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1. SoHO preparation assessors shall:

(a) possess a diploma, certificate or other evidence of formal qualifications in the field of medical, pharmaceutical or life sciences, awarded on completion of a university course of study or a course recognised as equivalent by the Member State concerned;

(b) have expertise in the processes being assessed or the human applications for which the SoHO preparations will be used.

2. The assessment of SoHO preparations referred to in Article 20 may be done jointly by a team of persons which collectively have the qualifications and experience set out in paragraph 1 of this Article.

3. In exceptional cases, SoHO competent authorities may consider that a person’s considerable and relevant experience exempts that person from the requirements set out in paragraph 1.

4. Before SoHO preparation assessors take up their duties, SoHO competent authorities shall provide SoHO preparation assessors with a specific induction training on the procedures to be followed for the assessment of SoHO preparations in accordance with Articles 20 and 21.

5. SoHO competent authorities shall ensure that the specific induction training is complemented by specialised training for assessment of processing methods and technologies used for specific types of SoHO preparations, as well as by continuous training, as appropriate, throughout the career of the SoHO preparation assessors. SoHO competent authorities shall make all reasonable efforts to ensure that SoHO preparation assessors participating in joint SoHO preparation assessments have completed the relevant Union training referred to in Article 70(1) and are included in the list referred to in Article 70(5).

6. SoHO preparation assessors may be assisted by technical experts provided that SoHO competent authorities ensure that those experts comply with the requirements of this Regulation, in particular with those set out in Articles 6, 75 and 76.