Any person applying for a licence to import medicinal products must prove that:
a system to ensure the pharmaceutical quality of medicinal products is in operation and that the company management and staff in the individual departments concerned take an active part in such a system;
each department has a sufficient number of qualified and competent staff members to enable it to achieve its quality targets;
the tasks of all persons occupying key positions in the company are set out in job descriptions and their hierarchical positions are set out in organisational charts;
a Responsible Person in accordance with Articles 17 and 18 is available;
the facilities are organised in an appropriate way;
the facilities are designed, structured, maintained and modernised regularly to guarantee the safe import of medicinal products;
a documentation system is available that comprises the working instructions, process descriptions and protocols of the relevant import procedures;
the requirements and obligations of Articles 15 and 16 are fulfilled;
the manufacturer of the medicinal products to be imported has a manufacturing licence issued by a country whose GMP control system is considered by Swissmedic to be equivalent, or which states that the medicinal products are manufactured in compliance with the GMP rules valid in Switzerland.
Any person who applies for a licence to trade wholesale in medicinal products or a licence to export medicinal products must fulfil the requirements stated in paragraph 1 letters a–h; letters f and g apply by analogy.
Swissmedic may specify further technical requirements and details.