FantasticSearch

1. By way of derogation from Article 19, SoHO competent authorities may permit, at the request of a SoHO entity as referred to in Article 38(3) and duly justified by a health emergency situation, the distribution, or preparation for immediate human application, of SoHO preparations within their territory even if the procedures referred to in Article 19 have not been carried out, provided that:

(a) the human application of those SoHO preparations is in the interest of public health;

(b) the SoHO preparations have a level of quality and safety that is acceptable considering the requirements of this Regulation or the available data indicate a positive benefit-risk assessment; and (c) the SoHO preparation is for immediate human application to a defined group of SoHO recipients, who have no therapeutic alternative, the treatment cannot be postponed, the prognosis is life-threatening and the expected benefit outweighs the risks.

The intended SoHO recipients or, where applicable, persons granting consent on their behalf, shall be informed of the derogation and shall give their consent to the immediate human application of that SoHO preparation, in accordance with national legislation, prior to the human application itself.

2. SoHO competent authorities shall:

(a) indicate the period of time for which the permission referred to in paragraph 1 is granted and if such SoHO preparations may be distributed to other Member States;

(b) instruct the requesting SoHO entity to submit an application for a SoHO preparation authorisation pursuant to Article 39 and collect retrospectively data on the human application of the SoHO preparation during the health emergency situation;

(c) inform the SoHO national authority of the permission referred to in paragraph 1, provided for the SoHO preparation concerned.

3. The SoHO national authority shall inform the Commission and the other Member States via the EU SoHO Platform of any decision to permit the distribution, or preparation for immediate human application, of SoHO preparations in accordance with paragraph 1.

4. In cases where such SoHO preparations might be distributed to other Member States, the SoHO national authority of the receiving Member State shall confirm the validity of the permission within its territory before the distribution takes place.