Preparation of non-routine medicinal products for advanced therapy

 A non-routinely prepared medicinal product for advanced therapy is any medicinal product for advanced therapy which is non-routinely prepared in the Republic of Slovenia in accordance with the prescribed standards of quality, and used in the Republic of Slovenia by a health-care service provider or a veterinary service provider which

  • performs health-care services, with the provider having the exclusive professional liability in accordance with an individual order for an individual non-routinely prepared medicinal product for advanced therapy for an individual patient,
  • or which performs veterinary services, with the provider having the exclusive professional liability in accordance with an individual order for an individual animal or a group of animals from the same holding.


A business entity which prepares non-routinely prepared medicinal products for advanced therapy must fulfil the following conditions:

  • employ an adequate number of experts with adequate education, considering the scope and complexity of preparation of non-routinely prepared medicinal products for advanced therapy;
  • have adequate premises, devices and equipment for the preparation, control, storage and transport of non-routinely prepared medicinal products for advanced therapy;
  • appointing a person among the expert staff responsible for quality of non-routinely prepared medicinal products for advanced therapy who is responsible for ensuring that the preparation of non-routinely prepared medicinal products for advanced therapy is carried out in accordance with the existing legislation;
  • have a quality system which is regularly updated within reason, considering the principles and guidelines of good production practice;
  • take into account the specific characteristics of a non-routinely prepared medicinal product for advanced therapy; consider the produced risk assessment and ensure the minimum standards determined in the Republic of Slovenia with regulations on the supply of human tissue and cells intended for treatment;
  • have adequate contracts concluded with business entities which supply materials and services which affect the quality and safety of non-routinely prepared medicinal products for advanced therapy in which the responsibilities, tasks and professional expertise of all contractual parties are precisely defined;
  • in accordance with good distribution practice, provide adequate transport for transporting non-routinely prepared medicinal products for advanced therapy to the client.


In the preparation and use of non-routinely prepared medicinal products for advanced therapy which contain or are made of human tissue or cells, complete traceability from the donor to the recipient must be ensured.

A non-routinely prepared medicinal product for advanced therapy in human or veterinary medicine may be prepared by a business entity which holds a permit from the competent authority for the preparation of a non-routinely prepared medicinal product for advanced therapy in accordance with the quality standards or conditions for preparation determined by the relevant law, within the limits of the issued permit.

A non-routinely prepared medicinal product for advanced therapy is prepared on the basis of an individual written order from a physician or veterinarian, which is a type of medical or veterinary prescription with which a physician or veterinarian prescribes a non-routinely prepared medicinal product for advanced therapy for the treating a patient or animal at a health-care or veterinary care service provider.

A holder of a permit for the preparation of a non-routinely prepared medicinal product for advanced therapy must not:

  • prepare non-routinely prepared medicinal products for advanced therapy which are not covered by the permit for the preparation of non-routinely prepared medicinal products for advanced therapy;
  • prepare non-routinely prepared medicinal products for advanced therapy at locations and in facilities which are not listed in the permit for the preparation of non-routinely prepared medicinal products for advanced therapy;
  • prepare non-routinely prepared medicinal products for advanced therapy in premises which are not listed in the documentation which was the basis for issuing the permit for the preparation of non-routinely prepared medicinal products for advanced therapy;
  • perform other activities on the same premises if it has failed to obtain consent from the competent authority;
  • prepare non-routinely prepared medicinal products for advanced therapy which contain human tissue or cells if the donation and acquisition of human tissue and cells and the testing of donors of human tissues and cells was not performed in accordance with the existing regulations;
  • prepare non-routinely prepared medicinal products for advanced therapy for the purpose of clinical testing.


Conditions and evidence

Last updated: 18. 12. 2015