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1. SoHO competent authorities shall establish and maintain a system for granting SoHO preparation authorisations to SoHO entities located in their territory. Such a system shall include the reception and processing of applications and the approval of clinical-outcome monitoring plans to generate the evidence required for authorisation, where necessary, and shall allow for the suspension or withdrawal of authorisations.

2. SoHO competent authorities shall authorise SoHO preparations in accordance with Articles 19, 20 and 21 and, where applicable, Article 22.

3. The requirement of SoHO preparation authorisation shall be waived for SoHO that are intended to be distributed for the manufacture of products regulated by other Union legislation, as referred to in Article 2(6).

4. SoHO preparation authorisations shall be valid throughout the Union for the period set out in the authorisation granted pursuant to Article 19(2), point (e), or until the SoHO competent authority has suspended or withdrawn the authorisation. Where a Member State has adopted a more stringent measure in accordance with Article 4, which relates to a specific SoHO preparation, that Member State may decline to recognise the validity of the SoHO preparation authorisation of another Member State until the SoHO entity authorised for that SoHO preparation has demonstrated to that Member State compliance with that more stringent measure.