Guidance

UK-wide licensing for human medicines

Updated 12 March 2025

1. Overview 

This guidance is designed to provide information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework. 

From 1 January 2025 the Medicines and Healthcare products Regulatory Agency (MHRA) will license medicines across the whole of the UK ^{[footnote 1]}.  

​​​​​This guidance should be used in conjunction with the Human Medicines Regulations 2012 legislation, as amended by the Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 and other relevant MHRA guidance, including the UK-wide licensing for human medicines: supplementary guidance and labelling and packaging guidance.

2. Glossary of terms 

For the purposes of clarity and consistency, this guidance uses the following definitions of key terms: 

• UK-wide MA: a product licensed by the MHRA, across the whole of the UK, (this may include marketing authorisations (MAs) with a PL or PLGB prefix)
• NI MA (PLNI):  a product licensed by the MHRA that covers Northern Ireland (NI) only as the territorial application with PLNI as the MA number prefix 
• GB MA (PLGB):  a product licensed by the MHRA that covers Great Britain (GB) only as the territorial application with PLGB as the MA number prefix
• union authorisation:  a marketing authorisation issued by the European Commission for a product approved through the European Medicines Agency (EMA) centralised procedure
• centrally authorised product (CAP): a medicinal product authorised through a union authorisation issued by the European Commission and valid across the European Union 

3. UK-wide licensing 

From 1 January 2025, the MHRA will regulate medicines through UK-wide marketing authorisations (MAs). Any authorisation issued on or after this date, will have an MA number with a PL prefix. Medicines authorised before that date will retain their current MA number (including the prefix even if that is a PLGB prefix). This is explained in section 4 below.   

From 1 January 2025 union authorisations issued by the European Commission will no longer be valid for Northern Ireland. Instead, the MHRA will issue UK-wide authorisations for these centrally authorised products (CAPs).  

Marketing authorisation holders (MAHs) will not be able to apply for a GB MA (a PLGB covering only Great Britain) after 31 December 2024. The MHRA will retain the right to issue GB MAs ​​after 1 January 2025, but this will not be available through application. They will be issued only in exceptional circumstances to safeguard the interests of patients’ health in the UK.   

Applications to the MHRA that are pending on 1 January 2025 will follow the rules set out below for existing authorised products. Except for applications applied for through decentralised and mutual recognition procedures (MRP/DCP) for NI only, pending applications will be granted as UK-wide MAs but their MA number and prefix will be the one assigned at the time of application.   

4. Category 1 and Category 2 products 

From 1 January 2025, medicines that were previously within the scope of the EU centralised procedure will be authorised under UK-wide MAs and no longer be limited in territorial scope as GB MAs. These products will be designated in line with definitions in UK law as ‘Category 1’​. ​Category 1 includes the generic, hybrid or biosimilar products of Category 1 reference products. 

Medicines outside this scope (which can already be authorised as UK-wide MAs), will be designated as ‘Category 2’. 

Each application and existing authorised product will be assigned by the MHRA to one or other category. For medicinal products authorised until 31 December 2024, the Category 1 and 2 lists of individual products are available in the Category lists of products. From 1 January 2025, the categorisation of new products will be included in the lists of new marketing authorisations that are published every two weeks.

Categorisation criteria are summarised in Table 1 and explained in the subsequent paragraphs.  

Table 1: categorisation criteria 

UKMA (UK) Category 1	UKMA (UK) Category 2
Authorised products: Products that were authorised in the EU through the centralised procedure and subsequently grandfathered at the time of EU Exit.​  Or Are within the mandatory scope of the centralised procedure but authorised by MHRA since 1 January 2021. Or Are within the optional scope of the centralised procedure but authorised by MHRA since 1 January 2021, unless authorised by one or more member states through EU national procedures (including mutual recognition or decentralised procedures)	Authorised products: Products that do not fall within the mandatory scope of the centralised procedure ​ Or In the case of the optional scope, products were authorised through national procedures.​ Or Products were authorised prior to the introduction of the centralised procedure.
New applications: For products that fall within the mandatory or optional scope of the centralised procedure. This includes products authorised as conditional marketing authorisations.	New applications: For products that do not fall ​​within Category 1 (products that do not fall within the mandatory or optional scope of the centralised procedure). This will not include products authorised as conditional marketing authorisations.
Generic, hybrid or biosimilar products of category 1 reference products: For already authorised products, this will apply regardless of whether the centralised procedure was used for  the generic, hybrid or biosimilar application.	Generic, hybrid or biosimilar products of Category 2 reference products
These products will be authorised by the MHRA in accordance with UK law on a UK-wide basis.	These products will be authorised by the MHRA in accordance with UK law and applicable EU law[footnote 2] on a UK-wide basis.

