Time-limited conditional exemptions to facilitate supply of medicines to the Irish market after Brexit
As outlined on the HPRA website on 1 January 2021, the European Commission has published a Notice on ‘Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period’.
This notice outlines that due to the historical dependence of Ireland (IE), Malta, Cyprus and Northern Ireland (UK (NI)) on medicines supplied from Great Britain, in the exceptional cases where additional time is required to transfer certain functions to EU/EEA, and in the exceptional circumstance of a global pandemic, an additional period of up to one year (Jan 2021 to 31 Dec 2021) to comply with aspects of the Union’s acquis, has been agreed. These exemptions, which are applicable for medicinal products and investigational medicinal products are as follows, and are subject to certain conditions:
Medicinal products or investigational medicinal products can be imported from Great Britain into one of the above markets by wholesalers/importers which do not hold the relevant Manufacturer’s/Importer’s Authorisation to act as the site of physical importation and/ or to act as the site of batch release for those markets. This means that medicines and investigational medicinal products can be imported from Great Britain into one of the above markets and placed on the market in accordance with Union law, having been subject to batch release by a Qualified Person (QP) in Great Britain applying equivalent quality standards to those laid down in Union law, thus ensuring an equivalent level of protection of human and animal health.
Medicines can be imported from Great Britain into one of the above markets and placed on the market in accordance with Union law having undergone quality control testing in Great Britain, in line with Article 20 (b) of Directive 2001/83/EC for human medicinal products or Art 24(b) of Directive 2001/82/EC for veterinary medicines.
Article 22 of the Commission Delegated Regulation (EU) 2016/161 on safety features obliges wholesalers to decommission unique identifiers (UIs) on products they intend to distribute outside of the Union. The conditional exemptions include a provision that allows a 12 month exemption from decommissioning the UIs on joint EU/UK packs that are intended for export to Great Britain.
The presence of UIs on the medicinal products imported into, Ireland, Northern Ireland Cyprus and Malta through Great Britain is an essential requirement as regards ensuring a high level of public health protection. The presence of UIs can only be achieved at present, if wholesale distributors, located in the Union, do not decommission the UIs on medicinal products in joint packs.
In order for the MAH (which must be established in the Union) or EU-based sponsor/legal representative for a clinical trial, to apply for this time-limited conditional exemption, a request form must be submitted to the HPRA for the evaluation of your request (no later than 30 Jan 2021 where it relates to quality control (QC) testing). Please send to Brexit@hpra.ie for human medicines and email@example.com for veterinary medicines requests. Approval of this request will be primarily based on the information provided and the conditions agreed to by the applicant in this form, which should be carefully completed according to the instructions provided within. The exemptions relating to batch release and QC testing are intended to allow these activities to continue for a short period of time at currently registered sites in Great Britain to facilitate continued supply of medicines while these functions are being transferred to sites in the Union or Northern Ireland. Please note that these exemptions may not generally be availed of where the specific functions have already been transferred to EU/EEA sites. As part of the exemption there is a requirement to provide regular updates on progress towards compliance to HPRA.
Acceptance, by the HPRA, of any requests for exemptions, applies only to medicinal products/ investigational medicinal products supplied to the Irish market/clinical trials being carried out in Ireland. The exemptions are limited in time and will expire no later than 31 December 2021.
There will be no fee for these exemption requests.