Update on Plans for Ending Safety Features Use and Learn in Ireland on Phased Basis from 2nd March 2020

07th February 2020

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 2^nd 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: 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.

The Safety Features Oversight Group comprises the Irish Medicines Verification Organisation (IMVO), Department of Health, Health Products Regulatory Authority (HPRA), Pharmaceutical Society of Ireland (PSI), Health Service Executive (HSE) and Private Hospitals Association (PHA).
For the purposes of this communication, a ‘primary wholesaler’ is considered to be the wholesaler that first receives stock into Ireland from a wholesaler or manufacturer in another EU member state and supplies it to the Irish market, or the wholesaler that receives stock directly from an Irish manufacturer and supplies it to the Irish market.
i.e. all wholesale distribution authorisation (WDA) holders, including pharmacies that carry out wholesaling activities.

Further information:

IMVO

Website: www.imvo.ie

Queries re alerts: alert.support@imvo.ie

Queries re end-user registration/connection to national system: registration@imvo.ie

Tel: +353 1 5715320

HPRA

Website: https://www.hpra.ie

HPRA website – General FMD information

HPRA website – Report an issue

Queries: compliance@hpra.ie

Tel: +353 1 6764971