Hospital Exemption
DEFINITION
The purpose of the Hospital Exemption (HE) LVFS 2011:3 (in Swedish) is to provide an ATMP without marketing authorisation. HE is to be used in hospital when there is high unmet medical need and for an individual patient under the exclusive professional responsibility of a medical practitioner. This may include any ATMP manufactured under GMP:
- On a non-routine basis
- According to specific quality standards
- On an individual patient basis
- Used in the same EU member state.
LEGAL FRAMEWORK
- Manufacturing of the HE must be authorised by the Läkemedelsverket and according to GMP
- Tissue establishment authorisation: LVFS 2011:4 (in Swedish) LVFS 2008:12 (in Swedish)
- Manufacturing authorisation for HE: LVFS 2011:3 (in Swedish)
- A qualified person (QP) is needed; the necessary qualifications and responsibilities are described in LVFS 2004:7and also in GMP vol. 4 Annex 16
- Any adverse events that occur during a treatment under HE must be reported to Läkemedelsverket according to LVFS 2012:14 (in Swedish)
- Ethical permission is not required but strongly recommended. Detailed information on the application procedures for ethical review of clinical trials in Sweden (in Swedish) is available on the Etikprövningsmyndigheten (EPM)