Product Information Templates for Veterinary Medicines (SPC and QRD Text)
Explainer on product information templates to be used by applicants and Marketing Authorisation Holders (MAHs) of veterinary medicines.
Definition of product information and template contents
Product information refers to official documents providing veterinary surgeons and users of a veterinary medicine approved information on how to use a medicine safely and effectively. The product information template consists of the Summary of Product Characteristics (SPC) and labelling and package leaflet text, commonly referred to as the ‘QRD’.
The product information template is a guidance document to help you comply with legal requirements for information to appear on the SPC and labels of veterinary medicines authorised in Great Britain.
The QRD provides the plain text of the minimum information that must appear on the label and package leaflet of the veterinary medicine. Additional information can be included on the labels and package leaflet on the condition this does not contradict or obscure the legibility of the required information. The additional information must not be considered promotional, for example, you cannot refer to company websites. Permitted additional information includes use of symbols to identify products containing anthelmintic substances or controlled drugs, and images in addition to wording provided they are not misleading or cause confusion.
Current template v.3
supports the requirement of the Veterinary Medicines Regulations (VMR) 2013, as anticipated to be amended by the legislation introduced to Parliament on 4 March.
We are introducing the v.3 template prior to the VMR amendments coming in to force to reduce regulatory burden and on the understanding that all affected applications adopting v.3 will be issued after the VMR 2013, as amended is in effect. If there is any delay to the parliamentary process for amending the VMRs, the implementation date referenced in the below section will also be delayed.
An is available, providing supporting guidance on the information required.
Template v.3 contains:
- a new structure of the SPC, labelling and package leaflet with the order of sections in the package leaflet and in the SPC aligned
- simplified outer and immediate labelling requirements, with an emphasis on the importance of reading the package leaflet
- a consolidated section on ‘minimum particulars to appear on small immediate packaging units’, incorporating blisters and strips
- a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines, to promote prudent use of antimicrobials and limit the risk of development of antimicrobial and antiparasitic resistance
- reference to national collection systems for disposal of waste veterinary medicines
Previous templates
For national Marketing Authorisations (MAs) and post authorisation applications granted or validated before 29 April 2024, you may continue to use prior versions of this template, available here:
- For MAs validated before 28 January 2022, the original national product information template (MS Word Document, 58.9 KB).
- For MAs validated after 28 January 2022 but before 29 April 2024, the or national product information template. V.1 was updated on 13 June 2023 to simplify requirements for the outer and immediate labelling.
Implementation date
For initial national MAs validated on or after 29 April 2024, you must submit your proposed product information in accordance with the v.3 template. Your application will be deferred at validation if you submit the incorrect template.
For existing MAs granted prior to this date, from 29 April 2024, you may submit a G.I.18.z Variation Requiring Assessment (VRA) to update your existing product information to the v.3 template. To support management of the timing and volume of these applications, we encourage you to inform the VMD of any submission plans you may have.
Following granting of a G.I.18.z VRA application, you have up to 12 months to implement any agreed changes onto your packaging. This means that products released by the Qualified Person (QP) must be in the new packaging from the implementation date, but before the deadline described in the section below.
Deadline for updating to v.3
A transition period is introduced in the Veterinary Medicine Regulations 2013, as amended, which requires you to update and implement your product information in line with template v.3 by 1 April 2029. For MAs granted under an EU procedure (MRP/DCP/Centralised), where Northern Ireland (NI) is a Concerned Member State, please visit the EMA website for guidance on product information templates and deadlines for implementation of related changes.
Ongoing procedures
For ongoing G.I.18.z VRA applications, you may provide updated product information in compliance with template v.3 as part of your next variation assessment company response submission. If your application has progressed beyond company response period(s), you will need to submit a further G.I.18.z VRA application to update to template v.3 once your current application has been issued.
Grouping of G.I.18.z VRA applications
You can apply to update your product information to template v.3 as part of a grouped application with other VRAs. However, we recommend that you avoid submitting any other variations affecting the SPC/QRD whilst these are running.
We will not accept grouped applications for G.I.18 variations, involving veterinary medicinal products (VMPs) with PI texts that are not identical.
Specific requirements for UK package leaflets
There is no legal requirement to include a ‘date of package leaflet’ on UK veterinary medicine packaging. Therefore, in v.3, section 15 of the package leaflet has been updated to state “PID Link”, providing a standard statement on how to find more product information by searching for the Product Information Database (PID), and guidance on when we require this included. You do not need to print the heading on your package leaflet, and therefore the PID statement can be included, where applicable, under section 15 of your multi-country package leaflet.
This does not prevent you from including a date of your choosing on your printed package leaflet for the UK, however we will not verify this date but consider this as additional information that does not contradict the SPC.
Maintaining UK Marketing Authorisation numbers
For MAs granted prior to 1 January 2021, if you decided to submit a G.I.18.z VRA prior to 29 April 2024, your Vm4000 MA number will have been split into Vm3000 (NI) and Vm5000 (GB) numbers. We are unable to revert to a single Vm4000 number upon updating of your GB product information to template v.3. The two Vm numbers you have been granted will remain in effect and will need to be included on your mock-ups.
If you submit your first (and only) G.I.18.z VRA on or after 29 April 2024, your exiting VM4000 MA number will remain. This is because, subject to arriving at the same assessment outcome, your product information for GB and NI will be harmonised.
However, where necessary we may reach different conclusions to the EU and propose different SPC or QRD wording if it is more appropriate based on conclusions from the assessment of the data provided in support of the application. At the point this is identified, your MA will be split, and you will be issued separate MA numbers for GB and NI. You remain responsible for informing us, at appropriate procedure time points, if you want agreed text from the equivalent EU procedure to be considered for your GB authorisation.
Joint assessment of labels
Joint assessment refers to the procedure where the Irish national competent authority (HPRA) and VMD collaborate on the assessment of a shared mock-up, for use on veterinary medicines marketed in both countries.
In the interest of facilitating joint assessment of labelling, the minimum information required in the v.3 template is closely aligned to the labelling requirements applied to veterinary medicines authorised in Ireland.
For new MA applications, upon completion of the assessment phase, you will be requested to submit mock-ups reflecting the approved QRD text. If you respond to advise joint labelling is required, the new MA procedure will be closed, and you will need to submit G.I.15.z VRAs to both the VMD and HPRA at the same time to facilitate joint assessment of your mock-ups prior to marketing.
If joint labelling is not requested, your new MA procedure will proceed into a national mock-up assessment phase.
For further guidance on how and when to submit mock-ups to the HPRA for assessment, visit the HPRA website.
Contact us
Once you have applied, to discuss specific application points contact the people assigned to the application given in the validation passed email.
For all other enquiries email: [email protected]
Updates to this page
Published 4 April 2024Last updated 7 August 2024 + show all updates
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Text added: We will not accept grouped applications for G.I.18 variations, involving veterinary medicinal products (VMPs) with PI texts that are not identical .
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First published.