4.1 Category 1 overview 

Category 1 products are those products that previously fell within the mandatory or optional scope of the EU centralised procedure. They will be licensed under UK law and on a UK-wide basis.  

4.1.1 New applications 

All products defined in Article 3(1) mandatory scope, and 3(2) optional scope, of Regulation (EC) No 726/2004 on Union Procedures and in the Annex to Regulation (EC) No 726/2004 will be Category 1 products. This includes all new active substances, orphan medicinal products, other innovative products, and advanced therapy medicinal products. It will include products authorised through a conditional marketing authorisation (CMA).  

The optional scope is defined as products meeting either of these criteria:  

• ​​​containing new active substances for indications other than those in the mandatory scope
• that are a significant therapeutic, scientific or technical innovation or whose authorisation would be in the interest of public health 

Category 1 includes generic, hybrid or biosimilar products of Category 1 reference products applied for under the conditions set out in the following legal bases: 

• generic: Regulation 51B Human Medicines Regulations 2012 (as amended) 
• hybrid: Regulation 52B Human Medicines Regulations 2012 (as amended) 
• biosimilar: Regulation 53B Human Medicines Regulations 2012 (as amended) 

All new licences issued will carry the marketing authorisation number with prefix PL.  

4.1.2. Existing authorised products  

For existing products this will include all new active substances, orphan medicinal products, other innovative products, advanced therapy medicinal products and other categories that are defined in Articles 3(1) and 3(2) and in the Annex to Regulation (EC) No 726/2004 on Union Procedures) as meeting any of the following criteria: 

• authorised for the EU through the EMA centralised procedure and subsequently grandfathered to GB MAs authorisations with effect from 1 January 2021
• within the mandatory scope of the centralised procedure but authorised by the MHRA since 1 January 2021 
• within the optional scope of the centralised procedure but authorised by the MHRA since 1 January 2021, unless authorised in the EU through national procedures, including MR/DC procedures

It will include products authorised through a conditional marketing authorisation. 

These existing products will have an MA number with the prefix PLGB and that will be retained after 1 January 2025. 

Category 1 includes generic, hybrid or biosimilar products of Category 1 reference products which were authorised by the MHRA or centrally by the EU regardless of whether the centralised procedure was used for the generic, hybrid or biosimilar application.   

This applies to applications made under the following legal bases: 

• generic: Regulation 51B Human Medicines Regulations 2012 (as amended) or Article 10.1 Directive 2001/83/EC 
• hybrid: Regulation 52B Human Medicines Regulations 2012 (as amended) or Article 10.3 Directive 2001/83/EC 
• biosimilar: Regulation 53B Human Medicines Regulations 2012 (as amended) or Article 10.4 Directive 2001/83/EC 

These existing products may have an MA number with the prefix PLGB or PL depending on whether or not the authorisation valid in NI was applied for through the centralised procedure. 

4.2 Category 2 overview 

All products that do not fall within the scope of Category 1 will be Category 2 products. Category 2 products are those that do not fall within the mandatory or optional scope of the centralised procedure as set out in detailed criteria above. No products authorised through a conditional marketing authorisation will be included in Category 2. These medicines will be licenced on a UK-wide basis. 

The Windsor Framework’s licen​s​ing changes do not impact medicinal products outside of the scope of the EU centralised procedure. Consequently, applicable EU law on medicinal products as amended prior to and by the Windsor Framework will continue to apply to these products after 1 January 2025. For the avoidance of doubt, all existing exemptions that apply to all UK medicines – for instance on the location of the MAH and batch testing – remain in place irrespective of category. 

4.2.1 New applications 

All products that do not fall within the scope of Category 1 will be Category 2 products.   

Category 2 includes generic, hybrid or biosimilar products of Category 2 reference products. 

All new licences issued will carry the marketing authorisation number with prefix PL.  

4.2.2 Existing authorised products 

Products that do not fall within the mandatory scope of the centralised procedure or, in the case of the optional scope, where the MA holder chose to use national procedures (including MRP and DCP) will be Category 2 products. 

Category 2 includes generic, hybrid or biosimilar products of Category 2 reference products. 

These licences may carry the marketing authorisation number with the prefix PL or PLGB depending on how they were originally licensed. 

4.3 Regulatory compliance 

For UK-wide MAs, the table below indicates where product categorisation will impact on regulatory compliance procedures. Further detail is explained in the links in the table to individual guidance documents.   

