Following discussions at a national level between the Department of Health, the Health Products Regulatory Authority (HPRA), the Pharmaceutical Society of Ireland (PSI), the HSE and Private Hospitals Association (PHA) stakeholder representatives and IMVO, it has been decided to adopt a pragmatic approach to the implementation of the Delegated Regulation (and the associated statutory instrument) after the go live date, to ensure the continuity of safe supply of medicines to patients while all parties gain a better understanding of the new system. This means that:
National legislation including the provisions of Article 23 of the Delegated Regulation will be introduced, however, the offences provided for in the Regulations will not be commenced for a period of time to let the new system bed in.
During this period, the alerts generated will be analysed by the Department of Health, IMVO, HPRA, PSI, HSE and the private hospital pharmacies to determine why they are occurring and develop appropriate protocols for their resolution. Manufacturers (and marketing authorisation holders (MAHs) will also be involved in the investigation of alerts generated against their products. The system will be reviewed again in three months’ time. This approach will ensure that medicines continue to be provided to patients without delay and also ensure that all stakeholders, manufacturers, wholesalers, pharmacists and other healthcare professionals work to build confidence in operating the new safety system.
Formal notification of this agreed national approach has been issued today to pharmacists, wholesalers, MAHs and manufacturers by the PSI and the HPRA. IMVO is very appreciative of the careful consideration given to the matter by the authorities in Ireland and we will continue to work closely with them over the coming months to maximise the learnings about the system during this ‘use and learn’ period.