Update on Plans for Ending Safety Features Use and Learn in Ireland on a Phased Basis 

Following on from previous communications about plans to end the use and learn period on a phased basis, the Safety Features Oversight Group1 agreed that this will be done on a phased basis. The first phase began on 2 March 2020. 

On 30 April 2020, changes to the timeline were announced in light of the COVID-19 pandemic. 

Update: 30 April 2020 

The Safety Features Oversight Group has been reviewing plans to end the FMD use and learn period on a phased basis in light of the COVID-19 pandemic. The Group recognises that this crisis has placed considerable strain on all parties involved in the medicines supply chain in Ireland – pharmacies, hospitals and wholesalers as well as manufacturers, MAHs and parallel importers/distributors – and acknowledges the excellent work being done by everyone to maintain the supply of medicines, while ensuring staff and public safety. The obligation to move towards full compliance with the Falsified Medicines Directive (FMD) remains, however, given the unique circumstances in which we find ourselves, it has been decided to delay plans previously notified to end the use and learn period for wholesalers in May and for pharmacies and hospitals in September.

IMVO is operating as normal and has been closely monitoring FMD activity on the ground over the last few weeks as well as liaising with other national medicines verification organisations to see how they are being impacted by COVID-19. IMVO is also continuing to work in the background to reduce the number of avoidable alerts due to manufacturer and system issues and to prepare for the end of use and learn.

The Safety Features Oversight Group will continue to closely monitor the situation over the next few weeks and new dates for ending the use and learn period will be notified in due course. In the meantime, the advice is as follows:

  1. If you have any queries about your FMD obligations, please contact the PSI (Retail Pharmacy Businesses), HSE FMD project team (public hospitals), HPRA (wholesalers, MAHs, manufacturers, parallel importers, parallel distributors).

  2. Parallel importers and parallel distributors should continue to comply with the guidance issued to them by the HPRA on 7 February 2020.

  3. Please contact IMVO if you have queries about your connection to the national system (including new registrations, login queries, change of FMD software provider) or want to follow up on specific alerts or scanning issues.

  4. If at any stage you have grounds for believing that a pack has been interfered with or could be falsified, please report this to the HPRA, by email to qualitydefects@hpra.ie or using the HPRA’s online reporting system (select the link called ‘Report an issue’, then ‘Medicine Quality Issue / Defect’).

Timeline for Ending the Use and Learn Period

Phase

Date

What This Means

Phase 1:

Use & learn ends for products that are parallel imported and parallel distributed 

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.

Phase 2:

Use & learn ends for all wholesalers2

To be confirmed

  • 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

To be confirmed

  • 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.

1. 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).
2. Relates to all wholesale distribution authorisation (WDA) holders, including pharmacies that carry out wholesaling activities.
 

Further Information 


IMVO

Website

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:


Queries: compliance@hpra.ie

Tel: +353 1 6764971


PSI

Website 

Queries: info@psi.ie

Tel: +353 1 2184000

 

HSE

Queries re FMD implementation in public hospitals and clinics: FMD.support@hse.ie


EMVO

(for manufacturer queries relating to EU Hub & uploading of data)

Website 

Support queries: helpdesk@emvo-medicines.eu

Tel: +32 2 657 00 08