Medicines: apply for a variation to your marketing authorisation

  Overview

Variations are either:

• an administrative change such as a change of company name and/or address
• a change to the characteristics of a product that can affect its quality, such as a change to its composition, method of manufacture or how it is tested
• a change which may affect the safety, efficacy or pharmacovigilance requirements of the product

Changes are classed as major (Type II) or minor. Minor changes are either Type IA or IB.  These classifications are explained in Sections 5 and 6 below.

Applicants can apply for:

• a single change to one marketing authorisation (MA)
• multiple changes to one or more MAs (refer to Section 11)

  Marketing Authorisation Types

From 1 January 2025, the following Market Authorisation (MA) types are available in the United Kingdom (UK):

• UK-wide MA – these products are authorised for sale and supply throughout the United Kingdom
  • as a purely national UK-wide MA regardless of the route of application: direct national, International Recognition Procedure (IRP), Project Orbis, Access.
  • as a UK-wide MA that was granted as part of a Mutual Recognition/Decentralised (MR/DC) procedure involving UK as Concerned Member state (CMS) before 1 January 2021.  The MA holder has the option to continue to manage the MA in line with the MR/DC procedure with Northern Ireland (NI) remaining as a CMS.  Note that UK-wide MAs can no longer be applied for through EU procedures.
• NI Only MAs (PLNI) – these products are authorised for sale and supply in Northern Ireland only as part of an MR/DC procedure including Northern Ireland only as a concerned member state (CMS).
• Centralised Marketing Authorisations and subsequent variations ceased to have validity in Northern Ireland from 1 January 2025.

For further information on these authorisation types refer to guidance on UK-Wide Licensing of Medicines https://www.gov.uk/government/publications/uk-wide-licensing-for-human-medicines.

  UK Variations procedures

The procedures detailed under Chapter IIa of the EU Variations Regulation (EC) No 1234/2008 regarding variations to the terms of marketing authorisations for medicinal products for human use, which applies to variations to purely national Marketing Authorisations (MA) in the European union (EU), were incorporated into UK law on 31 December 2020. They continue to apply to variations to purely national UK marketing authorisations as set out in regulation 65C and Schedule 10A to the Human Medicines Regulations 2012 (as amended) “the HMRs”. 

Commission Regulation 2024/1701 of 11 March 2024 amending the Variations Regulation (EC) No 1234/2008, has also been implemented in the UK. It entered into force on 7 July 2024 and became applicable on 1 January 2025.

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202401701

Subsequent to that revision of the Variation Regulation applicable since 1 January 2025, the European Commission (EC) has published a communication which sets out guidance on the various categories of variations and operation of the procedures (Communication 2025/5045 dated 22 September 2025):

 https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:C_202505045

3.1  Implementation of new guidelines

• The new guidance on procedures and categories of variations applies from 15 January 2026.

The application procedure which will be followed for the different types of UK Marketing Authorisations from 1 January 2025 is dependent on the regulatory authority responsible for leading the assessment: MHRA for purely national variations, the Reference Member State for Mutual Recognition (MR) variations or the Reference Authority for any EU work sharing variations. Therefore the MHRA guidance should be read in conjunction with guidance on the EMA and CMDh websites:

https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/variations-including-extensions-marketing-authorisations

https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation/amended-variation-regulation.html

Type IB and Type II Variations

Until 15 January 2026, marketing authorisation holders should continue to rely on the current Variations Guidelines and procedures.  Variations submitted after this date should use the new variations guidance.  

Type

 Type IA variations

The date of implementation of the change(s) in the quality management system of the marketing authorisation holder (MAH) should be used to determine whether the new  Variations Guidance applies (rather than the date of submission used for type IB/II variations).

For Type-IA variations implemented before 15 January 2026 should be submitted before 15 January 2026 either as an early annual update or as individual notifications. 

For Type-IA variations implemented on or after as of 15 January 2026, the first type-IA variation implemented will start a new cycle for the annual update, unless one of the listed annual update exemptions applies to that variation (refer to Section 5).

