Treating a Substance as an Active Ingredient.

Treating a Substance as an Active Ingredient.

Journal article

1 online resource (pages 1074–1075)

Regulation No. 469/2009 concerning the supplementary protection certificate for medicinal products, Art. 1(b) – Trastuzumab Headnotes by the Editorial Office 1. The assessment of the specific pharmacological, immunological or metabolic action which is covered by the therapeutic indications of a substance must be made with a view to the contents of the marketing authorisation. 2. When the marketing authorisation does not categorise a substance as an ‘active ingredient’, there is a rebuttable presumption that this substance has no pharmacological, immunological or metabolic action of its own covered by the therapeutic indications of this marketing authorisation. Court of Cassation (Cour de cassation), judgment of 1 February 2023 – 101 FP-B on appeal D 21-15.221

Crossref

GRUR International, 2632-8550 ; 72, 11, 2023.

[Oxford, England] : Oxford University Press (OUP), 2023

eng

https://academic.oup.com/grurint/article/72/3/231/6998505

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