¹ The Responsible Person must have the necessary technical knowledge and be trustworthy. They must also fulfil the following professional requirements:

a.

for the manufacture of ready-to-use medicinal products or intermediate products, the Responsible Person must be a qualified pharmacist with professional experience;

b.

for the manufacture of labile blood products or immunological medicinal products the Responsible Person must have a university degree in medicine or a life science and have the necessary professional experience;

c.

for the manufacture of active pharmaceutical ingredients or medicated feedingstuffs, the Responsible Person must have a university degree in a life science and the necessary professional experience;

d.

for the manufacture of radiopharmaceuticals, the Responsible Person must have a certificate issued by the European Association of Nuclear Medicine for Radiopharmacy and have the necessary experience.

² If a person can prove sufficient knowledge and experience, Swissmedic may also recognise other professional qualifications for this job.

³ Swissmedic may specify further details to Article 5 and this Article, in particular the minimum number of hours during which the Responsible Person must be present in the facility and the requirements that they must fulfil in terms of training and experience.