  UK Variations Classification

Until further notice the EU variations classification guideline, which explains the type of variation (Type IA, Type IAIN, Type IB, Type II or Extension) to submit will continue to apply to all types of variations in the UK unless and until the MHRA  issues any revised guidance.  Where relevant, the guidance also explains conditions to be met and any required supporting documentation which is a fundamental component of the operation of the variations system.,

The new Variations Guidelines on the details of categories of variations and on the documentation to be submitted will apply from 15 January 2026 unless they are strain/sequence changes to authorised COVID vaccines.

• Specific arrangements for changes to Covid vaccines in the UK are explained in Section 7.

Any changes to the product that require a marketing authorisation extension application should be submitted in accordance with the procedures for new marketing authorisations.  

  Minor variations

These are divided into two types: IA and IB.

Type IA Variations

Type IA changes have little or no impact on the quality, safety or efficacy of the product, for example administrative modifications such as:

• the manufacturer’s name
• a minor change to a control method
• deleting information of where the product is packaged

Type IA variations are ‘do-and-tell’ procedures, where the MA Holder must implement the change before notifying the MHRA. Notification must occur not later than 12 months, after implementation. However, some Type IA changes require immediate notification (Type IAIN) and must be submitted immediately after implementation.

If the implementation period for any Type IA variation exceeds 12 months without a variation being submitted, a default Type IB variation must be submitted. The MHRA will take up to 30 days to process the application.

Type IA notifications may cover multiple changes across one or more Marketing Authorisations. These should be submitted as a Grouped Variation.  When more than one Marketing Authorisation is involved, all changes must apply to all Marketing Authorisations within the collection.

Implementation is considered to be when the company makes the change to its own quality system. For changes affecting product information it is when the company internally approves the revised product information for use in the next packaging run.

The MA Holder must submit Type IA variations as follows:

Type IA Annual Update Notifications

Type IA variations that do not require immediate notification following implementation must be bundled and submitted as an annual update to each MA. The changes do not need to be related to each other.  These notifications must be submitted not earlier than 9 months from the first implementation but not later than 12 months of the first implementation.  They can be submitted outside the annual update if one of  the following applies:

(i) the change has already been submitted as part of an acceptable grouping of variations of other types (Type IB or Type II or Type IA)

(ii) the change has already been submitted as part of a Type IA grouping which included a Type IAIN change

Type IAIN variations should be submitted immediately (see section on Type IAIN changes). They may only be added to an annual update if this is submitted immediately after the implementation of the Type IAIN changes.

(iii) the change is submitted as part of a Type IA UK super-group application where one or more changes are being submitted across MAs held by multiple MA Holders belonging to the same legal group of companies.

(iv) the change is an exceptional case listed in CMDh guidance Chapter 6, section 2:  https://www.hma.eu/human-medicines/cmdh/procedural-guidance/variation.html.  Exceptions relying on the need to mitigate a predicted or actual shortage should be supported by evidence of this in the UK. 

When submitting a Type IA variation earlier under the exceptional case criteria, the basis for the exception must be clearly specified in both the cover letter and the ‘Scope and Background for Change’ section of the application form.

Type IA Immediate Notifications (IAIN)

Type IA Immediate Notifications are a sub-type of Type IA variations and are also ‘do-and-tell’ procedure. Type IAIN changes must be submitted immediately after implementation, with a period of 2 weeks being considered as reasonable. They can be submitted as part of a grouped variation or as part of the annual update provided their submission is not delayed.  A minor change would usually be Type IAIN if it interferes with the ability to continuously supervise the product.

All relevant conditions and documentation requirements specified in the classification guideline for Type IA variations must be met. Complete the application form (eAF  https://esubmission.ema.europa.eu/eaf/) with relevant checkboxes selected. If a condition or documentation requirement is not applicable, specify N/A and add justification under “Note”.

No ‘requests for further information’ (RFI’s) are issued for Type IA procedures, the applications are either accepted  or rejected. There is no application fee associated with a National Type IA/IAIN. A full list of fees and further information about fees, can be found in the section fees for licence variation applications.

See also the CMDh variations procedure guidance for the details of this type of change.

Type IB change

If the change is more significant than a Type IA change but is not a Type II change or an extension application, it is considered a Type IB change. MHRA must approve Type IB changes before they are implemented. Many of these are changes to module 3 on the manufacturing or testing procedures.

