Issue 76 (February 2024) of the HPRA Medicinal Products Newsletter has been published. As usual, it is packed with information and includes (but is not restricted to) the following information:
1) Clinical trials applications – Important dates and information
Applicants should make themselves aware of the following dates and deadlines in relation to the Clinical Trials Regulation (CTR).
- All clinical trials will be regulated under the CTR from 31 January 2025 and therefore ongoing trials authorised under the Clinical Trials Directive (CTD) must transition to the CTR in advance of this date.
- Sponsors should submit transition applications to the Clinical Trials Information System (CTIS) no later than 16 October 2024 to ensure review and authorisation.
- If a substantial amendment under CTD is required prior to transition, it should be submitted to the HPRA by 30 June 2024. These dates apply to all clinical trials including academic/non-commercial trials, and mono-national trials.
The above dates apply to all clinical trials including academic/non-commercial trials, and mono-national trials.
Further information on the Clinical Trials Regulation is available in this blog post.
2) Brexit and the Windsor Framework deadline of 31 December 2024
i) Exemptions granted including UK based batch release and QC testing
All Marketing Authorisation Holders (MAHs) for human medicines are reminded that the exemptions granted, to allow a transition period for medicinal products impacted by the UK becoming a third country, expire at the end of 2024.
- As a result, any companies relying on the exemptions, including UK based batch release and QC testing must bring their products into compliance or risk having their authorisation suspended.
- Companies that are having difficulties with compliance should contact the HPRA as a matter of urgency to consider any mitigating actions that may be taken.
ii) Joint outer packaging with the UK
In relation to the Windsor Framework, joint outer packaging with the UK for human medicinal products will no longer be feasible from the end of 2024, although existing packaging can continue to be placed on the IE market.
- The HPRA will help facilitate companies who wish to move to multi-labelled packs and are happy to engage with companies on transitional provisions.
- As many centralised products authorised through the EMA are currently jointly labelled with the UK, all MAHs with centralised products using joint packs are asked to contact the HPRA outlining their plans to separate their packs from the UK market
- Any companies which may have difficultly supplying the Irish market because of the Windsor Framework are asked to contact the HPRA as a matter of urgency.
- The HPRA will work with all MAHs to ensure continued supply to the Irish market.
- HPRA has also published a Q&A document on the implications of the Windsor Framework which is available here or via the HPRA Brexit latest information webpage.
3) Multilingual packaging pilot
The HPRA is reminding applicants for decentralised procedures (DCPs) of the importance of participating in the multilingual packaging pilot.
- This pilot allows applicants to agree a reduced text during the European phase of DCP procedures.
- The reduced text can then be applied to multilingual packs in the national phase and further discussions on reductions are not expected.
- Multilingual packages can be discussed and prepared outside of the pilot for new and existing products.
- However, the HPRA considers it important to avail of the pilot opportunity to streamline their preparation.
- Multilingual packaging has important benefits, considering the limitations of Brexit and the Windsor agreement on joint packs historically shared with UK.
- The HPRA remains available to advise on issues regarding multilingual packs with IE.
- Applicants can find further information and guidance in the latest version of the CMDh Best Practice Guide on Multilingual Packaging which is available on the CMDh website under ‘Application for Marketing Authorisation’.
Source: HPRA