Following on from previous communications about plans to end the use and learn period on a phased basis, the Safety Features Oversight Group1 has now agreed that this will be done in the following phases starting from 2nd March 2020:
|Phase||Date||What this means|
|Phase 1 |
Use & learn ends for products that are parallel imported and parallel distributed and products handled by primary wholesalers2 (certain activities only)
|Confirmed date – Monday 2nd March 2020||Products that are parallel imported and parallel distributed: |
A manufacturer who carries out repackaging operations on products intended for the Irish market must ensure that alerts generated when they verify and/or decommission the originator packs are resolved.
The cause of any alerts received during the upload of data for the new barcodes must be investigated and resolved before the packs can be supplied.
The HPRA is writing to all parallel importers and parallel distributors, who are active in Ireland, with detailed guidance.
Primary wholesalers are requested to scan one pack per pallet of incoming goods and, if any alerts are generated, quarantine the incoming packs from that pallet and request that the marketing authorisation holder (MAH) investigate and correct any data errors. The HPRA is writing to the relevant wholesalers with detailed guidance.
|Phase 2 |
Use & learn ends for all wholesalers3
|Planned for May 2020 – exact date to be notified in due course||Use and learn will end for all wholesalers.|
All alerts generated as a result of their scanning activity must be investigated and resolved before the packs can be supplied onwards. The HPRA and IMVO will carry out targeted consultation with the relevant parties.
|Phase 3 |
Use & learn ends for pharmacies, hospitals and all others who supply medicines to the public
|Planned for September 2020 – exact date to be notified in due course||Use and learn will end for all entities who supply medicines to the public including pharmacies and hospitals |
All alerts generated as a result of their scanning activity must be investigated and resolved before the packs can be supplied.
The HPRA, PSI and IMVO will carry out targeted consultation with relevant parties.
Queries re alerts: email@example.com
Queries re end-user registration/connection to national system: firstname.lastname@example.org
Tel: +353 1 5715320
Tel: +353 1 6764971
Tel: +353 1 2184000
Queries re FMD implementation in public hospitals and clinics: FMD.email@example.com
(for manufacturer queries relating to EU Hub & uploading of data)
Support queries: firstname.lastname@example.org
Tel: +32 2 657 00 08