Table 2:  Regulatory compliance 

Compliance area	Category 1	Category 2
Pharmacovigilance	UK Requirements only	UK and EU requirements as applicable
Location of qualified person for pharmacovigilance (QPPV)	​​UK or EEA​	​​UK or EEA​
Territory where applicant for marketing authorisations must be established	UK or EEA	UK or EEA
Reference medicinal products (RMP) for generic/hybrid application	RMP must have a UK MA. Data and market exclusivity period starts on date of UK/ GB authorisation; or original EU authorisation for converted EU MAs.	RMP must have a UK MA. Data and market exclusivity period starts on date of UK/ GB authorisation including for cases authorised through EU mutual recognition or decentralised procedures.
Comparator product for bioequivalence or therapeutic equivalence testing	UK product or supported by data in UK guidance on comparator products	UK product or supported by data in UK guidance on comparator products
Requirement to add ‘UK Only’ label on packaging	Requirement applies	Requirement applies
Falsified Medicines Directive (for applicable products)	EU requirements disapplied	EU requirements disapplied
Paediatric requirements	UK requirements apply	UK and EU requirements apply
Orphan designation and rewards	UK regulations apply	Not applicable
Good manufacturing practice (GMP)	The Good Manufacturing Practice Directive has not been altered by the Windsor Framework. EU GMP applies in respect of Northern Ireland; and the EU GMP, modified by Schedule 2A of the Human Medicines Regulations applies in respect of Great Britain.	The Good Manufacturing Practice Directive has not been altered by the Windsor Framework. EU GMP applies in respect of Northern Ireland; and the EU GMP, modified by Schedule 2A of the Human Medicines Regulations applies in respect of Great Britain.
Location of qualified person (QP) – batch certification	The responsibilities of the QP (and RPi) are not altered by the Windsor Framework.	The responsibilities of the QP (and RPi) are not altered by the Windsor Framework.
Pharmacopeial standards	Compliance with pharmacopeial standards has not been altered by the Windsor Framework. European Pharmacopoeia and British Pharmacopoeia standards apply.	Compliance with pharmacopeial standards has not been altered by the Windsor Framework. European Pharmacopoeia and British Pharmacopoeia standards apply.

5. Territorial application 

From 1 January 2025 it will not be possible to simultaneously hold a UK-wide MA and a GB MA (PLGB) or NI MA (PLNI) for the same product. The guidance below outlines possible scenarios. 

5.1 Great Britain MAs (PLGBs) 

Subject to guidance under PLNIs below, by default, existing GB MAs will automatically be converted to UK-wide marketing authorisations on 1 January 2025, unless the GB MA is cancelled by the MA Holder or MHRA by 31 December 2024. 

No action is necessary for this conversion for marketing authorisation holders who only hold a GB MA for a particular product. The MA number including the PLGB prefix will not change after this conversion.    

However, MAHs will need to comply with the necessary requirements for labels, leaflets and packaging for medicines. This includes submitting updated packaging and labelling information to the MHRA where required. 

5.2 Northern Ireland MAs (PLNIs) 

5.2.1 MAH holds a NI MA and GB MA for the same product 

If a MAH currently holds both a NI MA and a GB MA for the same product and wishes to retain authorisation for the whole of ​the ​UK, the NI MA will need to be cancelled to enable the automatic conversion of the existing GB MA to a UK-wide marketing authorisation. The MAH cannot hold a UK-wide MA and a NI MA simultaneously for the same product. To cancel a NI MA, the MAH should: 

• inform the reference member state (RMS) of its intention to withdraw NI as a concerned member state (CMS) from the Mutual Recognition Procedure or the Decentralised Procedure (MRP/DCP)
• submit a request to the MHRA by 30 September 2024 to cancel the PLNI - the covering letter should refer to the Windsor Framework and specify the effective date of cancellation as 31 December 2024

The GB MA component will automatically convert to a UK-wide marketing authorisation on 1 January 2025. 

If the MHRA does not receive a request by 30 September 2024 to cancel the NI MA, the MHRA will automatically cancel the GB MA with effect from 1 January 2025. This means that only the NI MA will remain from 1 January 2025 and the product will no longer have a marketing authorisation for GB.  

The MHRA will co-ordinate cancellation of the NI MA with the automatic conversion of the GB MA to cover the whole of the UK. 

Where the MAH currently holds a GB MA and a NI MA (where the PLNI is authorised through the MRP/DCP), it is possible for the MAH to cancel the GB MA and retain only a NI MA through the MRP/DCP. 

