European Medicines Agency (EMA) with the European Commission; national competent authorities in each member state
Is Melanotan II legal in European Union?
Not approvedNo EU marketing authorisation; not listed in EMA or Union Register data
Not approved as a medicine here.
Melanotan II does not appear in the EMA medicines dataset or the Union Register. Afamelanotide (Scenesse) is authorised in the EU, but it is a different molecule, approved only for a rare light-sensitivity disease (erythropoietic protoporphyria). Under Article 6 of Directive 2001/83/EC, no medicine may be placed on the market without a marketing authorisation. Melanotan II products for tanning are therefore unauthorised medicines. National enforcement varies and was not surveyed.
Last verified 2026-09-29 · how we verify
Melanotan II elsewhere
Sources (3)
- 01EMA medicines data (JSON report): human and veterinary medicines, with authorisation statusEuropean Medicines Agency · 2026-09-29 · accessed 2026-09-29
- 02Union Register of medicinal products for human useEuropean Commission · 2026-09-29 · accessed 2026-09-29
- 03Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)European Union (EUR-Lex) · 2025-01-01 · accessed 2026-09-29