See also the CMDh variations procedure guidance for the details of this type of change.

Once the MHRA has all the necessary documents, it takes up to 30 days to process the variation application. A further 30 days is permitted for the applicant to respond to any requests for information letter, which for Type IB are referred to as Notification with Grounds letters (NWG).

• NWGs are seen as a conditional determination of a Type IB variation, where the applicant has one opportunity to address any deficiencies or omissions. If the applicant does not reply in full to a NWG the variation will be refused, this also applies if only a partial response has been received by the 30-day deadline.

  Major variations (Type II)

These changes are more complex and are anticipated to have a significant impact on the quality, safety and/or efficacy of the product.

The MHRA needs to approve major variations before they are implemented. One example of a major change is adding a new therapeutic indication to a product or updating the current indication.

See also the CMDh variations procedure guidance for the details of this type of change.

Once MHRA has all the documents, it will take 22-days, (reduced timetable), 60-days (standard timetable) or 90-days (extended complex timetable) to assess the application depending on how urgent or complex the changes are, excluding time taken to answer questions.

With a period for the applicant to respond to any requests for further information (RFIs) necessary to reach a decision, assessment timeframes become 30, 90 and 120 days respectively.

The table below explains the type II timetables.timetables

Stage	30-day procedure	90-day procedure	120-day procedure
Start assessment-clock on	Day 0	Day 0	Day 0
Assessment done
Approved, refused or withdrawn (procedure finalised)	Day 22	Day 60	Day 90
or
RFI issued - clock off (procedure suspended)	Day 21	Day 59	Day 89
Amended application for applications with an RFI step
Timescale for receipt of response	10 days	60 days	90 days
Response received-clock on completion of processing (excluding clock off time)	By day 30	By day 90	By day 120

A reduced Type II procedure (reduced from 60 days to 30) is for variations concerning safety issues and is agreed between the MHRA and the Marketing Authorisation Holder (MAH) and in general will be changes to the SmPC, requested following the assessment of a Periodic Safety Update Report (PSUR) or at the request of the MHRA Pharmacovigilance Unit.

Requests for a reduced timescale should be made to variationqueries@mhra.gov.uk

All other forms of submission will be rejected.

  Changes to Covid Vaccines

Seasonal strain/sequence (COVID variant) changes to existing licensed COVID vaccines should be made to the MHRA via a line extension application (not a Type II variation), after requesting a new PL number. Additional strengths, pharmaceutical forms or presentations (e.g. vial or pre-filled syringe) for the new strain should be submitted as separate line extensions (refer to section 9, extension applications), although these can be submitted at the same time as a bulk submission.

Where strain/sequence changes have been authorised in another region via a Type II variation, this can be submitted via IRP with the same supportive data and the relevant variation assessment report(s); however, the application should be submitted to the MHRA as a line extension.

  Common invalidation errors and pre-submission checklist

Following analysis of submissions, the MHRA is developing a pre-submission checklist for variations which will be published in due course.

These are areas of common invalidation errors:

• C.I.2.a Type IB Variations: where changes are made to the Summary of Product Characteristics (SmPC), Labelling, or Package Leaflet of a generic/hybrid/biosimilar medicinal product, following assessment of the same change for the reference product, specify the Reference Product used for the Marketing Authorisation Application (MAA). Use an alternative product, with justification, only if the original is cancelled or out of date.
• Cover Letter Requirements for IRP Variations: Complete and include an IRP submission checklist with each Type IB or Type II IRP variation. The checklist can be downloaded from https://assets.publishing.service.gov.uk/media/66a8f0cb0808eaf43b50d9e7/IRP-PostLicensingSubmissionChecklistV1.2.pdf.
• ASMF: Include a declaration that the ASMF Holder has submitted all parts of the ASMF, including approved variations and assessment reports. Include a letter for permission of access.
• SmPC Fragments: Include tracked SmPC and SmPC fragments in the working document folder of the sequence. See section below for further information.
• Grouped Type IB and Type II Variations: When grouping is not an example already covered in the Variation Regulation, obtain prior approval from the Customer Experience Centre. Submit grouping requests to variationsqueries@MHRA.gov.uk.

