News Category: Regulatory news
For the attention of Marketing Authorisation Holders,
The HPRA is pleased to announce that we are transitioning to a new human medicines electronic workflow system which underpins the process for assessing and issuing the marketing authorisations for medicinal products for human use. The new solution will introduce additional features which will support our functions and enhance our interaction with stakeholders. It is anticipated that the ‘go-live’ implementation of the new system will take effect in late August.
As a result, there will be some changes to the way in which we communicate with you regarding your application submission to the HPRA. We want you to be aware of these changes and ask that you read this notification carefully to help ensure the transition to our new system causes you as little disruption as possible.
Case Reference Number (CRN)
Previously CRNs were displayed as seven digits. These will now be alpha numerical for any new cases e.g. CRN00011X. The HPRA will still be able to identify any closed or ongoing cases using the old CRN.
Product Specific Details (PSD)
The product specific information will no longer form part of the product licence document. Previously the product licence document consisted of the licence cover page, PSD and Summary of Product Characteristics (SPC). In future, the product licence document will consist of the licence cover page and the SPC only. The information previously detailed in the PSD will be logged on the HPRA database and remain a registered part of the product marketing authorisation.
All cases on the new system will be assigned a dedicated e-mail address e.g. [CaseNumber]@case.hpra.ie. This will enable you to send the HPRA case-specific communications directly to the case and the allocated team. E-mail correspondence sent to you from the HPRA that is relevant to the case will come from this dedicated e-mail address. The European e-mail boxes will still be used where applicable.
Please consult with your IT departments to ensure that e-mails of this nature are not blocked in your organisation.
While the HPRA will endeavour to ensure that we adhere to all timelines and that service levels are maintained during and following the transition to the new system, we appreciate your understanding and patience during this transition phase. Finally, please contact us via email at email@example.com in the unlikely event that you find any inaccurate information arising from the transition to the new system.
Should you have any further questions on this update please send them to firstname.lastname@example.org