News Category: Regulatory news
The EU Commission and EMA have today published an updated list of questions and answers related to the United Kingdom's withdrawal from the EU. The focus of this Q&A is on the regulation of medicinal products for human and veterinary use within the framework of the centralised procedure.
Significantly, the latest Q&A confirms that dual UK and Irish labels are acceptable where the labels meet the requirements of the Directive and reflect the SPC in Ireland. See Question 24 for further details.
The HPRA will continue to provide Brexit updates and guidance through the Latest Information page of our website.
Industry stakeholders wishing to discuss any aspect of their planning related to the UK’s withdrawal from the EU can submit their queries to the relevant e-mail address below. In particular, we encourage companies to engage with the HPRA at the first opportunity if they believe that Brexit may impact on their ability to supply a health product to the Irish market.
Human Medicines / Compliance: article50changes@hpra.ie
Veterinary Medicines: vetinfo@hpra.ie
Medical Devices: devices@hpra.ie