There has been a growing trend in recent years towards the development of new therapeutic approaches with products which, unlike industrially produced medicines, are not standardised on the basis of their origin or biological characteristics, but rather are manufactured as patient-specific preparations. To this end, substances from the patients' own bodies or from animals are frequently processed into a product, and the resulting manufactured preparations are then used on the same person or on a small number of patients. Since such preparations have always been classified as medicinal products, they are basically subject to the need for authorisation in accordance with Art. 9, para. 1 of the Therapeutic Products Act (TPA, SR812.21) unless they fall under the exemption ruling stated in Art. 9 para. 2 TPA. This exemption ruling covers all formula-related medicinal products, clinical trial preparations and non-standardised medicinal products.
Following the revision of the Therapeutic Products Act at the start of 2019, the legislator has extended the options for classifying preparations as non-standardised medicinal products. As a result, certain patient-specific preparations can now be classified as non-standardised medicinal products according to Art. 9 para. 2 let. e TPA.
Non-standardised medicinal products
Patient-specific preparations often cannot be standardised to the same extent as normal medicinal products on the basis of their origin or biological variability. They cannot therefore be defined as formula-related medicinal products since, although manufactured for specific patients according to a prescription, unlike formula-based preparations they are not usually obtained and/or manufactured according to a standardised process. They are usually not produced in public or hospital pharmacies, as is the case for formula-based preparations.
The following preparations or groups of preparations are currently classified as non-standardised medicinal products according to Art. 9 para. 2 let. e TPA:
- Labile blood products such as packed red blood cells, plasma for transfusion, platelet concentrates
- Serum eye drops
- Organ cell extracts of animal origin
- Faecal microbiota preparations (from one or more healthy donors for predefined patients)
- Platelet-rich plasma (PRP)
- Platelet-rich fibrinogen
- Orthokine
- Herd-specific animal autovaccines
Non-standardised transplant products are not listed here.
This new classification replaces an earlier interpretation and classification, based on therapeutic products legislation, of certain autologous serum preparations (see Swissmedic Journal 4/2012, S.334 f.).
The manufacture and dispensing of non-standardised medicinal products that are not listed here or in the list in Annex 3 of the Ordinance on the Simplified Licensing of Therapeutic Products and the Authorisation of Therapeutic Products by the Notification Procedure (TPLO; SR812.212.23) are not exempt from regulatory oversight, but their manufacture is subject to cantonal requirements.
Establishment licence for the manufacture of non-standardised medicinal products
Since non-standardised medicinal products clearly differ from formula-based preparations, their manufacture and distribution require an establishment licence issued by Swissmedic. They must be manufactured according to the GMP requirements stated in Annex 1 of the Ordinance on Licensing in the Medicinal Products Sector (MPLO; SR 812.212.1).
Mandatory authorisation for extraction and manufacturing processes
Based on the revised Therapeutic Products Act, Swissmedic classifies certain medicinal products that have an inadequately known safety or efficacy profile or pose an increased risk due to their composition, dosage or application as “non-standardised”. In order to protect patients and animals, mandatory authorisation has now been introduced for certain non-standardised medicinal products. Annex 3 TPLO contains a list of those medicinal products whose extraction or manufacturing processes have been subject to this mandatory authorisation as of 01.07.2020. The list is published by Swissmedic.