News Category: Regulatory news
A Notice to Stakeholders titled ‘Withdrawal of the United Kingdom and EU Rules for Medicinal Products for Human Use and Veterinary Medicinal Products’ (Rev 3, dated 13 March 2020), published by the European Commission and the European Medicines Agency states, ‘Article 41 of the Withdrawal Agreement provides that an existing and individually identifiable good lawfully placed on the market in the EU or the United Kingdom (UK) before the end of the transition period may be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its end user’.
This means that a medicine, which is certified by a Qualified Person and has been released in the United Kingdom (UK)* for sale or supply before 11 pm on 31 December, can be supplied to the Irish market after the transition period ends. The receiving site in Ireland, which must be appropriately authorised (e.g. an authorised manufacturer or wholesaler), must perform checks on all shipments of medicine received to which the provisions of Article 41 apply. The site must confirm that each batch of medicine met the following requirements before 11 pm on 31 December:
- Manufactured
- Certified by a Qualified Person for the EU or UK market
- Released for sale or supply to the EU or UK market
The receiving site must also confirm that the batch has been stored in appropriately authorised site(s) in the intervening period between the 31 December and the time of supply to the Irish market.
The onus is on the receiving site to obtain assurance, through documentary evidence, that the above requirements are met and that the medicine was placed on the market before the end of the transition period. Documentary evidence that would be considered acceptable is:
- A written statement from the Marketing Authorisation Holder (MAH), or the authorised manufacturer or a wholesaler supplying the batch,
- Reference to company internal systems (such as global Enterprise Resource Planning system) that demonstrates the above requirements have been met.
Evidence that a medicine was already in the supply chain before 11 pm on 31 December 2020, for example that the medicine was stored at an authorised wholesaler in the UK* before that date, would suffice as ownership could not have transferred to that wholesale site until all the above requirements had been met.
Other forms of evidence that provide objective confirmation that the batch was placed on the market before the end of the transition period may be acceptable.
The receiving site in Ireland should retain this evidence on file and have it available for inspection.
*In accordance with the Northern Ireland protocol, there will be no change to the existing regulatory requirements for the supply of batches of medicines, certified by a Qualified Person at a manufacturing site and released for sale or supply in Northern Ireland, to the Irish market.
This advice is without prejudice to customs requirements.
If there are specific queries, these can be sent to brexit@hpra.ie.