Veterinary Medicines Directorate
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 manufacturers batch number and expiry date.
Apart from the products 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 EMAs 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