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3. The applicant SoHO establishment shall provide:

(a) documentation of the accreditation, designation, authorisation or licence granted by a competent authority or authorities to the third-country supplier for carrying out the activities related to the SoHO to be imported;

(b) a written agreement as referred to in paragraph 2 that shall include, at least:

(i) details of the third-country supplier contracted;

(ii) the requirements to be met to ensure the equivalence of the quality, safety and effectiveness of the SoHO to be imported;

(iii) the right of the SoHO competent authorities to inspect the activities, including the facilities, of any third-country supplier or entity sub-contracted by that supplier, contracted by the importing SoHO establishment;

(c) documentation describing the imported SoHO and demonstrating that the procedures the third-country suppliers have in place will ensure that the imported SoHO will be equivalent, in terms of quality, safety and effectiveness, to SoHO authorised in accordance with this Regulation.

4. The importing SoHO establishment shall be responsible for the physical reception and visual examination and verification of imported SoHO prior to their release. The importing SoHO establishment shall verify coherence between the SoHO received and the associated documentation and conduct an examination of the integrity of packaging, labelling and transport conditions, taking into account the relevant standards and technical guidelines as referred to in Articles 57, 58 and 59.

5. The releasing officer of an importing SoHO establishment shall release imported SoHO for distribution only after that officer has verified compliance with the quality, safety and effectiveness requirements specified in the agreement referred to in paragraph 3, point (b), and when the physical and documentation controls referred to in paragraph 4 are satisfactory.

6. An authorised importing SoHO establishment may delegate the physical reception, visual examination and verification referred to in paragraph 4 to the SoHO entity that will apply the SoHO to a SoHO recipient in cases where the import of SoHO is organised for a specific SoHO recipient.

In the case of national or international donor registries that are authorised as importing SoHO establishments, the physical and documentation controls referred to in paragraph 5 may be delegated to the SoHO entity that receives the imported SoHO for human application and the release step may be completed remotely.

7. The Commission shall adopt implementing acts specifying the information to be provided in an application for an importing SoHO establishment authorisation to ensure compatibility and comparability of such data. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79(2).

1. Article 46 shall apply mutatis mutandis to the applications for importing SoHO establishment authorisations.

2. Prior to applying for an importing SoHO establishment authorisation, SoHO establishments shall put in place written agreements with one or more third-country suppliers. Such agreements shall include the elements set out in paragraph 3, point (b).