The marketing authorisation holder (MAH) is responsible for ensuring that all relevant conditions and documentation are met and the submission of this information and dossiers are the most recent and up-to-date. Deficient or incorrect documentation can lead to invalidation and/or rejection of the variation.

Further detail on certain changes is published here:  [add link to supplementary guidance]

  Extension Applications

In cases where the impact of a proposed change to the product is so significant it will need to be applied for as a line extension through a new MA application.  The application process to apply for a new MA will need to be followed.

Examples of circumstances where a new MA is required:required are:

• changes to the active substance(s), including the salt/ester, isomer or biological active substance
• changes to strength or pharmaceutical form

• ·       changes to the route of administration including different routes of parenteral administration

Note the UK position on changes to Covid vaccines explained in section 7 of this guidance.

See annex 1 of the variations regulations for more information on extensions. 

Revised labels, leaflets and/or packaging

If the variation applied for affects details of the labels, leaflets and or packaging of the product, (e.g. a change of manufacturer) updated versions will need to be included with the variation submission to be assessed.

A variation is not needed if there hasn’t been a change to the product and only style changes are proposed for the labels, leaflets and/or packaging.

See patient information leaflets for guidance on how to submit these types of changes.

Submitting Multiple Changes

Multiple Changes to a single MA (grouping)

Multiple changes to a single product can be made using the ‘grouping’ format, if the changes are directly related.

For example, a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to a single product. Grouping advice is in the annex III of the variations Regulation and Schedule 10A of the Human Medicines Regulations and in MHRA published advice:  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/369000/Examples_of_groupings.pdf 

If a Type IA variation is included in a group with other types of variations, the MA holder may consider holding release of batches until all changes in that group have been approved.  Should the Type IA variation be dependent on other changes in the group and the group is rejected,is

 rejected implementation of the Type IA change would have to cease. 

The type of procedure (Type IA, IB, II) depends on the extent of the change. The assessment time frame and applicable fee are determined by the variation with the highest classification in the group.

If the proposed group of changes isn’t included in the guidance or the examples, complete the grouping template, copy and paste it into the main body of an email and send it to variationqueries@mhra.gov.uk before submitting the application. The MHRA aims to confirm acceptability of the grouping within 7 working days.

Applicants should reference the grouping approval in both the cover letter and application form. Additionally, include a copy of the approval email from CEC in the application.

Same variation(s) to multiple products (bulk submissions)

It is possible to submit the same Type IB or Type II change or group of changes to multiple MAs held by the same MA holder as ‘bulk’ applications.  Companies within the same legal group or are licensees are considered to be the same MA holder for this purpose. (Commission Communication (98/C 299/03)).  If there is a group of changes then Type IA variations may also be included where they are consequential or related. Bulking does not impact on the procedure timescale.

• To avoid duplication of effort for applicants and the MHRA, a bulk variation should be submitted in situations where the same variation is applied to multiple MAs from the same MA holder.

Supergrouping of Type IA and IAIN Variations

It is possible to bulk and submit a single application for the same Type IA and Type IAIN variation or group of variations to products held by different licence holders, providing the MA Holders belong to the same mother company, or group of companies or which are ‘licencees’.  These companies are considered to be the same MA Holder as explained above.   All of these changes should be implemented before notifying MHRA.

• This procedure is known as super-grouping in the EU . UK nationally authorised products cannot be included in super-grouping procedures submitted to the EU

Composite coordination collection (CCC)

For changes to one or more purely national MAs that would affect the product information the Composite Coordination Collection (CCC) procedure can be used. Product information includes the summary of product characteristics, leaflets and labels. https://assets.publishing.service.gov.uk/media/5ff2f52dd3bf7f08a202459b/CCC__updated_guidance__29.12.20.pdf ,

A CCC application can be used to:

• submit only one consolidated mock-up of the leaflets and labels with all the changes proposed.
• submit a mixture of variations applications and Article 61(3) applications
• apply for single or grouped changes, such as a Type IB and/or Type II variations (see groupings)

This scheme should not be used for:

• urgent variations relating to the safety of your product(s)
• standalone Type IA notifications
• changes that don’t affect product information (summary of product characteristics, leaflets, labels)
• changes to a product with a centralised licence

Applicable fees are those that would apply for the changes if applied for as variations and Article 61(3) changes. 

