GLP-1 drugs and peptides in European Union

Medicines need a marketing authorisation before they are placed on the market (Directive 2001/83/EC, Art. 6). The centralised procedure is compulsory for medicines made by biotechnology (such as recombinant DNA technology), for new active substances for diabetes and certain other listed diseases, and for orphan medicines; other new active substances may opt in (Regulation (EC) No 726/2004, Art. 3 and Annex). In that procedure EMA's CHMP gives an opinion and the European Commission issues a decision that applies in all member states (register: Union Register). Directive 2001/83/EC excludes magistral and officinal pharmacy preparations (Art. 3(1)-(2)) and lets member states allow supply of unauthorised medicines to fill special needs on a named-patient basis (Art. 5(1)). These exceptions are implemented nationally, and there is no EU-level equivalent of the US shortage-based compounding regime. A product presented as treating disease, or able to change physiological functions pharmacologically, is a medicinal product (Art. 1(2)). Prescription medicines may be sold online to the public only where national law allows it and only by authorised sellers (Art. 85c), and EU-registered online pharmacies show the common EU logo. Member states set pricing and reimbursement. Examples: Germany excludes weight-loss medicines from statutory health insurance (§ 34(1) SGB V); the G-BA added Wegovy to Annex II (lifestyle medicines) of its Pharmaceutical Directive on 21 March 2024, and the current Annex II (in force 20 August 2025) lists Saxenda, Wegovy and Mounjaro when used for weight reduction. Italy classes Wegovy, Saxenda and Mounjaro for obesity as class C, paid by the patient. France has reimbursed Wegovy and Mounjaro at 65% since 15 June 2026 for BMI of 40 and above, or 35 and above with a listed comorbidity, with initial prescription restricted to specialist obesity settings (arrêtés of 23 May 2026, amended 10 June 2026). Recent enforcement and warnings: EMA and the Heads of Medicines Agencies warned on 3 September 2025 of a sharp rise in illegal medicines, including falsified semaglutide, liraglutide and tirzepatide, sold via fraudulent websites and social media, and EMA warned on 18 October 2023 about falsified Ozempic pens. Enforcement against individual sellers is national and was not surveyed one country at a time. The EU pharmaceutical legislation reform (political agreement reported by the Commission in December 2025) is intended to replace Directive 2001/83/EC; its adoption status, advertising and other provisions were not assessed here.