Guidance

Veterinary Medicines: Summary of Product Characteristics and Product Literature

Production and submission of the Summary of Product Characteristics (SPCs) and Product Literature (QRD text and mock-ups).

This guidance applies to applications for marketing authorisations (MA) and veterinary homeopathic remedies (VHR) submitted on a national or EU basis, ie. via the mutual recognition procedure (MRP) or decentralised procedure (DCP). It does not apply to applications dealt with via the centralised procedure.

It only applies to national applications that pass validation on or after 1st April 2016, and to EU applications that haven’t yet completed the assessment phase by this date.

The Product Literature Standard (PLS) has been produced by the VMD (UK) and HPRA (Ireland) to help you in the production of mock-ups. See product literature standard page for more details.

You must read the PLS before producing and submitting mock-ups for assessment.

All MAs have a Summary of Product Characteristics (SPC). VHRs do not have SPCs.

New Marketing Authorisations (MAs)

For applications dealt with on a national basis, you must provide a draft SPC and QRD text with the application. This should be submitted electronically in Word format using the National QRD Combined Template.

For applications dealt with on an EU basis, you must provide a draft SPC and QRD text with the application. This should be submitted electronically in Word using the template provided in the Best Practice Guides.

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; these will be assessed during a separate mock-up phase.

Additional guidance 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 MAPI 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.

New Veterinary Homeopathic Remedies (VHRs)

You must provide draft QRD text with the application. This should be submitted electronically in Word format using the National QRD Combined 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; these will be assessed during a separate mock-up phase.

Variations-Extensions

The submission and assessment of the SPC and QRD text for variation-extensions is the same as for new MAs.

Variations (Type IA, IB and II)

This guidance applies to Type IA, IB and II variations. It does not apply to variation-extensions.

SPCs

You must provide a revised SPC with the application. This should be submitted electronically in Word format.

For applications dealt with on a national basis, you must not submit revised SPCs during the assessment phase. If we have questions about the SPC, we will discuss and agree any changes with you and the final, agreed SPC issued to you at the end of the procedure will reflect the agreed wording.

For applications dealt with on an EU basis, you must submit revised SPCs during the assessment phase in accordance with the guidance provided in the Best Practice Guides.

You do not need to submit a revised SPC in support of the following changes; we will update the latest authorised version for you. This is only applicable if these are the only changes being applied for that affect the SPC.

  • Any application run on an administrative timetable
  • Type IA change to add/delete/amend local representative details; this is done on a national basis regardless of the scope of the product
  • Type IA change to the name and / or address of MA holder on nationally authorised products only

QRD Text

You must provide a revised QRD text with the application. This should be submitted electronically in Word format.

For applications dealt with on a national basis, you must not submit revised QRD text during the assessment phase. If we have questions about the QRD text, we will discuss and agree any changes with you and the final, agreed QRD text issued to you at the end of the procedure will reflect the agreed wording.

The submission of QRD text for nationally authorised products is only applicable where QRD text has already been agreed for that product. If there is no agreed QRD text, do not submit QRD text with your variation application.

For applications dealt with on an EU basis, you must submit revised QRD text during the assessment phase in accordance with the guidance provided in the Best Practice Guides.

You do not need to submit a revised QRD text in support of the following changes; we will update the latest authorised version for you. This is only applicable if these are the only changes being applied for that affect the QRD text.

  • Any application run on an administrative timetable
  • Type IA change to add/delete/amend local representative details; this is done on a national basis regardless of the scope of the product
  • Type IA change to the name and / or address of MA holder on nationally authorised products only

Mock-Ups

Upon completion of the assessment phase you may be asked to submit revised mock-ups reflecting the agreed QRD text (where applicable); these will be assessed during a separate mock-up phase.

Where the submission of revised mock-ups is not considered necessary, we will use the separate mock-up phase to annotate any agreed changes onto the latest version of the authorised mock-ups and issue these to you.