5.2.2 MAH holds a NI MA (PLNI) only 

PLNI products can continue to be supplied to NI after 1 January 2025. 

Where a MAH holds a NI MA only and subsequently seeks authorisation for the whole of the UK, the NI MA will need to be cancelled prior to the granting of the UK-wide marketing authorisation. MHRA will co-ordinate these two actions. MAHs involved in EU procedures, with NI included as a CMS, will need to notify the RMS to withdraw NI as a CMS from the procedure. This must occur before the cancellation of the PLNI and the granting of the new UK-wide marketing authorisation. 

6. Existing UK-wide MAs granted through the MRP/DCP 

For existing UK-wide MAs granted through decentralised or mutual recognition procedures (MRP/DCP) before EU Exit (31 January 2020), where NI remains a CMS in the EU procedure, these can continue to be managed in alignment with the EU procedure, unless there is a requirement for UK-specific changes. In that situation NI will have to be withdrawn from the procedure and the existing UK-wide MA will then be managed as a standalone MA. 

7. Existing MA numbers before 1 January 2025 

The change in territorial scope of an existing licence will not result in a change in licence numbers or prefix. Medicines with existing PLGB numbers will become geographically valid UK-wide, where the GB MA converts to a UK-wide marketing authorisation. These medicines will retain the same licence number, including the prefix ‘PLGB’. ‘PLNI’ will continue to denote medicines that can be supplied to NI only. 

8. New applications for generics 

8.1. Reference medicinal products (RMPs)

Until (and including) 31 December 2024

8.1.1 Centralised products 

Until (and including) 31 December 2024 the EU remains responsible for authorising medicines in Northern Ireland that fall under the mandatory scope of the centralised procedure (mostly new and innovative products) and products in the optional scope if the EMA has agreed to that route of submission.  

UK-wide MAAs for generic, hybrid or biosimilar medicines of these products will need to cite the centrally authorised product as the reference product until (and including) 31 December 2024. The start date of the data and market exclusivity (DME) period will be the date of the European Union authorisation. 

8.1.2. All other products 

Applications for UK-wide generics, hybrid or biosimilar medicines of non-CAP products may cite a UK-wide licence as a reference product, or a European reference product (ERP) until (and including) 31 December 2024. The start of the DME period will be the corresponding date of the UK or European reference product.  

From 1 January 2025

Only RMPs that are, or have been, authorised for at least 8 years in the UK (or GB before 1 January 2025) will be valid for generic, hybrid and biosimilar MAAs received from 1 January 2025.  

Applications for medicines for which a valid RMP authorised in the UK cannot be established will need to be submitted under a different legal basis such as a well-established use application (regulation 54 of Human Medicines Regulations) or a full mixed dossier application (regulation 50 of Human Medicines Regulations). 

The current position on the use of international comparator products that applies only in GB, will be extended to cover the whole of the UK from 1 January 2025. This means that comparator products generally should be sourced from the UK. However, if the comparator product is not sourced from the UK market, the applicant should provide evidence that an international alternative is representative of the RMP. Further guidance on the suitability of RMPs for generic or hybrid applications and international comparator products are available in further guidance on RMPs. 

8.1.3 Category 1 products 

The MHRA will be responsible for authorising new and innovative medicines through the issuing of UK-wide authorisations.  

These products can then be cited as RMPs in applications for UK-wide generic, hybrid and biosimilar medicines.    

Valid RMPs will include converted EU authorisations (products authorised through the CAP grandfathering process) which are currently authorised as GB MAs and other suitable GB MAs, all of which will be converted to UK-wide marketing authorisations. 

8.1.4 Category 2 products 

Only products with a UK authorisation will be valid RMPs. The use of European reference products in UK-wide MAAs submitted from 1 January 2025 will not be possible. 

NI MA products: it will only be possible to cite ERPs for applications for NI MAs submitted through the EU MRP/DCP. 

8.2 Data and marketing exclusivity periods (DMEs) 

From 1 January 2025, the date used to calculate the DME period of RMPs will be that of the UK product. 

Where the UK RMP is a grandfathered EU CAP, the start date of the DME period, which was in effect on 31 December 2020, will apply. 

For NI MA applications authorised through the MRP/DCP, the DME periods relevant to the cited European reference product will apply.  

To avoid the possibility of multiple authorisations in the UK for the same product, NI MA applications will only be permitted where an MAH/applicant is solely applying for an authorisation in NI through MRP/DCP and does not have a pending application or granted authorisation for a GB MA or UK-wide MA for the same product. Any such GB or UK-wide application or granted MA would need to be withdrawn.

