¹ The Agency shall make provision for simplified procedures for the authorisation of certain categories of medicinal products where this is compatible with the quality, safety and efficacy requirements, and where there is no conflict with Swiss interests or international agreements. In particular, this applies in the case of:

a.

medicinal products made with known active substances;

a^bis.⁵⁰

medicinal products whose active substances are used in a medicinal product which, when the application was submitted, has been authorised as a medicinal product for at least 10 years in at least one EU or EFTA country and which is comparable in terms of indications, dosage and method of administration;

a^ter.⁵¹

non-prescription medicinal products with indications which, when the application was submitted, have been proven to have been used medically for at least 30 years, and for at least 15 years in EU and EFTA countries;

a^quater.⁵²

medicinal products which, when the application was submitted, have been authorised as medicinal products for at least 15 years in a canton;

b.⁵³

complementary medicines;

c.⁵⁴

...

c^bis.⁵⁵

herbal medicines;

d.⁵⁶

medicinal products prepared by a hospital pharmacy or in the hospital’s own radiopharmaceutical unit for the needs of the hospital;

e.

medicinal products prepared by the army and used in the context of the coordinated army medical corps;

f.

important medicinal products for rare diseases;

g.

veterinary medicinal products, which are intended exclusively for animals not kept for the production of foodstuffs.

² The Agency shall make provision for a simplified authorisation procedure in the case of an application from another person responsible for the placing on the market of a medicinal product which is already authorised in Switzerland and which is imported from a country with an equivalent authorisation system:

a.

if the medicinal product satisfies the same requirements as the medicinal product already authorised in Switzerland, in particular in regard to the labelling and the medical information mentioned in Article 11;

b.

if the other person responsible for placing the medicinal product on the market can continue to guarantee that all the authorised medicinal products that he distributes fulfil the same requirements of safety and quality as those of the first applicant.

³ ...⁵⁷