Suspension and revocation: authority action pausing or ending a marketing authorisation
Suspension and revocation are the measures an authority takes under Article 116 of Directive 2001/83/EC to pause or end a marketing authorisation.
Article 116 of Directive 2001/83/EC requires a competent authority to suspend, revoke or vary a marketing authorisation where it takes the view that the product is harmful, lacks therapeutic efficacy, has a benefit-risk balance that is not favourable, or does not have the qualitative and quantitative composition declared. It may also act where the particulars in the application were incorrect or have not been amended, where the conditions attached to the authorisation have not been met, or where the required controls have not been carried out. Article 117 adds the parallel power to prohibit supply and order a product withdrawn from the market. For centrally authorised products the equivalent powers sit in Article 20 of Regulation (EC) No 726/2004, exercised by the Commission after a CHMP opinion, with Member States able to suspend use on their territory in urgent cases.
Suspension is the reversible option: the authorisation remains on the register but the product cannot be placed on the market until the authority lifts the measure, usually once the holder has resolved the concern or supplied the missing data. Revocation ends the authorisation outright, and a new application is needed to return to the market. In practice both are preceded by a formal hearing of the holder, and safety-driven cases run through a PRAC recommendation and a referral or a PSUSA before the national or Commission decision is taken. A holder can also ask for suspension itself, for example while a manufacturing problem is fixed, which is distinct from a voluntary withdrawal of the authorisation.
What goes wrong: holders treat a suspension as a pause in obligations, when pharmacovigilance, PSUR and variation duties continue; they miss that a suspension in one Member State after an MRP or DCP usually has to be mirrored elsewhere once the CMDh or CHMP has taken a position; and they forget that a suspended product still counts against the three-year clock of the sunset clause unless the authority grants an exemption. Groups also overlook the Article 123 obligation to tell the authority, with reasons, about any action to suspend marketing or withdraw a product on safety grounds, including actions taken in third countries.
Under the new pharma package (not yet in force), the grounds on which authorities can suspend, revoke or vary an authorisation are restated in Article 198 of the agreed directive, alongside authorisations that are valid for an unlimited period by default; see MA validity changes.
Timing
No fixed statutory clock applies to a national suspension or revocation; the authority must hear the holder first unless the measure is urgent, and it notifies the Commission and other Member States of its decision. Where the case runs through an EU procedure, the referral timetable governs: a PRAC recommendation, a CHMP opinion or CMDh position, and a Commission decision that Member States implement within the deadline it sets, often 30 days for national authorisations. Suspensions are typically reviewed when the holder submits evidence that the concern is resolved.
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Portfolio teams catch suspension and revocation decisions the day they are published with Alerts, which watches EMA and national authority notices.
Related terms
- 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.
- Referral: EU-level assessment of a disputed or safety issueA referral is an EU procedure that resolves a scientific or regulatory issue about a medicine, or a class of medicines, in a single EU-level assessment.
- Sunset clause: lapse of an unused marketing authorisationThe 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.
- PRAC: Pharmacovigilance Risk Assessment CommitteeThe PRAC is the EMA committee that assesses the safety of human medicines in the EU, from risk management plans and PSURs to signals and safety referrals.
- 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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