{"id":515,"date":"2026-08-31T18:13:46","date_gmt":"2026-08-31T16:13:46","guid":{"rendered":"https:\/\/www.pqra.gr\/the-sunset-clause-and-renewals-two-deadlines-that-quietly-end-authorisations\/"},"modified":"2026-08-31T18:13:55","modified_gmt":"2026-08-31T16:13:55","slug":"the-sunset-clause-and-renewals-two-deadlines-that-quietly-end-authorisations","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-sunset-clause-and-renewals-two-deadlines-that-quietly-end-authorisations\/","title":{"rendered":"The Sunset Clause and Renewals: Two Deadlines That Quietly End Authorisations"},"content":{"rendered":"

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 \u2014 three years without a product on the market and the authorisation simply ceases to be valid.<\/strong><\/p>\n\n

The renewal: five years, then normally forever<\/h2>\n\n

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 \u2014 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.<\/p>\n\n

The submission deadline is at least nine months before expiry<\/strong>. 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.<\/p>\n\n

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.<\/p>\n\n

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 \u2014 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.<\/p>\n\n

The sunset clause: three years of silence<\/h2>\n\n

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 \u2014 and that an authorised product previously on the market but absent for three consecutive years likewise ceases to be valid.<\/p>\n\n

Two details are routinely misunderstood:<\/p>\n\n