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.
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 validated on or after the 29 April 2024, 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 you will be requested to submit mock-ups reflecting the approved QRD text which will be assessed during a separate mock-up phase.
Existing MAs
For existing national MAs (GB and NI), your existing approved SPC and QRD will continue to remain valid. You will need to update to v.3 national product information template by 1 April 2029 via a G.I.18.z VRA.
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 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 approval of your application, we will annotate your existing authorised mock-up (where possible) and issue this upon completion of your application. Alternatively, we may ask you to submit mock-ups reflecting the agreed QRD text, which will be assessed during a separate national mock-up phase. We will usually carry out an assessment of mock-ups for:
- all new MA and VHR applications
- variations where the number of changes or Type of change being proposed results in significant change to the mock-ups we have on record
- any application on a product where we do not currently hold electronic versions of the mock-ups
If you wish to make any changes to your mock-ups that are not covered by a specific variation category, such as assessment of a mock-up for an approved pack size for the first time, please do so under cover of a G.I.15.z VRA.
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 via a notification.
See Product Literature Standard (PLS) for more information.
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 variation G.I.15.z VRA prior to marketing the product or pack size.
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 assessment under cover of a G.I.15.z VRA prior to marketing the product or pack size.
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
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 G.I.15.z VRA, which will incur the appropriate fee.
Contact us
By email: [email protected].
Updates to this page
Published 24 March 2016Last updated 29 April 2024 + show all updates
-
Updated to reflect changes to the VMR.
-
Updated VMD and HPRA guidance and templates on acceptable text for joint-labelled veterinary medicines in the UK and Ireland.
-
Updated template references under New MAs and variation-extensions.
-
Page updated with new production and submission of SPCs and product literature information
-
Amended links to Best Practice Guides on HMA website
-
First published.