9. Summary tables of future licensing regime 

Tables 3 and 4 provide an overview of the current and future licensing regimes. The right-hand column highlights actions that are required by MAHs in respect of licensing. Conditions of licensing are subject to compliance with the MHRA labelling and packaging guidance. 

Table 3: current requirements and those applicable from 1 January 2025 depending on licensing route

	Position up to (and including) 31 December 2024	Position from 1 January 2025	Actions required from Marketing Authorisation Holders (MAHs)
New marketing authorisation applications (MAA) for product falling within the definition of the mandatory or optional scope of the centralised procedure	For GB: GB MA national authorisation including through the International Recognition Procedure, Project Orbis or Access.	UK-wide MA (Category 1) national authorisation, including through the International Recognition Procedure, Project Orbis or Access.	MAHs may apply for UK-wide ​​MAs only.
New marketing authorisation applications (MAA) for product in mandatory or optional scope of the centralised procedure	For NI: Union authorisation submitted to European Medicines Agency (EMA).	UK-wide MA (Category 1) National authorisation, including through the International Recognition Procedure, Project Orbis or Access. Applications to EMA no longer applicable in NI.	MAHs may apply for UK-wide ​​MAs only.
New marketing authorisation application for product not falling within the definition of the mandatory or optional scope of the centralised procedure	For UK-wide MA Or GB MA	UK-wide application (Category 2) including through the International Recognition Procedure, Access.	MAHs may only apply for UK-wide MAs except for authorisation for NI only made using the MRP/DCP.
New marketing authorisation application for product not in mandatory or optional scope of the centralised procedure	For NI MA	NI MA application via EU mutual recognition procedure or decentralised procedure (MRP/DCP).	MAHs may only apply for UK-wide MAs except for authorisation for NI only made using the MRP/DCP.
CAP bridging mechanism	Authorised UK-wide for up to 6 months following GB MA or until EC makes an authorisation decision on a parallel application through the European Medicines Agency (EMA). Supply of GB authorised products to NI may be permitted through NIMAR, Regulation 174 or Regulation 167 of HMRs.	Not applicable as the MHRA will authorise products within the scope of the centralised procedure in line with the processes outlined above.	No action required from MAH.  GB MAs will be become UK-wide authorisations from 1 Jan 2025.

^{Note: all MAHs must comply with labelling and packaging requirements of the Windsor Framework.}

Table 4: requirements for products with existing authorisations granted before 1 January 2025  

Position up to (and including) 31 December 2024	Position from 1 January 2025	Actions required from marketing authorisation holders (MAHs)
UK-wide MA	UK-wide MA (Category 1 or 2 depending on category rules). MA number may be PL or PLGB	No action required from MAH. MAHs may only hold UK-wide MAs, except in the case of an authorisation granted with NI as a CMS if using the MRP/DCP.
Separate GB MA and NI MA for the same product	Option A: UK-wide MA only (Category 1 or 2 depending on category rules)	By 30 September 2024 the MAH should inform the reference member state (RMS) of its intention to withdraw NI as a concerned member state (CMS) from the MRP/DCP and request the MHRA to cancel the NI MA, effective on 31 December 2024. GB MAs will convert to a UK-wide marketing authorisation on 1 January 2025 if the PLNI cancellation request has been made before 30 September 2024. If not, option B will apply.
Separate GB MA and NI MA for the same product	Option B: Retain NI MA only through the MRP/DCP	No action required from MAH. GB MA will be cancelled by the MHRA on 31 December 2024 as MAH cannot hold a UK-wide MA and NI MA.
NI MA through the MRP/DCP, with no PLGB for the same product	Maintain NI MA through the MRP/DCP only	Where a MAH subsequently applies for a UK-wide marketing authorisation, the NI MA will need to be cancelled prior to the granting of the UK-wide licence. The MAH should inform the RMS of its intention to withdraw NI as a CMS from the MRP/DCP.
GB MA only	UK-wide MA only (Category 1 or 2 depending on category rules)	No action required from MAH. PLGBs will be converted to a UK-wide marketing authorisation on 1 January 2025.

^{Note: all MAHs must comply with labelling and packaging requirements of the Windsor Framework.}

10. Further information 

For further information on the UK-wide licensing of medicinal products, see UK-wide licensing for human medicines: supplementary guidance which is designed to address common queries, or contact us by:  

• email:  ris.na@mhra.gov.uk

• telephone: 020 3080 600 

1. As amended by Regulation (EU) 2023/1182 and Directive (EU) 2022/642) ↩

2. SI 2021/1916  Human Medicines Regulations ↩