cmdh variation cover letter template

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• Health and social care
• Medicines, medical devices
• Marketing authorisations, variations and licensing guidance

Medicines: apply for a variation to your marketing authorisation

Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.

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
• a change to the safety, efficacy or pharmacovigilance of the product

Changes are classed as major (type II) or minor. Minor changes are either type 1A or 1B.

You can apply for:

• a single change to one marketing authorisation (MA)
• multiple changes to one or more products and/or MAs

Marketing Authorisation Types

From 1 January 2021, the following Market Authorisation types will be possible in the United Kingdom (UK):

( Guidance relating to application for a licence to market a medicine in the UK )

PL – authorised for use in United Kingdom

• as a purely national UK wide MA
• as part of an MR/DC procedure involving Northern Ireland as CMS, but a UK wide MA

PLGB – authorised for use in Great Britain only (England, Scotland and Wales)

• as a purely Great Britain national
• following conversion of a centrally authorised product (CAP)
• under the unfettered access route (MAH needs to be established in Northern Ireland and any product must access Great Britain, via Northern Ireland as a qualifying Northern Ireland good).

PLNI - authorised for use in Northern Ireland only

• as a purely Northern Ireland national
• as part of an MR/DC procedure including Northern Ireland only

Variations procedures

The variation procedures which will be followed for the different types of Marketing Authorisations from 1 January 2021 are essentially the same as before that date, where relevant, covered by the appropriate European or National legislation. The procedures are dependent on who is responsible for leading the assessment i.e. MHRA for purely national variations, the RMS for MR/DC or Reference Authority for any worksharing variations.

Centralised Marketing Authorisations are authorised for use in Northern Ireland only and any variations to these products will be managed by the EMA.

Until further notice the variations classification guideline , which is a fundamental component of the operation of the variations system, will continue to apply to all types of variations.

Reliance Route

Variations to purely national MAs (PL, PLGB and PLNI) can be presented to the MHRA under the reliance route i.e. following the acceptance of the same change(s) to a related the same product as part of a European procedure e.g. a CAP variation or an MR/DC variation.

If this approach is to be followed, this needs to be made clear in the application and relevant evidence, declarations and supporting information e.g. where relevant, copies of assessment reports should be provided to support the submission. Further guidance will be issued in due course.

Minor variations

These are divided into 2 types: IA and IB.

Type IA change

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 details of where the product is packaged

Type IA procedures are classed ‘do-and-tell’, where you should implement the change before you notify MHRA, ensuring that where relevant (non-immediate notification) you submit the application within 12 months. If the implementation period passes 12 months without a variation being made, a default Type 1B should be submitted. The MHRA will take up to 30 days to process your application.

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

Type IAIN change (immediate notification)

Type IAIN is a sub-type of type IA and also classed a ‘do-and-tell’ procedure where MHRA requires ‘immediate notification’, within 2 weeks of the change being implemented. A minor change would usually be type IAIN if it interferes with MHRA’s ability to continuously supervise the product.

All relevant conditions and documentation must be met for a Type IA/IAIN and confirmed in a copy of the classification guideline with either a tick or where not relevant, Not Applicable (N/A).

No ‘requests for further information’ (RFI’s) apply to Type IA procedures and there is no fee associated with a National Type IA/IAIN. A full fees list and further information about fees, can be found in the section fees for licence variation applications.

Type IB change

If the change is more significant than a IA change but is not a type II change or an extension, it is considered a type IB change. MHRA must approve type IB changes before they are made to the product.

Once MHRA has all the necessary documents, it takes up to 30 days to process your initial application. You could be given a further 30 days to respond to any requests for information letter, which for Type IB are referred to as Notification with Grounds letters (NWG).

These are seen as a conditional determination of a type IB variation, where the applicant has one opportunity to address any deficiencies or omissions.

There is a 30-day deadline to respond to a NWG otherwise the variation will be withdrawn or 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 may have a significant impact on the quality, safety and/or efficacy of the product.

MHRA needs to approve major variations before they are made. One example of a major change is adding a new therapeutic indication to a product or updating the current indication (the medical needs the product is used for).

Once MHRA has all the documents, it will take 30, 90 or 120 days to assess your application depending on how urgent or complex the changes are, excluding time taken to answer questions.

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 your application depending on how urgent or complex the changes are, excluding time taken to answer questions.

With questions (RFIs), assessment timeframes become 30, 90 and 120 days respectively.

The below tabulates the various stages for each type II timetable

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 [email protected]

All other forms of submission will be rejected.

