EMA issues guidance on submitting ePI ahead of upcoming requirement
The European Medicines Agency (EMA) has published a guidance on how companies submitting marketing authorization applications (MAA) should provide electronic product information (ePI) for products under the EU's centrally authorized review process. The agency noted that submitting ePI is voluntary until the general pharmaceutical legislation fully goes into effect.
"During the voluntary phase, ePI can be submitted in English and submission of any EU language translations (including Icelandic and Norwegian) of ePI is optional," said EMA. "Submission of ePI in all languages is expected to become mandatory in future.
"Once an ePI has been published, it is the responsibility and obligation of the applicant to ensure that throughout subsequent procedures the ePI (and accompanying translations if included) is kept aligned with the latest approved version of the product information (PI)," the agency added.
EMA published its guidance for submitting ePI on 1 September, noting that it only takes into account Annex I (summary of product characteristics), Annex II, and Annexes IIIA (labeling) and IIIB. The agency highlighted that the guidance does not address other annexes to the European Commission (EC) Decision and noted that applicants are still required to submit product information annexes, such as summary of product characteristics (SmPC), annex II, labeling, and package leaflet, in an electronic Common Technical Document (eCTD).
The guidance includes a table that guides applicants on when to submit ePI to the Product Lifecycle Management (PLM) portal. It states that MAA applicants should submit their ePI at the same time as their procedure application, and, if submitting a change, at the same time as the final PI translations. It also notes that for Type IA/IAIN, Type IB, Article 61(3) submissions, submissions for transfer of marketing authorizations, and all other post-authorization procedures, applicants should submit ePI at the same time as their submission of procedure application.
EMA said that it considers an ePI as being submitted when the ePI associated with the procedure is in Submitted status in the PLM portal, when its content are in line with the content of the (final) Annex I, II, IIIA and IIIB submitted for the corresponding regulatory procedures, and the known procedure number has been input in the procedure number field of the ePI in the PLM portal. The agency also emphasized that only MAAs can be in Draft status on the PLM portal, all other procedures and timepoints must be in Submitted status.
In addition to outlining the general principles and publication considerations for ePIs, the guidance addresses considerations for creating an ePI for the first time and for updating an ePI. It also outlines what to do in different scenarios, such as when a product's marketing authorization is suspended or transferred to another entity.
If the MAA is transferred to another entity, the guidance outlines several steps that the transferor and transferee must follow in a table, culminating in the transferee opening a ticket in the EMA Service Desk requesting that the agency transfer the EPI to its custody.
"The Agency will publish the ePI associated with the transferee after the issue of the EC Decision granting the transfer," said EMA.
The guidance states that the ePI owner must move the ePI to Deactivated status within 15 working days of being notified by EMA that its MAA or MA has been withdrawn.
"The applicant shall move all ePIs that are in Submitted status to Deactivated status, as soon as the withdrawal has been notified to the Agency (within 15 working days)," said EMA. "If an ePI has already been published for the medicine, the ePI will remain published in the ePI repository and available via the API.
"If, in addition, there are also previous versions of the ePI in Archived status, these versions will remain as-is," the agency added.
Similarly, MAA applicants are required to change the status of their ePI to Deactivated within 15 days of getting an unfavorable opinion from EMA but can remain in any status if the applicant requests a re-examination of the application until a final outcome is given.
"If the applicant has created one/several ePIs for the refused procedure, (i.e. the ePIs are in Submitted status), the applicant must move all related ePIs out of Submitted status (to Draft or Deactivated), within 15 working days after the negative CHMP opinion or notification has been issued," said EMA. "If the applicant requests a re-examination, the ePI(s) can remain in any status pending the final outcome of the procedure.
"If the final outcome is unfavourable: within 15 working days after the unfavourable opinion, the applicant must change the status of the ePI(s) to Deactivated," the agency added. "The applicant will also ensure that the number of the refused procedure will not be included in the procedure number field of other ePIs related to other ongoing or recently finalised procedures."
