported PCs and their corresponding national identification codes in the table on the JAZMP website, and to report missing or incorrect data and forward any changes of the PC to the above-mentioned e-mail address.
We would like to remind marketing authorisation holders once again that when the so-called Global Trade Item Number (GTIN) is used for a PC, they must strictly comply with the standards and rules applicable to the assignment of GTINs. More information on the standards can be found at Standardi | GS1 – Globalni jezik poslovanja (gs1si.org). If you have any further questions, please contact GS1 team Slovenia.
The JAZMP also urges marketing authorisation holders to ensure that the data they upload to the system is complete, correct and in accordance with Article 33 of the Delegated Regulation of the EU Commission 2016/161, and to update it on an ongoing basis.
