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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

TheProduct 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.

SeeJoint labelling for veterinary medicines for use in the UK and Ireland.

National Marketing Authorisations

New MAs

For new GB or NI-nationalMAapplications validated on or after the 29 April 2024, you must provide a draftSPCandQRDtext with the application in Word format using the national product information template (MS Word Document, 85.7 KB)

An annotated version of this template (PDF, 444 KB, 36 pages)is available which provides supporting guidance on the information requirements listed.

The SPCandQRDtext will be agreed during the assessment phase.

Upon completion of the assessment phase you will be requested to submit mock-ups reflecting the approvedQRDtext 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 theEMA website.

New Veterinary Homeopathic Remedies

For new Veterinary Homeopathic Remedies (VHRs), you must provide draftQRDtext with the application in Word format using the NationalSPC/QRDTemplate. You should delete reference to SPCs as these do not apply to VHRs.

The draftQRDtext will be agreed during the assessment phase.

Upon completion of the assessment phase you will be requested to submit mock-ups reflecting the agreedQRDtext 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 agreedQRDtext, which will be assessed during a separate national mock-up phase. We will usually carry out an assessment of mock-ups for:

• all newMAandVHRapplications
• 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 thePLSand agreedQRDtext.

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 arent 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:postmaster@vmd.gov.uk.