Entry in the register of persons responsible for the release of medicinal products

An application for the entry in the register of persons responsible for the release of medicinal products may be submitted by applicants for the acquisition of a manufacturing authorisation and holders of a manufacturing authorisation for medicinal products in the Republic of Slovenia.

The competent authority enters the person responsible for the release of individual series of medicinal products within eight days of the receipt of a complete application, and issues a certificate thereof at the request of the applicant.

An administrative fee of EUR 4.54 must be paid for the entry in the register and issue of the certificate.

The competent authority keeps a publicly accessible register of persons responsible for the release of individual series of medicinal products.

Last updated: 08. 01. 2016