You will never need to submit revised mock-ups in support of the following changes; we will update the latest authorised version for you. This is only applicable if these are the only changes being applied for that affect the mock-ups.

  • Any application run on an administrative timetable
  • Type IA change to add/delete/amend local representative details; this is done on a national basis regardless of the scope of the product
  • Type IA change to the name and / or address of MA holder on nationally authorised products only

What will be assessed

Only those changes applied for will be looked at during assessment; no other changes may be made or proposed. We retain the right to correct any inaccuracies, eg. Spelling mistakes, typos, etc.

If you wish to make any changes to your mock-ups that are not covered by a specific variation category, please do so under cover of a C.II.6(b) category, eg. to remove obsolete information.

Renewals

SPCs

You must provide a revised SPC with the application. This should be submitted electronically in Word format.

For applications dealt with on a national basis, you must not submit revised SPCs during the assessment phase. If we have questions about the SPC, we will discuss and agree any changes with you and the final, agreed SPC issued to you at the end of the procedure will reflect the agreed wording.

For applications dealt with on an EU basis, you must submit revised SPCs during the assessment phase in accordance with the guidance provided in the Best Practice Guides.

QRD Text

You must provide a revised QRD text with the application. This should be submitted electronically in Word format.

For applications dealt with on a national basis, you must not submit revised QRD text during the assessment phase. If we have questions about the QRD text, we will discuss and agree any changes with you and the final, agreed QRD text issued to you at the end of the procedure will reflect the agreed wording.

For applications dealt with on an EU basis, you must submit revised QRD text during the assessment phase in accordance with the guidance provided in the Best Practice Guides.

Mock-Ups

Upon completion of the assessment phase you may be asked to submit revised mock-ups reflecting the agreed QRD text (where applicable); these will be assessed during a separate mock-up phase.

Where the submission of revised mock-ups is not considered necessary, we will use the separate mock-up phase to annotate any agreed changes onto the latest version of the authorised mock-ups and issue these to you.

When will we want to see revised mock-ups

  • For all new MA and VHR applications
  • For all variation-extension applications
  • For renewals and variations where the number* and / or Type of change (PDF, 225KB, 5 pages) being proposed means it would be easier to see revised mock-ups rather than annotating the changes ourselves
  • For any application on a product where we do not currently hold electronic versions of the mock-ups

*If a variation involves changes that we wouldn’t normally request mock-ups for, but there are a lot of those changes being made as part of a grouped or workshare variation, we are likely to request mock-ups.

Non-marketed products / Pack sizes

If no mock-ups are provided, or if mock-ups of certain pack sizes aren’t provided, we will issue your application on the condition that must submit mock-ups (full or for previously unassessed pack sizes) for assessment under cover of a C.II.6 (b) variation prior to marketing the product / pack size.

Authorisation documentation

Following approval of an application, we will send you copies of the final agreed versions of the SPC, QRD Text (if applicable), and mock-ups (if applicable).

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 sending you our comments, we will say what changes must be made, and what changes we suggest you make. If the re-submitted versions are also not correct, we will sign-off your application on QRD text with the condition that you must submit mock-ups for assessment under cover of a C.II.6 (b) variation prior to marketing of the product / pack size.

Compliance

Marketed products must reflect the mock-ups as approved by us; this includes any annotations made to them.

Implementation of changes

Following a variation or renewal application, you have 6 months to implement any agreed changes onto your packaging, ie. anything released by the Qualified Person (QP) must be in the new packaging form the implementation date.

This timescale may be shorted or longer depending on the changes involved. The agreed timescale will be stated on your authorisation documentation.

Post-authorisation checks

If any information comes to light that casts doubt on the accuracy of the packaging on the market, we will ask you to submit mock-ups for assessment under cover of a C.II.6(b) variation, which you will be charged for.

Contact us

By email: postmaster@vmd.defra.gsi.gov.uk.

Published 24 March 2016
Last updated 3 October 2017 + show all updates
  1. Amended links to Best Practice Guides on HMA website
  2. First published.