Licence for the preparation of a non-routinely prepared medicinal product

A business entity with its head office in the Republic of Slovenia can only prepare non-routinely prepared advanced therapy medicinal products based on and in accordance with the licence for the preparation of non-routinely prepared advanced therapy medicinal products, issued by the relevant authority.

The procedure for the issue of the licence for non-routinely prepared advanced therapy medicinal products is initiated with an application submitted by the applicant with its head office in the Republic of Slovenia, i.e. for the preparation of an individual type of non-routinely prepared advanced therapy medicinal products, separately for:

  •  medicinal products for genetic treatment,
  • medicinal products for somatic cell treatment and
  • tissue engineering products by indicating individual medicinal products in the group.
The relevant authority issues or rejects the issue of the licence for non-routinely prepared advanced therapy medicinal products within 180 days from the receipt of a complete application based on the expert committee's opinion for establishing the fulfilment of conditions for the performance of the activity of preparation of non-routinely prepared advanced therapy medicinal products and, if necessary, from external independent experts in genetic treatment, cell treatment and tissue engineering, i.e. on the fulfilment of prescribed conditions.

Legal protection

  • Judicial remedy: Appeal
  • Competent authority: Ministry of Health

Legal basis/grounds

Last updated: 11. 02. 2016