The product literature standard (PLS) to be applied when submitting mock-up labelling and product literature for assessment.
Ref: #800202 PDF, 243KB, 21 pages
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Product literature supplied in support of an application for a marketing authorisation to the Veterinary Medicines Directorate must be in accordance with the standard.
Product literature includes:
- the immediate packaging, eg vial
- the outer packaging, eg carton
- the package leaflet, if applicable
The product literature mock-ups must be presented as a flat artwork design in full colour.
Mock-up review process
Mock-ups are assessed against:
- the agreed Quality Review of Documents (QRD) text or, if no QRD, the agreed Summary of Product Characteristics (SPC)
- the PLS
- any other information provided by or discussed with you.
Mock-ups submitted should not deviate from the agreed QRD text and / or SPC.
In exceptional cases, you may be allowed to deviate from the above, but you must contact the relevant authority to discuss this before submitting your mock-ups. Not doing so will delay the approval of your mock-ups, which will then delay issue of the application.
The following are not assessed and should not be submitted with applications:
- shipping packs
- datasheets, including Material Safety DATA Sheets (MSDSs)
- packaging for wholesalers that do not include any labels
- display packaging
- promotional material
Mock-ups will be assessed and signed-off within 20 days of receipt of correct versions. This does not apply for national variations and national renewals, because mock-ups are reviewed during the assessment process.
If the mock-ups contain errors, or are not suitable, you will receive a comments document listing any proposed changes. You should update the mock-ups to incorporate the proposed changes and return revised versions as soon as possible.
You will only receive 1 comments document. If the revised mock ups are still incorrect a condition will be applied to the authorisation to introduce corrected mock ups under the cover of a suitable national variation.
For joint labelled products, the United Kingdom (UK) and Ireland (IE) will agree the proposed changes before sending them to you. Further information about joint labelling is available from VMD and HPRA (IE).
If only minor amendments are needed mock-ups will not be requested, you will be notified of this within 4 days of the procedure ending.
The VMD will issue annotated mock ups when minor changes have been made during a procedure. HPRA will issue the updated QRD with the expectation only those changes will be made to the packaging.
If you do not want to submit mock-ups (for certain pack sizes), or mock-ups are not submitted within the deadlines set, your application can be issued on the condition that mock-ups will be submitted for assessment under cover of a national C.II.6(b) Type IB variation category.
What changes require variations
Any change that may affect the legibility of the mock-up must be approved by way of a variation, for example:
- changes to the colouring of the product literature
- new corporate design of packaging
- new container type / size
- changes to the layout of the package
- introduction of multilingual packs for an already approved authorised product
You should only submit the mock ups for the packaging/labelling that is affected.
If you make any changes to country specific information only, you do not need to submit the variation to the country not affected. Neither country requires copies of revised labels showing changes to the other countries information.
Changes that do not affect the font size, layout or legibility do not require a variation, for example a change to the barcode, logo (assuming same size).
If you submit a revised mock-up showing the proposed change and the VMD/HPRA agrees that no variation is required, we will confirm this with you. This does not mean the VMD/HPRA has assessed or approved the mock-up provided but that the proposed change can be made without the need for a variation. You are not required to submit revised mock-ups to the VMD/HPRA once the change has been made.