Variations to MAs where Northern Ireland is a Concerned Member State

For NI Only MAs granted through EU MR/DC (mutual recognition/decentralised) procedures, and cases where NI remains a Concerned Member State in a UK-wide MA, variations procedures will be led by the Reference Member State and managed as part of the specific MR procedure.  In those cases EU procedural guidance should be followed:  Heads of Medicines Agencies: Variation  

These MAs can also be included in EU Worksharing procedures (where the same variations are submitted to all involved member states) which will be led by the Reference Authority.  Further guidance can be found in Chapter 7 here: Heads of Medicines Agencies: Variation

• A UK-wide nationally authorised marketing authorisation cannot be submitted as part of an EU Worksharing procedure.

Fees

A full list of fees and further information about fees, can be found in the section fees for licence variation applications. 

The MHRA has also published a fees calculator:  Application Fees Calculator (mhra.gov.uk).  The calculator covers Initial applications (including marketing authorisation, extensions, herbal or homoeopathic applications) and Variation applications and is helpful for highlighting changes that attract a complex fee.

How to apply (all variation types except extensions)

Specific variation changes are given unique change codes to include in the application form.

Check and use the appropriate change code for the specific variation by referring to the annex in the European Commission’s guidelines that needs to be included in the application form:  EUR-Lex - 52025XC05045 - EN - EUR-Lex

For cases where NI remains a Concerned Member State in a UK-wide MA, the variation application can be submitted via the Central European System Platform (CESP). For other variation procedures, the application must be submitted through MHRA Submissions or MHRA Portal. https://www.gov.uk/guidance/mhra-portal-register-to-submit-forms

New marketing authorisation, renewal and variation application submissions must be made using electronic application forms (eAFs). This will apply to all procedure types. If applicants are making a submission using the MHRA Portal, you will have to submit using the portal forms as well as submitting the eAF. If submitting an application through CESP or MHRA Submissions  only the eAF needs to  be submitted.

Applicants must submit variations using the electronic Common Technical Document format (eCTD).

The MHRA checks that eCTD submissions are technically valid using the Lorenz eValidator validation tool. It is recommended that applicants use the same validation tool to check submissions.

ForIf there are any questions about submitting a variation, email variationqueries@mhra.gov.uk.variationqueries@mhra.gov.uk].

For submissions via MHRA Submissions please register.

Submissions through the Common European Submission Portal (CESP)

This system is available from the Heads of Medicines Agencies (HMA) and provides a simple and secure mechanism for exchange of information between applicants and EU regulatory agencies.

The purpose of the system is to:

• provide a secure method of communicating with regulatory agencies via one platform
• allow submission of an application once to reach all required agencies
• reduce the burden for both industry and regulators of submitting/handling applications on CD-ROM and DVD

For applicants who are  first time CESP users and wish to setup up an organisation/university or trust to manage multiple users on the system, register with CESP here.

For applicants who are a standalone users and wish to upload for Non Commercial Use on their own behalf, register with CESP here.

Once registered applicants will receive credentials to access the portal using a registered email address.

General CESP training is available to all registered users via CESP’s training menu once logged into the system. Training on demand videos are available and applicants can also sign up to the MHRA free online weekly live demonstrations. CESP encourage all users to attend training before using the system and view FAQs.

Supporting documents

For CMS submissions applicants should send a dispatch date list (detailing when applicants intend to dispatch the products) to all member states before submitting an application. If an MA was granted through the mutual recognition or decentralised procedures. The list should be emailed to MR-DCprocedures@mhra.gov.uk for Type IB and II changes and include a copy in the ‘additional data’ section of the eCTD format.

Type IA and IB

For Type IA and IB variation applications applicants need to include:

• a cover letter with the MA number, type of variation and reason for the variation
• an explanation of grouped variations if applicable, making specific reference to the Heads of Medicines Agencies (HMA) acceptable groupings guidance and examples of groupings (PDF, 2.5 MB, 12 pages) or the confirmation email from the MHRA agreeing applicants can submit grouped variations
• the supporting information required for specific variations as set out in the annex of the European Commission’s guidelines
• present and proposed details of the product presented as a separate document if necessary
• a contents page listing all documents included in the submission

Type II

For type II applications, applicants must include all of the above and:

• relevant information to support the application such as publications and any cited references
• a new or updated addendum to the ‘quality overall summary’, clinical and non-clinical overviews

Summary of product characteristics (SmPC)

If relevant, the summary of product characteristic fragments (SmPC) should be submitted to the MHRA in the correct format using the templates below. If these templates are not used the submission will be rejected.

