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1. SoHO competent authorities shall provide guidelines and templates to allow that applications for SoHO establishment authorisations are submitted in accordance with Article 46. When developing those guidelines and templates, SoHO competent authorities shall take into account the relevant best practices documented and published by the SCB, as referred to in Article 69(1), point (d). SoHO competent authorities may use the secure communication channel on the EU SoHO Platform for the exchange, with the SoHO establishment, of documents relating to the application for a SoHO establishment authorisation.

2. Upon receipt of an application for a SoHO establishment authorisation, SoHO competent authorities shall:

(a) acknowledge receipt of the application without undue delay;

(b) assess the application;

(c) examine agreements between the applicant SoHO establishment and any SoHO entities contracted by that SoHO establishment to perform SoHO activities;

(d) request the applicant SoHO establishment to provide supplementary information, if needed;

(e) carry out an on-site inspection of the applicant SoHO establishment pursuant to Article 27, and, where applicable, of SoHO entities or third parties contracted by the SoHO establishment pursuant to Article 28;

(f) inform the applicant SoHO establishment, without undue delay, of the outcome of the assessment and inspections referred to in points (b), (c) and (e), and in point (d), where relevant;

(g) grant or refuse the authorisation of the applicant SoHO establishment as a SoHO establishment, as appropriate, and indicate which SoHO and which SoHO activities for each SoHO are subject to the authorisation and which conditions apply, if any;

(h) submit information regarding the authorisation granted in respect of the SoHO establishment, by amending the status of the SoHO entity to SoHO establishment on the EU SoHO Platform without undue delay;

(i) assess and, as appropriate, authorise any significant changes made by the SoHO establishment to the information provided in the application and communicated to them pursuant to Article 46(2), and update that information on the EU SoHO Platform.

3. SoHO competent authorities may, in accordance with national legislation, suspend the SoHO establishment authorisation, or the authorisation of certain SoHO activities which the SoHO establishment is authorised to perform, where SoHO supervisory activities demonstrate, or give reasonable grounds for suspecting that the SoHO establishment concerned does not comply with the conditions of its authorisation or with this Regulation. SoHO competent authorities shall, in accordance with national legislation, suspend the SoHO establishment authorisation when an imminent risk to the safety of SoHO donors, recipients or offspring from medically assisted reproduction, or an imminent risk of unnecessary wastage of critical SoHO, is identified. SoHO competent authorities shall specify a period of time for the investigation of a suspected non-compliance and for the SoHO establishment to rectify a confirmed non-compliance, during which the suspension will remain in place.

4. In cases where SoHO competent authorities have confirmed cases of non-compliance as referred to in paragraph 3 and SoHO establishments are not able to rectify them in the specified time period, SoHO competent authorities shall, in accordance with national legislation, withdraw the authorisation of those SoHO establishments.

5. SoHO competent authorities may, in accordance with national legislation, withdraw the SoHO establishment authorisation if a suspension, as referred to in paragraph 3, is not sufficient to resolve the identified shortcomings.

6. In cases of suspension or withdrawal of a SoHO establishment authorisation, as referred to in paragraphs 3, 4 and 5, SoHO competent authorities shall, without undue delay, amend accordingly the authorisation status of the SoHO establishment concerned on the EU SoHO Platform.