Annex 6

(Art. 53 para. 1)

Documentation required for a temporary licence to use medicinal products in accordance with Article 9b paragraph 1 TPA

1. Application for a temporary licence for use, including a reference to one or more clinical trials approved by the competent Ethics Committee and Swissmedic.
2. Description of the project, including justification of use outside the context of clinical trials, with a benefit-risk assessment for the patients and reference to the Investigator’s Brochure (IB).
3. Updated reference IB, including risk assessment data.
4. Confirmation by the sponsor that the medicinal product is identical to the product used in the reference clinical trial.
5. Information provided to the patients, specifically concerning the special status of the medicinal product.
6. If relevant, decisions on compassionate use by the European Medicines Agency or by a country with a comparable regulatory system (Art. 13 TPA), including any conditions imposed and their justification.
7. Agreement between the sponsor and the treating physician defining their respective responsibilities.
8. Preliminary Ethics Committee decision.