Questions and Answers on the Windsor Framework and medicines for human use

The WF was implemented in Regulation (EU) 2023/1182 and was directly applicable from 1st January 2025.

The WF removes the possibility for jointly labelled medicines with NI/GB/UK. This is because UK medicines will now be required to carry the words "UK only" on the outer packaging and will not be permitted to carry the 2-D matrix serialisation safety feature that has been uploaded to the EMVO repository as required by the Falsified Medicines Directive.

The WF came into effect for medicines for human use on the 1st of January 2025.

Any batches of joint labelled IE/UK medicines, batch released for the IE/UK markets, before 31st December 2024 can remain on the market until the expiry date of the medicines. This applies both in IE and the UK. In other words, the provisions of the WF only apply to product batch released after 31st December 2024.

No. product placed on the NI (and GB) market will carry the words “UK only” on the outer packaging and will be prohibited from carrying the 2-D matrix serialisation safety feature required by the Falsified Medicines Directive.

Yes. Where the information in the package leaflet and the immediate packaging remains the same in both jurisdictions apart from the administrative details (i.e. consistent with the authorisation in IE and UK), then the administrative details from both jurisdictions can be included on the package leaflet and inner packaging.

For national authorised products it is not necessary to submit an Article 61(3) application to the HPRA for assessment when removing or changing the administrative information for an EU member state (MS) or the UK placed within the ‘blue box’, which does not affect any other aspects of the layout and font size of packaging, labels and leaflet text (Section 4.3.1 of HPRA Guide to Labels and Leaflets of Human Medicines). For products authorised through the centralised procedure the marketing authorisation holder should submit, to the EMA, a dedicated notification under Article 61(3) of Directive 2001/83/EC.

The guidance outlined in this Q&A also applies when product information is being updated to remove a local representative for NI or UK. An Article 61(3) application is not required for nationally authorised products but is required for centrally authorised products.

It is understood that this question relates to using pre WF approved (joint) packaging for the IE market only. Nationally and centrally authorised products which are in accordance with the Irish/EU authorisation can continue to be released on the Irish market using pre WF approved packaging with UK information, but the expectation is that this is a transitional provision, and the product outer packaging should be updated when other changes to the packaging are required. Marketing Authorisation Holders must have updated their labelling to remove all NI/UK administrative details by 31st December 2027. This only applies to the outer carton when the immediate label and/or the package leaflet is jointly shared with the UK.

Yes, the 'UK only' label can be covered over with a label as long as the label is permanently attached to the outer carton/bottle and cannot be removed. The label must not cover any text on the carton/bottle and must not affect the readability of the outer labelling. The label must completely cover the 'UK only' label text. To register the over-labelling the MAH must provide updated mock-ups to the HPRA by way of an article 61(3) application. Over-labelling is considered a manufacturing operation and therefore this operation must be conducted in a site that holds a valid manufacturer's authorisation.

Yes, the 'UK only' label can be covered over with a label as long as the label is permanently attached to the outer caron and cannot be removed. The label must completely cover the 'UK only' label text. In justifiable cases, the addition of the 2-D matrix serialisation safety feature is permitted as long as the label is attached to the outer carton/bottle and cannot be removed without being damaged. The over-label must fulfil the quality of the printing requirements set out in Article 6 of the Commission Delegated Regulation (EU) 2016/161 (case C 147/20, Novartis Pharma GmbH v Abacus Medicine A/S). The human readable text for the PC, SN, Lot and EXP Date will need to be placed beside the 2-D matrix serialisation safety feature.

Over-labelling must not cover any statutory text on the carton/ bottle and must not affect the readability of other required labelling text. If there is an existing barcode on the IE/UK pack that could be confused by the end user with the 2-D matrix serialisation safety feature this should be covered over, ideally with the EU 2-D matrix serialisation barcode.

Over-labelling is considered a manufacturing operation and therefore this operation must be conducted in a site that holds a valid manufacturer's authorisation and in accordance with Good Manufacturing Practices. To avail of the flexibility to add the 2-D matrix by way of an over-label the MAH must contact the HPRA using the brexit@hpra.ie with a justification as to why this flexibility is needed. The HPRA will consider the justification and revert with our approval or otherwise.

To register the addition of these over-labellings, the MAH must provide updated mock-ups to the HPRA by way of an article 61(3) application.

The WF introduced additional provisions relating to medicinal products for human use intended to be placed on the market in Northern Ireland. It is the HPRA’s understanding that aside from these additional provisions, the previous specific arrangements in relation to Northern Ireland as reflected in previous HPRA guidance, EMA guidance and European Commission communications remain unchanged.

As reflected in the Notice to stakeholders issued by the European Commission and the EMA in March 2020 following the withdrawal agreement and the Northern Ireland protocol, that protocol includes specific provisions relating to Northern Ireland which would differentiate Northern Ireland from the standard approach that would apply in relation to a third country.

Medicines moving from Northern Ireland (NI) to the Republic of Ireland (IE)

Article 7 of Regulation (EU) 2023/1182 introduced a new provision which states that medicinal products as referred to in Article 1(1) of that Regulation shall not be moved from NI to a Member State or be placed on the market in a Member State. Article 1(1) specifies that the scope of the Regulation includes medicinal products intended to be placed on the market in NI in accordance with Article 6 of Directive 2001/83/EC. Based on this, authorised medicines intended to be placed on the market in NI cannot be moved into IE or any other EU Member State. We therefore understand that parallel exports from NI are no longer possible. Medicinal products not intended for or placed on the NI market can continue to be wholesaled, manufactured and batch released from NI to the EU.

Exempt medicinal products

The movement of UK or NI packs from NI to IE, intended to be supplied under Article 5(1) of EU Directive 2001/83/EC as exempt medicinal products (EMPs) will still be permitted where an authorised equivalent product is not available in Ireland, in line with the requirements outlined in the HPRA Guide to the Notification System for Exempt Medicinal Products. These packs may not leave the Irish market, as their supply to IE from NI is based on national EMP provisions to facilitate such supply to Irish patients in circumstances where a specific medicine they require is not available in IE. To ensure this, IE wholesalers receiving UK or NI authorised packs from NI suppliers on this basis, should only supply to customers that are authorised to supply medicines to patients (e.g. hospital and retail pharmacies). Onward supply to other wholesalers is not permitted.

Medicines moving from the Republic of Ireland (IE) to Northern Ireland (NI)

The movement of medicines from IE to NI is not considered export from the EU. All usual regulatory requirements apply i.e. that the product supplied is appropriately authorised for the intended market, or where it is supplied as an unlicensed medicine all local requirements of the destination market are met.

As indicated in footnote 45 of the Notice to Stakeholders issued by the European Commission and the European Medicines Agency, batch release by a Qualified person of an importer / manufacturer established in NI is recognised in the EU as per the sixth subparagraph of Article 7(3) of the IE/NI protocol. The same subparagraph also refers to batch testing.

Yes, QPs can use quality control data generated in the UK prior to 11 pm on 31st December 2024, under a derogation, to batch release product for the Irish market in 2025.

Product that was batch released for the IE market prior to 11 pm on 31st December 2024 and dispatched for the IE market pre year end can be placed on the market post year end. This product can be received under a Wholesaler's Distribution Authorisation in Ireland if this was facilitated by a derogation prior to January 2025.