FantasticSearch

1. The assessment of a SoHO preparation shall include a review of all SoHO activities that are performed for that SoHO preparation and that might influence the quality, safety and effectiveness of that SoHO preparation.

2. SoHO preparation assessors who meet the requirements set out in Article 23 shall carry out the assessment of SoHO preparations.

3. Where a SoHO preparation that is subject to an application for SoHO preparation authorisation pursuant to Article 19 has been duly authorised in another SoHO entity in the same or in another Member State, SoHO competent authorities may authorise that SoHO preparation, provided that the SoHO competent authorities have verified, with the permission of the SoHO entities concerned, that the SoHO activities performed and the steps of the processing applied for that SoHO preparation are carried out by the applicant SoHO entity in such a manner that the quality, safety and effectiveness results of the SoHO preparation will be equivalent to those demonstrated in the SoHO entity where the SoHO preparation was first authorised.

4. Where a SoHO preparation that is subject to an application for SoHO preparation authorisation pursuant to Article 19 has not been authorised in another SoHO entity, or where the SoHO competent authority chooses not to take a SoHO preparation authorisation in another Member State into account, the SoHO competent authority shall:

(a) assess the adequacy of the information provided by the applicant SoHO entity pursuant to Article 39(2), point (b);

(b) initiate the consultation provided for in Article 13, if, during the assessment of the information referred to in point (a) of this paragraph, questions arise as to whether the SoHO preparation falls, in part or fully, within the scope of this Regulation or other Union legislation, taking into account the activities performed for the SoHO preparation and the intended human application;

(c) evaluate the benefit-risk assessment carried out by the applicant SoHO entity pursuant to Article 39(2), point (c), including the scientific evidence and clinical data provided regarding the expected benefit and risk;

(d) in cases where the evidence provided in accordance with point (c) of this paragraph is not sufficient to provide certainty that the benefit outweighs the risk or where the risk is more than negligible, evaluate the plan to gather further evidence of safety and effectiveness through clinical-outcome monitoring, and the plan’s proportionality to the level of risk and expected benefit of the SoHO preparation in accordance with Article 21;

(e) consult the SCB, pursuant to Article 69(1) on the evidence necessary and sufficient for the authorisation of a particular SoHO preparation where the best practices referred to in paragraph 7 of this Article are not sufficient;

(f) assess, in the case of a clinical-outcome monitoring plan previously approved pursuant to Article 19(2), point (d), the results of the clinical-outcome monitoring upon its completion and submission of the results by the applicant.

5. When assessing the SoHO preparation pursuant to paragraph 4, points (d) and (f), SoHO competent authorities shall verify, in the cases where the applicant SoHO entity has proposed to record, and recorded, the results of the clinical-outcome monitoring in an existing clinical registry, whether that clinical registry has data quality management procedures in place that ensure adequate accuracy and completeness of data.

6. SoHO competent authorities shall conduct the assessment referred to in paragraphs 3 and 4 of this Article by means of a remote document review. SoHO competent authorities may also, as part of the SoHO preparation assessment, carry out inspections pursuant to Articles 27, 28 and 29. Pursuant to Article 12, Member States shall ensure communication and cooperation between SoHO preparation assessors and inspectors.

7. When conducting the assessment steps referred to in paragraph 4 of this Article, SoHO competent authorities shall take into account the best practices documented and published by the SCB, as referred to in Article 69(1), point (d).