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 labelling with Ireland
Joint labelling is the term used for a single label/leaflet that has been agreed by Great Britain (GB) and Ireland (IE), or Northern Ireland (UK(NI)) and IE, or all three – GB, UK(NI), and IE for use on veterinary medicines marketed in their countries.
See Joint labelling for veterinary medicines for use in the UK and Ireland.
National only Marketing Authorisations
New MAs and variation-extensions
For new GB or NI-national MA applications validated on or after the 28 January 2022, you must provide a draft SPC and QRD text with the application in Word format using the (v2 updated 13/06/23). An is available which provides supporting guidance on the information requirements listed.
For national GB and/or NI applications validated before 28 January 2022, the remains in effect.
The draft SPC and QRD text will be agreed during the assessment phase.
Upon completion of the assessment phase you will be requested to submit mock-ups reflecting the agreed QRD text which will be assessed during a separate mock-up phase.
Variation applications
For variations to UK wide MAs, GB MAs, national only NI MAs, you must provide a revised SPC and QRD text with the application in Word format. If your initial MA application was validated before the 28 January 2022, you may continue to use the . If your initial MA application was validated after the 28 January 2022, your product information should be presented in accordance with the latest templates referred to under ‘New MAs and variation-extensions’. If there is no previously agreed QRD text you do not need to submit QRD text with your variation application.
You do not need to submit revised SPC or QRD text in support of the changes listed below, unless other changes are applied for at the same time, as we will update the latest authorised version for you:
- Any application run on an administrative timetable
- VNRA (previously referred to as Type IA) change to add/remove/amend local representative details
- VNRA (previously referred to as Type IA) change to the name or address of MA holder
If we have questions about the SPC or QRD text, we will discuss these with you and agree on any changes during the assessment phase – you do not need to re-submit them during this phase. The final agreed SPC and QRD issued to you at the end of the procedure will reflect the agreed wording.
If you wish to make any changes to your mock-ups that are not covered by a specific variation category, such as the removal of obsolete information, which results in layout or formatting changes, please do so under cover of a G.I.15 VRA (previously referred to as C.II.6(b) variation).
Additional guidance for Marketing Authorisations for Parallel Imports
For Marketing Authorisations for Parallel Imports (MAPIs), the draft SPC and QRD text should be based on those of the parent product.
You must also provide:
- copies of the SPC and labelling of the product you intend to import
- samples of both the immediate and secondary packaging as intended for sale on the UK market
MAPIs are subject to the normal labelling requirements as set out in the Product Literature Standard. In addition, the following statements should appear on the outer packaging:
- Manufactured by [name of the MAH of the parent product]
- Procured from within the EU and repackaged by the licence holder [name and address of MAPI holder]
- Adverse events should be reported to the licence holder. To report an adverse event, ring [UK telephone number]
The label should also include the original manufacturer’s batch number and expiry date.
Apart from the product’s authorisation (Vm) number, the product name and the MAH, the details of the MAPI should be identical to the parent product.
Mutually recognised Marketing Authorisations
New MAs and variation-extensions
For new Mutually recognised MAs, where NI is Concerned Member State (CMS), you must provide a draft SPC and QRD text with the application in Word using the template provided in the EMA’s guidance. Version 8.2 should be used for new MA applications validated before the 28 January 2022. Version 9 should be used for new MA applications validated on or after the 28 January 2022.
The draft SPC and QRD text will be agreed during the assessment phase.
Upon completion of the assessment phase you will be requested to submit mock-ups reflecting the agreed QRD text which will be assessed during a separate mock-up phase.
Variation applications
For variations to mutually recognised MAs, where NI is CMS, you must provide a revised SPC and QRD test with the application in Word using the template provided in the EMA’s guidance.
You must submit revised SPCs and QRD text during the assessment phase in accordance with the Best Practice Guides.
You do not need to submit revised SPC or QRD text in support of the changes listed below, unless other changes are applied for at the same time, as we will update the latest authorised version for you:
- Any application run on an administrative timetable
- VNRA (previously referred to as a Type IA) change to add/remove/amend local representative details
- VNRA (previously referred to as a Type IA) change to the name or address of MA holder
If you wish to make any changes to your mock-ups that are not covered by a specific variation category, such as the removal of obsolete information, please do so under cover of a G.I.15 VRA (previously referred to as C.II.6(b) variation)
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 you will be requested to submit mock-ups reflecting the agreed QRD text which will be assessed during a separate mock-up phase.
Revised Mock-Ups
Upon completion of the assessment phase we may ask you to submit revised mock-ups reflecting the agreed QRD text (where applicable) which will be assessed during a separate mock-up phase. We will usually request mock-ups for:
- all new MA and VHR applications
- all variation-extension applications
- variations where the number of changes or Type of change being proposed means it would be easier to see revised mock-ups rather than annotating the changes ourselves. This includes variations that we wouldn’t normally request mock-ups for
- any application on a product where we do not currently hold electronic versions of the mock-ups
If we do not need to see revised mock-ups, we will use the mock-up phase to annotate any agreed changes onto the latest version of the authorised mock-ups and issue these to you.
Mock-ups phase
Only those changes applied for will be reviewed during the mock-ups phase so no other changes may be made or proposed. We retain the right to correct any inaccuracies such as spelling mistakes.
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 C.II.6 (b) variation prior to marketing the product or pack size.
Authorisation documentation
Following approval of an application, we will send you copies of the final agreed versions of the SPC, QRD Text and mock-ups, as applicable.
Non-marketed products or pack sizes
If no mock-ups are provided, or if mock-ups of certain pack sizes aren’t provided, we will authorise your application on the condition that these are submitted (for full or for previously unassessed pack sizes) for assessment under cover of a VRA G.I.15 (previously referred to as C.II.6 (b) variation) prior to marketing the product or pack size.
Implementation of changes and compliance
Following a variation you have 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 form 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 and annotated by us.
Post-authorisation checks
If any information comes to light that casts doubt on the accuracy of the packaging on marketed products, we will ask you to submit mock-ups for assessment under cover of a VRA G.I.15 (previously referred to as a C.II.6(b) variation), which will incur the appropriate fee.
Contact us
By email: postmaster@vmd.gov.uk.
Last updated 13 June 2023 + show all updates
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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.