Sunset clause: lapse of an unused marketing authorisation
The sunset clause ends a marketing authorisation if the product is not marketed within three years of grant, or later leaves the market for three years.
It is set out in Article 24(4) to (6) of Directive 2001/83/EC and Article 14(4) to (6) of Regulation (EC) No 726/2004. For national, MRP and DCP products it applies per Member State, so a product can lapse in one country while remaining valid elsewhere. Exemptions are possible in exceptional circumstances and on public health grounds.
What goes wrong: dormant licences kept for a later launch are lost because nobody tracked when the product left the market, and marketing notifications are not filed in countries that require them.
The text the Council adopted in September 2026 (not yet in force) has no sunset clause, and authorisations become valid for an unlimited period by default; see MA validity changes.
Used in
Atlas can track marketing status and lapse dates on one licence timeline.
Related terms
- MAH transfer: transfer of a marketing authorisation to a new holderAn MAH transfer moves a marketing authorisation from one legal entity to another, making the new company legally responsible for the product.
- PSUR: periodic safety update reportA periodic safety update report (PSUR) is a holder's periodic benefit-risk evaluation of a medicine, due at intervals set by the EURD list or the MA.
- MA withdrawal: voluntary withdrawal of a marketing authorisationAn MA withdrawal is the holder's decision to give up a marketing authorisation, notified to the authority with its reasons and any supply consequences.
- Renewal: five-year re-evaluation of a marketing authorisationA renewal is the re-evaluation of a marketing authorisation's benefit-risk balance after its first five years, after which it is normally unlimited.
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