The Agency is responsible for inspections carried out in Switzerland subject to the reservations of Articles 30 and 34 paragraph 4.
It is responsible for the inspections specified in Articles 6, 19 and 28 in the following sectors:
immunological medicinal products;
blood and blood products;
rarely used procedures which require very specific and specialised knowledge.
It shall delegate the inspections referred to in Articles 6, 19 and 28 in all other sectors to the cantonal inspectorates insofar as they satisfy the requirements of federal legislation and international law applicable in Switzerland.
It may involve the cantonal inspectorates in, or ask them to carry out inspections within its area of competence.
The cantons may involve regional or other cantonal inspectorates or the Agency in, or ask them to carry out the inspections referred to in paragraph 3.
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