Summary of Product Characteristics and product literature for veterinary medicines
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
This guidance applies to applications for national and mutually recognised Marketing Authorisations (MAs) and Veterinary Homeopathic Remedies (VHRs). It does not apply to Centralised applications. VHRs do not have SPCs.
Product Literature Standard
The Product Literature Standard (PLS) is guidance for the production of mock-ups. You must read this before producing and submitting mock-ups for assessment.
Joint assessment of labelling with Ireland
Joint assessment is the term used for a procedure where the Irish National Competent Authority (HPRA) and VMD will collaborate on the assessment of a shared mock-up, for use on veterinary medicines marketed in their countries. Joint assessment is conducted under a G.I.15.z variation (VRA-R).
See Joint labelling for veterinary medicines for use in the UK and Ireland.
National Marketing Authorisations
New MAs
For new GB or NI-national MA applications, you must provide a draft SPC and QRD text with the application in Word format using the
An is available which provides supporting guidance on the information requirements listed.
The SPC and QRD text will be agreed during the assessment phase.
Upon completion of the assessment phase, and subject to your application being approved, the procedure will close and you will be issued an agreed SPC and QRD. Prior to first marketing the product, you are required to submit mock ups via a national G.I.15.z VRA-R to the VMD. You can submit this application either immediately upon close of the new MA procedure, or if not to be marketed immediately, any time before first marketing. Mock-ups should reflect the approved QRD text. Only the smallest pack size that will be marketed is required for assessment.
Existing MAs
For Great Britain, all current MAs are required to update and implement the national QRD v.3 template by 1 April 2029.
For Northern Ireland, EU deadlines for QRD updates apply. Further information is available on EMA website. For nationally authorised products, use the national QRD template.
Mutually recognised Marketing Authorisations
For Mutually recognised MAs, where NI is Concerned Member State (CMS), guidance on QRD templates is available from the EMA website.
New Veterinary Homeopathic Remedies
For new Veterinary Homeopathic Remedies (VHRs), you must provide draft QRD text with the application in Word format using the National SPC/QRD Template. You should delete reference to SPCs as these do not apply to VHRs.
The draft QRD text will be agreed during the assessment phase.
Upon completion of the assessment phase, your application will close and you will need to submit mock-ups for assessment via a G.I.15.z VRA-R.
Mock-up Assessment
Only the mock-ups representing worst case in terms of readability for each label/outer package (usually the smallest pack size) and the package leaflet need to be submitted for approval via a G.I.15.z VRA-R.
Examples include:
- if marketing a new smaller, pack size then the size we have most recently approved, a G.I.15.z VRA-R should be submitted for approval
- if marketing a new larger, approved pack size, a variation is not necessary
- if approval for a new package type has been granted through a separate variation, a subsequent G.I.15.z VRA-R should be submitted to obtain approval for the smallest marketed pack size of that new packaging type
Notifications
Minor mock-up changes that do not affect the font size, layout or legibility, for example a change to the barcode, logo (assuming same size), or removal of non-essential text, may be added to your mock-up without the need for a variation.
See Product Literature Standard (PLS) for more information.
The 2 strikes system
If you are asked to submit revised mock-ups for assessment, you must do so in accordance with the PLS and agreed QRD text.
If mock-ups are not right first time, we will send you comments and ask you to submit revised versions. When we send you our comments, we will say what changes must be made and what changes we suggest you make. If the subsequent re-submitted versions are also incorrect, we will authorise your application with the condition that you must submit mock-ups for assessment under cover of a G.I.15.z VRA-R prior to marketing the product.
Implementation of changes and compliance
Following a variation you have up to 6 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.
This timescale may be shorter or longer depending on the changes involved. The agreed timescale will be stated on your authorisation documentation.
Marketed products must reflect the mock-ups as approved.
Post-authorisation checks
In addition to assessment of mock-ups by variation, the VMD undertake compliance checks of product labelling from the marketplace to ensure compliance with agreed texts. Subject to these findings, you may be asked to submit mock-ups for assessment under cover of a G.I.15.z VRA, which will incur the appropriate fee.
Contact us
By email: postmaster@vmd.gov.uk.
Updates to this page
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Updated to reflect changes to the process for submitting mock up product labelling effective from 02/02/26.
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Updated to reflect changes to the VMR.
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Updated VMD and HPRA guidance and templates on acceptable text for joint-labelled veterinary medicines in the UK and Ireland.
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Updated template references under New MAs and variation-extensions.
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Page updated with new production and submission of SPCs and product literature information
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Amended links to Best Practice Guides on HMA website
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First published.