New Guidance on Parallel Import Licensing Applicable to Northern Ireland Under the Windsor Framework
Brexit brought new challenges to the pharmaceutical industry, one of them being the special situation of Northern Ireland (NI), which, although part of the UK, remained subject to EU law under the NI Protocol. Pharmaceutical products placed on the NI market had to comply with EU law. For import purposes this created de facto an EU border between NI and the rest of the UK (namely England, Wales, and Scotland). The Windsor Framework provides a new set of arrangements to restore the smooth flow of trade within the UK.
For further background on the Windsor Framework’s implications for pharmaceutical companies, see Marie Manley and Bronwyn Tonelli’s discussion here.
The UK parallel import licensing scheme (the Scheme) permits medicines that are already authorised by a Member State within the European Economic Area to be marketed in the UK, provided that the therapeutic action of the imported product is no different between those jurisdictions.
What does this mean for imports of medicinal products in the UK?
Under the current system, products imported in Northern Ireland (NI) require a Parallel Distribution Notice (PDN) issued by the European Medicines Agency (EMA) to parallel distributors to allow them to distribute centrally authorised product across the EU. Products imported into Great Britain (GB) post-Brexit require a Parallel Import Licence (PLPI) in line with the new requirements in the UK. Products subject to a PLPI are currently marketed as “GB Only.” From January 1, 2025, “GB Only” will become “UK Only” as NI will be included within the ambit of the Scheme and PDNs will cease to be valid in NI.
On April 5, 2024, the Medicines and Healthcare Products Regulatory Agency (MHRA) published guidance (the Guidance) regarding the implementation of the PLPIs to NI effective on January 1, 2025, pursuant to the Windsor Framework.
The Guidance provides key information on the implementation of PLPI to NI.
1. PLGB licence numbers and prefixes: Licence numbers will not change; however, the prefix will become “PLPI.” As a result, labels, leaflets, and packaging materials must be updated and/or amended to include the prefix “PL.”
2. “UK Only” label requirements: The “UK Only” label must be displayed on all UK licensed medicines. Guidance from the MHRA regarding best practice in the labelling and packaging of medicines can be found here.
3. Application of “UK Only” statement:
a. For products already on the market, the “UK Only” label should be added “at an appropriate regulatory opportunity where the label documentation is updated.”
b. For new product applications from April 5, 2024 to December 31, 2024, the “UK Only” label should be applied to the product at the time of application.
c. For new products from January 1, 2025, the packaging must display the “UK Only” label.
There are two options by which a PLPI licence holder may apply the “UK Only” label, both of which must be approved before January 1, 2025.
i. Stickering: A “UK Only” sticker may be added to the packaging in a clear, visible, and legible position via a permanent adhesive. The licence holder must submit a notification document for approval.
ii. Indelible:The “UK Only” label may be printed onto the label of the packaging directly. The licence holder must have approval of the artwork displaying the label.
4. Disapplication of EU Falsified Medicines Directive (EU FMD) safety features and encoding of pack information under UK law: From January 1, 2025, the EU FMD will not apply to PLPIs. EU FMD safety features will no longer apply to PLPIs. PLPI licence holders must ensure packs cannot re-enter the EU supply chain and are decommissioned appropriately. Further guidance on this can be seen here.
5. Supply of existing stock in existing packs: This is permitted until the product’s date of expiration. From January 1, 2025, the “UK Only” label must be in situ on new packs entering the UK market.
6. Early release to market: From April 5, 2024, to December 31, 2024, packaging must maintain compliance with the EU FMD. However, this does not preclude the ability to obtain approval from the MHRA (via notification or artwork approval, as discussed at item 3 (i-ii) above) and add the “UK Only” label to packaging ahead of January 1, 2025. It may be beneficial for new applications from April 5, 2024 to include the “UK Only” label (via sticker or indelible) as part of packaging design considerations.
A helpful summary table of the labelling and packaging requirements is provided in the guidance, as seen here. The MHRA provides useful guidance on the labelling and packaging of medicinal products for human use following agreement of the Windsor Framework, as seen here.
This Guidance provides needed clarity on the steps that parallel traders need to undertake ahead of January 1, 2025.
This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.
