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1. SoHO competent authorities shall authorise as importing SoHO establishments those SoHO entities that import SoHO, as referred to in Article 24(2).

2. Article 24(1), (3) and (5) and Article 25 shall apply, mutatis mutandis, to the authorisation of importing SoHO establishments.

3. Upon receipt of an application for an importing SoHO establishment authorisation, SoHO competent authorities shall act in accordance with Article 25(2). SoHO competent authorities shall also assess the procedures in place at the applicant importing SoHO establishment to ensure that the imported SoHO are equivalent, in terms of quality, safety and effectiveness, to SoHO preparations authorised in accordance with this Regulation.

4. With regard to Article 25(2), point (e), and in cases where the imported SoHO are not physically received by the importing SoHO establishment but are sent directly to the SoHO entity for human application to a specific SoHO recipient or to an operator for manufacturing a product regulated by other Union legislation, as referred to in Article 2(6), SoHO competent authorities may choose to carry out an inspection by means of remote document review.

5. SoHO competent authorities may require to inspect any third-country supplier to the applicant importing SoHO establishment prior to granting or refusing the importing SoHO establishment authorisation, in particular in cases where the application concerns regular and repeated import of SoHO from the same third-country supplier.

6. By way of derogation from paragraph 1, SoHO competent authorities may authorise imports of SoHO for immediate human application to a specific SoHO recipient, when requested by the SoHO entity responsible for that human application and when duly justified by the clinical circumstances on a case-by-case basis. SoHO competent authorities may also authorise imports of SoHO in emergency situations for immediate human application to SoHO recipients whose health would be seriously endangered without such an import of SoHO.

7. The Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down specific criteria for the assessment of the applications in the course of the authorisation of importing SoHO establishments.

8. Where, in the case of risk to quality and safety of imported SoHO, imperative grounds of urgency so require, the procedure provided for in Article 78 shall apply to delegated acts adopted pursuant to this Article.