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Art. 9 Federal Act of 15 December 2000 on Medicinal Products and Medical Devices (TPA) - Marketing authorisation
Legislator summary
AI generatedReady-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. The following shall be exempt from authorisation: a. {note: Amended by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 ( AS 2008 4873, 2010 4027; BBl 2007 2393).} 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. {note: Amended by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 ( AS 2008 4873, 2010 4027; BBl 2007 2393).} 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. {note: Amended by No 1 of the FA of 13 June 2008, in force since 1 Oct. 2010 ( AS 2008 4873, 2010 4027; BBl 2007 2393).} 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; [tab] c bis. {note: Inserted by No I of the FA of 13 June 2008, in force since 1 Oct. 2010 ( AS 2008 4873, 2010 4027; BBl 2007 2393).} 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. {note: Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2018 ( AS 2017 2745; BBl 2013 1).} 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. An establishment with a manufacturing licence may be commissioned to manufacture medicinal products (contract manufacture) in accordance with paragraph 2 a–c bis. {note: Inserted by No I of the FA of 13 June 2008 ( AS 2008 4873, 2010 4027; BBl 2007 2393). Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} 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. {note: Inserted by No I of the FA of 13 June 2008 ( AS 2008 4873, 2010 4027; BBl 2007 2393). Amended by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} 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. {note: Inserted by No I of the FA of 18 March 2016, in force since 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).} 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. ... {note: Repealed by No I of the FA of 18 March 2016, with effect from 1 Jan. 2019 ( AS 2017 2745, 2018 3575; BBl 2013 1).}
Art. 9 TPA · Marketing authorisation
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.
The following shall be exempt from authorisation: a. 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. 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. 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; [tab] c bis. 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. 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.
An establishment with a manufacturing licence may be commissioned to manufacture medicinal products (contract manufacture) in accordance with paragraph 2 a–c bis.
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.
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.
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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