These templates should not be altered in any way, other than inserting the relevant information. They should be saved using the following naming conventions in the ‘working documents’ folder of the  eCTD:

m1 -3-1-01: SPC section 1 – product name (MS Word Document, 22 KB)

m1 -3-1-02: SPC section 2 – Qualitative and quantitative composition (MS Word Document, 21.5 KB)

m1 -3-1-03: SPC section 3 - pharmaceutical form (MS Word Document, 19.5 KB)

m1-3-1-4.1: SPC section 4.1 - therapeutic indications (MS Word Document, 19.5 KB)

m1 -3-1-4.2: SPC section 4.2 - posology and administration (MS Word Document, 19.5 KB)

m1 -3-1-4.3: SPC section 4.3 - contra-indications (MS Word Document, 19.5 KB)

m1 -3-1-4.4: SPC section 4.4 - special warnings and precautions (MS Word Document, 19.5 KB)

m1 3-1-4.5: SPC section 4.5 – interaction (MS Word Document, 19.5 KB)

m1 3-1-4.6: SPC section 4.6 - fertility, pregnancy and lactation (MS Word Document, 23.5 KB)

m1 3-1-4.7: SPC section 4.7 - driving and use machines (MS Word Document, 19.5 KB)

m1 3-1-4.8: SPC section 4.8 - undesirable effects (MS Word Document, 19.5 KB)

m1 3-1-4.9: SPC section 4.9 - overdose, emergency and antidotes (MS Word Document, 19.5 KB)

m1 3-1-5.1: SPC section 5.1 – pharmacodynamics (MS Word Document, 19.5 KB)

m1 3-1-5.2: SPC section 5.2 – pharmacokinetics (MS Word Document, 19.5 KB)

m1 3-1-5.3: SPC section 5.3 - preclinical safety (MS Word Document, 19.5 KB)

m1 3-1-6.1: SPC section 6.1 – excipients (MS Word Document, 19.5 KB)

m1 3-1-6.2: SPC section 6.2 – incompatibilities (MS Word Document, 19.5 KB)

m1 3-1-6.3: SPC section 6.3 - shelf life (MS Word Document, 19.5 KB)

m1 3-1-6.4: SPC section 6.4 - special precautions (MS Word Document, 19.5 KB)

m1 3-1-6.5: SPC section 6.5 – container (MS Word Document, 19.5 KB)

m1 3-1-6.6: SPC section 6.6 – disposal (MS Word Document, 19.5 KB)

m1 3-1-07: SPC section 7 - marketing authorisation holder (MS Word Document, 19.5 KB)

m1 3-1-08: SPC section 8 - marketing authorisation number (MS Word Document, 19.5 KB)

m1 3-1-09: SPC section 9 - date of the first authorisation or renewal (MS Word Document, 19.5 KB)

m1 3-1-10: SPC section 10 - date of revision of the text (MS Word Document, 19.5 KB)

m1 3-1-11: SPC section 11 – dosimetry (MS Word Document, 19.5 KB)

m1 3-1-12: SPC section 12 – radiopharmaceuticals (MS Word Document, 19.5 KB)

More information

The European Commission has published guidelines for submitting variation applications including the change codes needed. Applicants may also find the common scenarios for submitting variations (PDF, 171 KB, 7 pages) useful.

The European Commission’s regulation1234/2008 as updated by regulation 712/2012 and Regulation 2024/1701 outlines the legislation for processing variations.

External Publication Examples of groupings for variations October 25 (MS Word Document, 1.15 MB)

10. Marketing Authorisation Variations – Supplementary Guidance October 25 (MS Word Document, 34.541.3 KB)

Contact

Email variationqueries@mhra.gov.uk with any queries, or call 020 3080 7400.

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