The European Medicines Agency (EMA) published on September 28, 2026 the Pharmacovigilance Risk Assessment Committee (PRAC) recommendations on signals adopted at its 31 August to 3 September 2026 meeting (EMA/PRAC/183502/2026), setting product-information updates and supplementary-information deadlines for nine active substances.
Marketing authorisation holders (MAHs) of oxacillin-containing products, fentanyl transdermal patches, TNF inhibitors (AbbVie, UCB, Pfizer, Janssen-Cilag), gefitinib (AstraZeneca), anakinra (Swedish Orphan Biovitrum) and deucravacitinib (Bristol-Myers Squibb) must submit the required EMA variations and supplementary information by their PRAC-set deadlines, the earliest on November 3, 2026, or face regulatory action by national competent authorities and EMA for breaching Article 16(3) of Regulation 726/2004 and Article 23(3) of Directive 2001/83/EC.
What did the PRAC decide, and what must change?
The package (EMA/PRAC/183502/2026) contains one binding product-information variation and eight supplementary-information or PSUR requests. The variation concerns oxacillin: MAHs must add a Drug reaction with eosinophilia and systemic symptoms (DRESS) warning to SmPC sections 4.4 and 4.8 and to the package leaflet, flagging a potentially life-threatening cutaneous reaction and contraindicating re-exposure. The eight remaining signals require MAHs either to submit supplementary information assessing the signal or to cover it in the next Periodic Safety Update Report (PSUR).
For centrally authorised products (CAPs), the PRAC recommendations for product-information update were endorsed by the Committee for Medicinal Products for Human Use (CHMP) at its 14 to 17 September 2026 plenary, and the corresponding variations will be assessed by the CHMP. For nationally authorised products (NAPs), the National Competent Authorities (NCAs) of the Member States oversee adherence. Translations of the new product information in all official EU languages are available to MAHs on the EMA website.
Who has to act, and by when?
Each signal carries its own submission deadline. The earliest, November 3, 2026, applies to the anakinra and gefitinib supplementary-information requests; the oxacillin variation is due within two months of publication, by November 28, 2026.
| Active substance | Signal (EPITT) | Action | Deadline | MAH(s) |
|---|---|---|---|---|
| Oxacillin | DRESS (20223) | Variation: SmPC and leaflet update | November 28, 2026 | MAHs of oxacillin products |
| Anakinra | Fulminant hepatitis (20308) | Supplementary information | November 3, 2026 | Swedish Orphan Biovitrum |
| Gefitinib | Pulmonary alveolar haemorrhage (20307) | Supplementary information | November 3, 2026 | AstraZeneca |
| Adalimumab, certolizumab, etanercept, golimumab, infliximab | IgA nephropathy (18649) | Supplementary information | November 11, 2026 | AbbVie, UCB, Pfizer, Janssen-Cilag |
| Deucravacitinib | Pemphigoid (20304) | Assess in next PSUR | November 17, 2026 | Bristol-Myers Squibb |
| Fentanyl (transdermal patches) | Accidental exposure (17778) | Supplementary information | January 13, 2027 | MAHs of fentanyl patches |
| Acitretin | Erectile dysfunction (20310) | Assess in next PSUR | January 20, 2027 | MAHs of acitretin products |
| Lazertinib | Colitis (20296) | Assess in next PSUR | January 29, 2027 | Janssen-Cilag |
| Idarucizumab | Disseminated intravascular coagulation (20297) | Assess in next PSUR | January 13, 2028 | Boehringer Ingelheim |
Separately, the PRAC reviewed a meningioma signal for progestogens but recommended no action at this stage.
What must MAHs submit, and how?
MAHs of CAPs handle variations according to established EMA procedures and the published EMA guidance; variations for NAPs are handled at national level under each Member State's provisions. The PRAC timeline for submission following signal assessment applies to both innovator and generic medicinal products unless otherwise specified. Procedural questions on submission requirements and contact points are covered in the EMA Questions and Answers on signal management, and the relevant EPITT reference number must be used in all communication.
For supplementary-information requests, the MAH must assess the signal and submit its conclusions by the date set in the recommendation. For PSUR-assessment items, the signal must be addressed in the next PSUR due on the stated date.
What happens if MAHs miss the deadlines?
Article 16(3) of Regulation (EC) No 726/2004 and Article 23(3) of Directive 2001/83/EC require MAHs to keep their product information up to date with current scientific knowledge, including the conclusions and recommendations published on the EMA website. Non-compliance risks regulatory action by the NCAs and EMA, ranging from a request for corrective action to variation enforcement and, for NAPs, national supervisory measures. Continuous, per-jurisdiction monitoring of EMA pharmacovigilance outputs surfaces these signal recommendations the moment they publish, before a missed deadline compounds into enforcement.
- Confirm whether your portfolio includes any of the nine affected substances.
- Map each product to its EPITT reference and submission deadline.
- Brief pharmacovigilance and regulatory affairs to prepare the submission ahead of the November 3, 2026 deadline.
