Windsor framework

Question 1

When does the Windsor Framework kick in?

Answer 1

01 Jan 25

Question 2

What are the main points of Windsor framework?

Answer 2

1 All new medicines and medicines in Northern Ireland that currently fall under the scope of the EU Centralised Authorisation Procedure will be authorised by the MHRA for the UK market.
2 These products will only be able to be sold in the UK and export markets where it is lawful for them to be placed on the market or supplied as unlicensed medicines. These products will not be available as marketed product in in Ireland or elsewhere in the EU.
3 Packaging for all products for the UK market must carry a clearly legible ‘UK Only’ label
4 Joint packs between the UK and EU will no longer be possible. -PLGB licences will become UK wide Mas

Question 3

How long can stickers be used

Answer 3

6 months – until 30 Jun 25

Question 4

Does existing product on the market need to be reworked wrt Windsor Framework

Answer 4

No – existing product on the market before 01 Jan 25 can s

Question 5

Can PLGB packs QP certified before 01 Jan 25 be placed on NI market after 01 Jan?

Answer 5

Only if they are marked UK only. No UK Only then not allowed on market unless they are NIMARs

Question 6

What are the FMD requirements after 01 Jan 25

Answer 6

The 2D code must not work in the EU database. If it still works then it must be covered.
For UK, FMD optional

Question 7

Will the NIMAR list be withdrawn due to Windsor Framework>

Answer 7

The NIMAR list will remain in force to continue to facilitate the supply of packs into Northern Ireland were there to be circumstances where no alternative authorised medicines are available

Question 8

Can you apply UK only labels ahead of 01 Jan

Answer 8

Yes

Question 9

Can the new Windsor artwork be used willy-nilly?

Answer 9

No - Before implementing any new artwork changes, companies must notify the MHRA and have until 31 December 2024 to do so.

Question 10

How to inform MHRA of Windsor artwork change

Answer 10

3 ways:

1) Any regulatory opportunity
any variation you’re submitting other than type 1A
2) Self-certification
Submit a separate self-certification notification specifically for the Windsor Framework artwork change to be registered and tracked through the MHRA’s regulatory management system. No need to wait – can then do
3) Self-certification without initial electronic Common Technical Document (eCTD)
do the initial application through MHRA portal and then submit updated eCTD before 31 Dec 25

Question 11

what are Homeopathic (NR and HR) medicinal product

Answer 11

Homeopathic medicinal products are categorized into two main types in the UK: NR (National Rules) and HR (Homeopathic Registration).
1. NR (National Rules): These products are registered under the National Rules Scheme, which allows them to be marketed with specific therapeutic indications. They must meet certain standards of safety and quality but do not require evidence of efficacy.
2. HR (Homeopathic Registration): These products are registered under the Simplified Registration Scheme, which does not allow them to make specific therapeutic claims. They must also meet safety and quality standards but are generally used for minor conditions and self-limiting ailments12.

Question 12

Do homeopathic and traditional herbal product need UK only?

Answer 12

Packaging for all UK Homeopathic (NR) medicinal products should state ‘UK Only’

UK Herbal (THR) and Homeopathic (HR) medicinal products do not require a ‘UK Only’ label to be applied to packs but encouraged to do so for consistency

Question 13

Will PLGB licence numbers change as a result of Windsor framework?

Answer 13

No – number stays the same but becomes PLUK

Question 14

Can there be EU/UK packs with Windsor Framework?

Answer 14

Nope – another Brexit bonus. From 1 January 2025, joint EU/UK packs can no longer be released to the UK supply chain.

Question 15

What are the requirements for PLUK product labelling before 01 Jan 25?

Answer 15

• The ‘UK Only’ label can be applied to packaging and released to the UK market before 1 January 2025.
• UK-wide MA packs will need to remain compliant with EU FMD requirements until 31 December 2024 and be disapplied from 1 January 2025

Question 16

What are the requirements for PLGB product labelling before 01 Jan 25?

Answer 16

• The ‘UK Only’ label can be applied to packaging and released to the GB market before 1 January 2025. PLGBs are not required to have FMD features anyways.
• QP-released PLGB packs meeting these requirements will be valid for immediate supply to the Northern Ireland market after 1 January 2025. QPs should have mechanisms in place to ensure PLGB packs meet the no EU FMD working requirements prior to release.

Question 17

If going down the UK only sticker route, where and when should this be done?

Answer 17

• The application of a ‘UK Only’ sticker will need to be done prior to certification by a Qualified Person (QP). The stickering must be completed by the site named on the Marketing Authorisation (MA) prior to QP Certification

MA holders who initially wish to apply the ‘UK Only’ statement by means of a sticker will need to provide an updated mock-up of the outer packaging to the MHRA, indicating where this will be placed on the carton

Question 18

What are the requirements for the UK only artwork

Answer 18

• ‘UK Only’ may be presented anywhere on the outer packaging only of the medicine.
• The text must be conspicuous and clearly legible, at least 7-point font and in line with current MHRA expectations

Question 19

What is the Windsor impact on parallel importation?

Answer 19

The MHRA will license all medicines across the whole of the UK and PDNs (EU Parallel Distribtion Notifications) will no longer be valid in Northern Ireland. This means that:
* All Parallel Imports (including Centrally Authorised Products) will be authorised to be marketed across the whole of the UK.
* All Parallel Imports will need a valid PLPI licence.
* All PLPIs with a current territorial limitation of GB will be converted to UK-wide authorisation automatically. This includes: all previous Parallel Distributed Notices (PDNs) that were converted to UK Parallel Import Licences (PLPIs) and any other PLPI licences that have a current GB territorial limitation. *A variation will not be required to change the territory from GB to UK-wide.

Question 20

Wrt Windsor, what do QPs need when certifying packs in UK that are imported from EU?

Answer 20

written assurances or evidence from suppliers that:
-Where a pack displays a 2D barcode, this is not an FMD-compliant barcode, meaning one recognised by the EU repositories system.
* If an FMD-compliant barcode, meaning one recognised by the EU repositories system, were to be present, this has been fully removed or covered. As noted above, other 2D barcodes may be present.
Any company parallel importing medicines from the EU must seek written assurances or evidence from suppliers that goods have been decommissioned prior to receipt into the UK as UK companies will be unable to independently verify this activity has occurred.

Question 21

What are Category 1 and Category 2 products wrt Windsor framework

Answer 21

Cat 1 = ex CAP products

Cat 2 = everything else

Question 23

What are Category 1 and Category 2 products wrt Windsor framework

Answer 23

Cat 1 = ex CAP products

Cat 2 = everything else

Question 24

What is the main difference between Cat 1 and Cat 2 products?

Answer 24

Cat 1 = UK only pharmacovigilance requirements whereas Cat 2 is both UK and EU requirements