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Jurisdiction(s):
United Kingdom
Key definition
Marketing Authorisation definition

What does Marketing Authorisation mean? Marketing authorisation is, in practice, the medicines regulator’s permission to place a medicinal product on the market. It specifies the authorised indications (medical conditions), patient population and dosage, and sets any conditions binding on the marketing authorisation holder (MAH). It is the legal basis for supply and promotion and underpins the Summary of Product Characteristics (SmPC), patient information leaflet and labelling. Use outside it is “off-label”. It is a statutory concept: in the UK under the Human Medicines Regulations 2012, and in Ireland under Directive 2001/83/EC and Regulation (EC) No 726/2004. In Great Britain, the MHRA grants national marketing...

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EU life sciences litigation and regulatory case tracker: key CJEU, General Court, EPO and UPC rulings on SPCs, medicines, devices, borderline products, trade marks and access to documents

Practice notes
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This Practice Note is designed to monitor the progress of EU cases relevant to the life sciences industry. For earlier life sciences materials, see Practice Note: Life sciences tracker [Archived]...

Judgments-Supplementary protection certificates

For archived supplementary protection certificate (SPC) judgments, see Practice Note: Life sciences tracker [Archived]-Judgments-Supplementary protection certificates...

Court of Justice of the European Union

What's happening? When? Find out more

  • Teva BV and Teva Finland Oy v Merck Sharp & Dohme LLC; Merck Sharp & Dohme LLC v Clonmel Healthcare Limited - Joined Cases C-119/22 and C-149/22
    • 19 December 2024: preliminary ruling of the Court of Justice (Third Chamber) issued.
    • 6 June 2024: Opinion of the Advocate General (AG).
    • 21 February 2022: reference made to the Court of Justice by the Supreme Court of Ireland.
    • 17 February 2022: reference made to the Court of Justice by the Supreme Court of Finland.

Requirements for obtaining an SPC for medicinal products-combination product-meanings of ‘product protected by a basic patent in force’ (Article 3(a)) and ‘product that has not already been the subject of an SPC’ (Article 3(c)). This ruling examines the criteria under Article 3(a) and 3(c) of Regulation (EC) 469/2009...

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Web page updated on 29/05/2026

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