PLM Portal: EMA product lifecycle management portal

The Product Lifecycle Management (PLM) Portal is the European Medicines Agency's platform for the data and documents that accompany a centrally authorised product through its life. It hosts the web-based electronic application forms (eAF) for marketing authorisation applications and variations, which replaced the earlier interactive PDF forms and draw their organisation, substance and referential data from the SPOR services, and the eSubmission function through which eCTD sequences are delivered to EMA, replacing the eSubmission Gateway and Web Client. Users sign in with an EMA account, and their organisation must be registered in the Organisation Management Service before they can act for it. EMA has made the web-based forms mandatory for centrally authorised products in stages, so the portal is now the normal front door to the Agency.

The portal matters because it links the dossier to structured product data. A variation form filled in through the PLM Portal records the change against the product as EMA holds it, which supports the ISO IDMP data model that the EU is implementing through the Product Management Service. Each form has a validation step that checks required fields and the consistency of the selected product, procedure type and change categories before the form can be locked and exported as the PDF that goes into the eCTD. For national procedures the picture is mixed: the web-based forms can be used for some national submissions, while the dossier itself still travels through CESP or national portals, and the Variations Regulation changes planned under the pharma package push further in this direction.

What goes wrong: a user tries to create a form before their organisation and role are set up in OMS, which can take days; the product selected in the form is the wrong presentation or an outdated version of the product data; the change categories chosen in the eAF do not match the cover letter and the classification guideline; the locked form is edited by hand in PDF, so the data and the document disagree; and a submission is sent through the old gateway address after the switch-over date and is not received. Because EMA validation starts from the form, a defective form delays the start of the procedure even when the dossier is sound.

Under the new pharma package (not yet in force), variation applications for national as well as centrally authorised products must be made electronically in EMA formats, which points to the PLM Portal forms becoming the single route; see variations changes.