Most marketing authorisations are lost through inattention rather than refusal. Two provisions do the work: the renewal, which requires a positive act nine months before expiry, and the sunset clause, which requires no act at all — three years without a product on the market and the authorisation simply ceases to be valid.
The renewal: five years, then normally forever
Under Article 24 of Directive 2001/83/EC and Article 14 of Regulation (EC) No 726/2004, a marketing authorisation is valid for five years. It may then be renewed on the basis of a re-evaluation of the benefit-risk balance, and once renewed it is valid for an unlimited period — unless the competent authority (or, for centrally authorised products, the Commission) decides on justified pharmacovigilance grounds, including exposure of an insufficient number of patients, to require one additional five-year renewal.
The submission deadline is at least nine months before expiry. This changed with Directive 2010/84/EU; older codifications still say six months, so check the source you are working from. EMA will not accept a renewal submitted more than two months early, and there is no fee for a centralised renewal.
Two exceptions matter. Authorisations granted under exceptional circumstances remain on a five-year cycle. Conditional marketing authorisations are valid for one year and renewed annually, with the application due at least six months before expiry.
In the mutual recognition and decentralised procedures, CMDh’s best practice guide sets a 30-day standard renewal with no clock stop, expanding to a 90-day procedure where full documentation is requested. By default only a cover letter and the renewal application form are required — the dossier is expected to have been kept current through variations, and no changes to the authorisation particulars can be made during a standard renewal.
The sunset clause: three years of silence
Article 24(4) and (5) of the Directive, and Article 14(4) and (5) of the Regulation, provide that an authorisation not followed by actual placing on the market within three years of grant ceases to be valid — and that an authorised product previously on the market but absent for three consecutive years likewise ceases to be valid.
Two details are routinely misunderstood:
- The test differs by procedure. For centrally authorised products, the authorisation survives if at least one presentation is on the market in at least one EU/EEA Member State. For nationally authorised products, including MRP and DCP, the test is the market of the authorising Member State — so the same product can lapse in Greece while surviving in Germany.
- “Placed on the market” means released into the distribution chain, not sold to a patient. The clock runs from the last date of release, and it restarts if the product returns to the market.
For generics, hybrids and biosimilars, the three years run from the end of the reference product’s marketing protection, not from the date of grant. Exemptions are available in exceptional circumstances on public health grounds, granted by the Commission for centrally authorised products and by the national authority otherwise, and must be duly justified.
How Greece applies it
EOF applies the sunset clause under Articles 39 and 40 of Ministerial Decision Δ.ΥΓ3α/Γ.Π. 32221/2013. Its April 2026 circular sets out the mechanics: EOF writes to holders with a list of their products which, on the sales data EOF holds, have not been marketed in any pack, form or strength for three consecutive years. Authorisations that fall within the provision are revoked automatically by a declaratory act of EOF. A dedicated Sunset Clause Committee reviews observations and exemption requests before the President decides. Centrally authorised products are outside EOF’s remit here — that is EMA’s competence.
The circular also states plainly that the clause applies irrespective of whether the product has been renamed or the holder has changed in the meantime.
What this means in practice
- Track a renewal date and a last-release date for every authorisation, in every market, not just the EU-level dates.
- Diarise the renewal at eleven months, not nine — the window for early submission is narrow.
- Treat a product you are holding dormant for strategic reasons as a live risk, and apply for an exemption before the third year, not after the letter arrives.
- Notify supply interruptions on time. In Greece the notice period is three months, longer than the two months the Directive requires.
How PQRA helps
We maintain renewal and sunset calendars across portfolios, prepare centralised and national renewal submissions, handle EOF correspondence and exemption requests under the Greek procedure, and audit dormant authorisations so that a product you intend to relaunch is still yours to relaunch.
Unsure which of your authorisations are exposed? Ask PQRA for a portfolio review.
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