Temporary authorisation to use medicinal products in accordance with Article 9b para. 1 TPA

On 18 March 2016, as part of the revision of the Therapeutic Products Act (TPA-2), the Swiss federal parliament approved the new Article 9b.

Art. 9b (new)     Temporary authorisation for use and for restricted placing on the market

1 The Agency may, for a limited period of time, permit certain persons or a certain group of persons outside the scope of clinical trials to use medicinal products according to Article 9 paragraph 2 letter d.
 

This article is specified in greater detail in section 5 of the Ordinance on Medicinal Products Licensing (Medicinal Products Licensing Ordinance, MPLO), which has also been revised. Following this revision it is possible, as of 1 January 2019, to grant a temporary authorisation to use medicinal products in accordance with Article 9b paragraph 1 TPA

This specifically means that patients may be treated with an as yet unauthorised product outside the scope of a clinical trial. This authorisation, which is granted by Swissmedic, is subject to several provisions, which are set out in section 5 of the revised MPLO.

The revised MPLO entered into force on 1 January 2019. Applications may be submitted to the Clinical Trials Division after obtaining the opinion of the competent Ethics Committee. For more information on the submission process to the Ethics Committee please refer to Swissethics.