The Health Products Regulatory Authority (HPRA) is transitioning to a new human medicines electronic workflow system which will form the basis of the process for assessing and issuing the marketing authorisations for medicinal products for human use. The HPRA anticipates that the ‘go-live’ implementation of the new system will take effect from 7th August 2018.
Changes that will affect marketing authorisation holders (MAHs) include:
- Case Reference Number (CRN) – CRNs were previously displayed as seven digits but these will now be alpha numerical for any new cases, for example CRN00011X. Any closed or ongoing cases using the old CRN will still be identifiable.
- Product Specific Details (PSD) – product specific information will no longer be part of the product licence document. When the electronic workflow system is implemented, the product licence document will only consist of the licence cover page and the summary of product characteristics (SPC). Information previously detailed in the PSD will be logged on the HPRA database and remain a registered part of the product marketing authorisation.
- Digital communication – all new cases will have a designated email address, for example [casenumber]@case.hpra.ie. HPRA advises MAHs to consult with their information technology (IT) departments to ensure that these emails are not blocked. The European e-mail boxes will still be used where applicable.
To read more about the HPRA human medicines electronic workflow system, please click here.