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1. Each SoHO establishment shall appoint a physician who carries out their tasks in the same Member State and who shall at least fulfil the following conditions and have the following qualifications:

(a) possession of formal qualification as a physician; and (b) at least 2 years’ practical experience in the relevant field.

2. The physician referred to in paragraph 1 shall be responsible for at least the following tasks:

(a) development, review and approval of procedures for establishing and applying SoHO donor eligibility criteria, procedures for SoHO collection and criteria for the allocation of SoHO;

(b) supervision of the implementation of procedures referred to in point (a) when they are carried out by SoHO entities contracted by the SoHO establishment;

(c) the clinical aspects of investigation of suspected adverse reactions in SoHO donors, SoHO recipients and offspring from medically assisted reproduction from the perspective of the SoHO establishment;

(d) design and supervision, in collaboration with treating physicians, of clinical-outcome monitoring plans to generate evidence required to support applications for SoHO preparation authorisations pursuant to Article 39;

(e) other tasks of relevance to the health of SoHO donors, SoHO recipients and offspring from medically assisted reproduction in relation to SoHO collected or supplied by the SoHO establishment.

3. The physician may delegate the tasks referred to in paragraph 2 to other persons who shall be qualified by training and experience to perform such tasks. In such cases, those persons shall perform those tasks under the responsibility of the physician.

4. By way of derogation from paragraph 2 of this Article, where SoHO entities are authorised as SoHO establishments in accordance with Article 24(4), the physician shall be responsible for those tasks that are relevant to the SoHO activities performed by the SoHO entities and that have a direct influence on the health of SoHO donors, SoHO recipients and, where relevant, offspring from medically assisted reproduction.