Definition and idea
Definition of product
ATMPs are medicinal products that are based on tissues, cells or genes. A distinction is made between ATMPs and tissues/cells for transplantation depending on how the tissue/cells are processed and/or used clinically. The definition of an ATMP is a product that has been substantially manipulated or a product not intended for the same essential function in the recipient and the donor, for more information, please read Regulation 1394/2007/EC and Reflection paper on the classification of advanced therapy medicinal products (see below for non-homologous use). A typical example where a product is used for another function is when bone-marrow derived stem cells are injected in the myocardium intended for post-myocardial infarction cardiac repair. Products for treating patients with cells that have been subjected to non-substantial manipulation are not considered as ATMPs. If it is unclear whether a product is an ATMP or not, contact Läkemedelsverket and Inspektionen för vård och omsorg.
The list below (Ref: Annex 1 of Regulation (EC) No 1394/2007) describes non-substantial manipulations that, in particular, should not be considered as substantial manipulations:
- Soaking in antibiotic or antimicrobial solutions
- Cell separation, concentration or purification
Further reading for tissue/cell transplantation (not ATMP):
- Inspektionen för vård och omsorg: tissue establishment authorisation (tissue/cell transplantation not ATMP): Tissue establishment authorisation| IVO.se (in Swedish)
- Socialstyrelsen: Regulation of tissue establishment:
- Donating and procuring tissue and cells: SOSFS 2009:30 (in Swedish)
- Tissue establishment in healthcare: SOSFS 2009:31 (in Swedish)
- Using tissue and cells in healthcare for clinical research: SOSFS 2009:32 (in Swedish)
The product idea includes:
- Identifying the starting material (i.e. tissues/cells, autologous/allogenic)
- Defining the product: mode of administration and mechanism of action
- Defining the production process.