¹ Ready-to-use medicinal products and veterinary medicinal products intended for the manufacture of medicinal foodstuffs (premixed medicinal products) may be placed on the market only if authorised by the Agency; the foregoing is without prejudice to international agreements on the recognition of marketing authorisations.

² The following shall be exempt from authorisation:

a.³²

medicinal products prepared according to a doctor’s prescription by a public pharmacy or a hospital pharmacy, or under mandate to the latter by another establishment holding a manufacturing licence, and for a given person or group of persons or for a given animal or livestock (magistral formula); on the basis of a prescription, the medicinal product may be manufactured by the public pharmacy or the hospital pharmacy as required or on a small industrial scale but may only be dispensed on a doctor’s prescription;

b.³³

medicinal products prepared as required or on a small industrial scale by a public pharmacy, a hospital pharmacy, a drugstore or by another establishment holding a manufacturing licence, conforming to a special monograph of the Pharmacopoeia or another pharmacopoeia or a formulary recognised by the Agency, and which are supplied to their own customers (officinal formula);

c.³⁴

non-prescription medicinal products prepared as required or on a small industrial scale by a public pharmacy, a hospital pharmacy, a drugstore or by another establishment holding a manufacturing licence, within the limits of the establishment’s right to dispense in compliance with Article 25, according to its own formula or a formula published in the specialised literature, which are intended for dispensing to the establishment's own customers;

c^bis.³⁵ medicinal products for which it is proven that there is no authorised or available alternative medicinal product that is applicable and equivalent and which are manufactured in a hospital pharmacy in accordance with the hospital’s own pharmaceuticals list, on a small industrial scale, and are intended for dispensing to its own customers;

d.

medicinal products intended for clinical trials;

e.

medicinal products which cannot be standardised;

f.³⁶

medicinal products that were authorised in a canton on 1 January 2002 and which were still on the market when the Amendment of 18 March 2016 came into force; they must be labelled accordingly and may only be placed on the market in the canton concerned and only supplied by persons entitled to supply medicinal products under this Act.

^2bis An establishment with a manufacturing licence may be commissioned to manufacture medicinal products (contract manufacture) in accordance with paragraph 2 a–c^bis.³⁷

^2ter Companies holding a manufacturing licence issued by the Agency may manufacture a complementary medicine for which no alternative and equivalent medicinal product is demonstrably available or authorised, even without a contract manufacturing order in accordance with paragraph 2^bis, and market them to companies which are authorised to manufacture these products in accordance with paragraph 2 letters a, b and c. A company may not manufacture more than 100 packages of such a medicinal product with a maximum total of 3,000 daily doses; in the case of homeopathic and anthroposophic medicinal products, this restriction applies to each dilution individually.³⁸

^2quater The Federal Council shall lay down the qualitative and quantitative criteria for the medicinal products manufactured in accordance with paragraphs 2 letters a–c^bis and 2^bis, and the qualitative criteria for the medicinal products manufactured in accordance with paragraph 2^ter.³⁹

³ The Federal Council may make provision for a requirement of authorisation for the production or manufacturing process used in making medicinal products which cannot be standardised.

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