Common invalidation errors and pre-submission checklist

Following analysis of submissions MHRA has developed a pre-submission checklist of submission errors. Applicants are strongly advised to use the pre-submission checklist below which will reduce the likelihood of the submitted application being invalidated or rejected.

See our pre-submission checklist (PDF, 26.9KB, 2 pages

The marketing authorisation holder (MAH) is responsible for ensuring that, where relevant, 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.

Although extensions are still considered a type of variation, their impact on a product is so significant that you will need to follow the application process to apply for a new MA . The form for this process has a section on extensions.

Extensions can be:

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

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

Revised labels, leaflets and/or packaging

If your variation (eg change of manufacturer) affects details of the labels, leaflets and or packaging (also known as livery) of the product, you will need to include the updated versions with your submission to be assessed.

However, you don’t need to submit a variation if there hasn’t been change to the product and you only want to make style changes to the labels, leaflets and/or packaging.

For example, if you’re changing the design of the leaflet and it has no relation to a change in the product, a variation application is not needed. See patient information leaflets for guidance on how to submit these types of changes.

Submit grouped changes (grouping)

You can apply multiple changes to a single product using the ‘grouping’ format, as long as the changes are directly related.

For example, you can make a change to the manufacturing site of the finished product, change in batch size and the manufacturing process to 1 product. The type of procedure (type IA, IB, II) depends on the extent of the change. You can see details of this in the annex III of the variations Regulation and Schedule 10A of the Human Medicines Regulations.

You can submit grouped changes to an MA with multiple product licences under the European procedure.

If a type IA variation is included in a group with other types of variations, the type IA change should not be implemented until all changes for that group have been approved.

You can group any type IA and IAIN changes for different marketing authorisations, as long as the group only contains IA and IAIN changes and the changes are the same. All of these changes should be implemented before you notify MHRA.

Grouping applications for national MAs

For groupings where MAs were granted in the UK through a national procedure only, you will need to apply for grouped changes through the MHRA.

Check the acceptable grouping guidance and the examples of groupings ( PDF , 2.5 MB , 12 pages ) to see if your grouping is acceptable.

If your desired group of changes isn’t included in the guidance or the examples, you need to complete the grouping template , copy and paste it into the main body of an email and send it to [email protected] before you submit your application. We aim to confirm if your grouping is acceptable within 7 working days.

Variations to multiple products (worksharing)

In some circumstances, you can use the worksharing format if you’re submitting the same type IB or type II change or group of changes to multiple MAs. As far as any product which is authorised in the UK is concerned only products which are authorised in Northern Ireland either centrally, purely nationally in Northern Ireland only, or as part of an MR/DC procedure can be the subject of worksharing. Proposals for worksharing applications should be sent to:

• the European Medicines Agency (EMA) if any of the MAs you want to change were granted under the centralised procedure
• the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh) if the MAs were granted under the mutual recognition and/or decentralised procedures and the reference member states were different *the reference member state if the authorisations were granted under the mutual recognition and/or decentralised procedure and the reference member state is was the same for each MA
• the competent authorities for the relevant countries if the MAs were granted under purely national procedures, email [email protected] for the UK.

Once MHRA have all the necessary documents, it will usually take 60 days to assess applications although it could take up to 120 days if the variation(s) are more complex or up to 30 days if urgent.

See the best practice guide on worksharing for details on how to submit an application this way.

Composite coordination collection (CCC)

If you want to apply for changes to one or more product licences (licence for each product under a marketing authorisation) that would affect the product information you can submit a composite coordination collection (CCC). Product information includes the summary of product characteristics, leaflets and labels.

With a CCC you can:

• 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 )

You shouldn’t use this scheme 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

You would pay for this scheme as though you were paying for individual variations. See the list of fees

To get your CCC proposal approved and to see how to apply, follow the guidance for CCC application ( PDF , 538 KB , 32 pages ) .

Fees for variations .

Use the Fees Calculator to work out what the fee for your submission will be.

How to apply (all variation types except extensions)

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

Match the right change code to your specific variation by checking the annex in the [European Commission’s guidelines](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52013XC0802(04). You will need to include this in your application form.

Submit the variation application form ( MS Word Document , 970 KB ) along with the supporting documents via the MHRA Portal

You can now submit your application via the Central European System Platform (CESP) .

Since January 2016 it has become mandatory for new marketing authorisation, renewal and variation application submissions to be made using electronic application forms (eAFs) . This will apply to all procedure types, including national procedures. If you are making a submission using the portal, you will have to submit using the portal forms as well as submitting the eAF. If you are submitting your application through CESP or MHRA Submissions you will only need to submit the eAF.

