ADVANCED THERAPY MEDICINAL PRODUCTS PREPARED ON A NON-ROUTINE BASIS

Non-routinely prepared advanced therapy medicinal products (i.e. hospital exemptions) are medicinal products belonging to one of the following groups: gene therapy medicinal products, somatic cell therapy medicinal products, tissue engineered products or combined advanced therapy medicinal products.

Non-routinely prepared advanced therapy medicinal product is determined by the preparation process, route of administration and therapeutic indication.

Where blood, cells or tissues are starting materials for non-routine preparation of an advanced therapy medicinal product, all necessary steps must be taken to ensure alignment with the national requirements on the quality, traceability and pharmacovigilance of the non-routinely prepared advanced therapy medicinal product;  i.e., from donor’s starting materials to the preparation of the non-routinely prepared advanced therapy medicinal products, and from the release of the finished product to the use of the non-routinely prepared advanced therapy medicinal product for the treatment of an individual patient.

The field of non-routine preparation of advanced therapy medicinal product and its use is regulated in the Republic of Slovenia by the Medicinal Products Act (Medicinal Products Act (ZZdr-2) (PISRS) with Chapter V, with Articles 71 to 86.d.

More information about advanced therapy medicinal products you can find at https://www.jazmp.si/en/human-medicines/advanced-medicinal-products-atmp/.