You must submit your variation using the electronic Common Technical Document (eCTD) .

We check that eCTD submissions are technically valid using the Extedo Eurs is Yours (EiY) validation tool. We recommend that you use a validation tool to check your submission.

If you have any questions about submitting your variation, email <[email protected]]>.

For submissions via MHRA Submissions please register .

You should use our eAF and cover letter tool to determine what information you need to include in your application. If you do not include the correct information your application will not be validated.

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 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

If you are a first time CESP user and wish to setup up an organisation/university or trust to manage multiple users on the system, register with CESP here .

If you are a standalone user and wish to upload for Non Commercial Use on your own behalf, register with CESP here .

Once registered you will receive credentials to access the portal to your 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 you can also sign up to our free online weekly live demonstrations. CESP encourage all users to attend training before using the system. View FAQs .

Supporting documents

For CMS submissions send a dispatch date list (detailing when you intend to dispatch the products) to all member states before submitting your application if your MA was granted through the mutual recognition or decentralised procedures. The list should be emailed to [email protected] 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 you need to include:

• a cover letter with your MA number, type of variation and reason for the variation
• an explanation of your 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 MHRA agreeing you 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 your product presented as a separate document if necessary
• a contents page listing all documents included in your submission

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

• relevant information to support your 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 (SPC)

If relevant, the summary of product characteristic fragments (SPC) should be submitted to MHRA in the correct format using the templates below. If you do not use these templates your 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 ‘workingdocuments’ folder of your 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. You 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 outlines the legislation for processing variations.

Email [email protected] with any queries, or call 020 3080 7400.

Added link to Fees Calculator.

Following the end of the transition period, published new information on marketing authorisation types.

Updated Group Template

Inserted new text/section - Request for Information (RFI)

Updated links to Variations and CCC calculators.

Updated guidance for CCC application.

Links have been updated.

Added a calculator to work out what the fee for your CCC submission will be.

New email address for Area 3 submission queries

Link to variation fees calculator added to the page

Updated pre-submission checklist

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• > Human Medicines
• > Procedural Guidance
• > Application for MA

Application for Marketing Authorisation ( MA )

In order to view some of the documents on this website you need Acrobat Reader (click here to download)

• Best Practice Guide for the Decentralised and Mutual Recognition Procedures    (April 2022) [ Track version ]
• Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures  (September 2020) [ Track version ]
• Best Practice Guide on Break-out Sessions/Hearings  (April 2016) [ Track version ]
• Best Practice Guide for authorisation of non-prescription medicines in the Decentralised and Mutual Recognition procedures   (April 2022) [ Track version ]
• Recommendations on Informed Consent Applications in Mutual Recognition and Decentralised Procedures  (March 2023) [ Track version ]
• Recommendations on Multiple/Duplicate Applications in Mutual Recognition and Decentralised Procedures   (May 2016) [ Track version ]
• MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures (September 2020) [ Track version ]
• Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP  (December 2022) [ Track version ]
• CMDh Guidance Document for Submission of Summary of the Pharmacovigilance System  (May 2023) [ Track version ]
• Requirements on Submissions for New Marketing Authorisation Applications within MRP, DCP and National Procedures
• Languages to be used for Marketing Authorisation Applications (MAAs), Variations and Renewals - National, Mutual Recognition and Decentralised applications (December 2020) [ Track version ]
• Mock-ups, Specimens and Samples for new applications  (December 2020) [ Track version ]
• 'Blue-box' requirements    (May 2023) [ Track version ]
• CMDh SOP on decision-making process for new active substance status or extension of marketing protection or data exclusivity [ Track version ](June 2023)
• User Guide for the electronic Application Form for a Marketing Authorisation  (September 2023) [ Track Version ]
• CMDh Best Practice Guide on Multilingual Packaging   (February 2024) [ Tracked version ]

Validation Procedure

• Procedural advice on Validation of MR/Repeat-use/DC Procedures   (July 2022) [ Track version ]
• Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers   (April 2021) [ Track version ]
• Member States Recommendations on the Cover Letter for New Applications submitted through MRP/DCP  (January 2018) [ Track version ]
• CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures  (September 2022) [ Track version ]
• CMS Validation Checklist for human medicinal products in DCP   (July 2022) 
• RMS Validation Checklist for human medicinal products in DCP   (September 2022) 
• CMS validation checklist in MRP   (May 2023)

Introduction to Published Papers on Validation has been taken off the website as it was considered to be obsolete.

• Cover letter for new applications in MRP/DCP

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