If you are concerned about fitting the agreed text onto your packaging you must discuss this with the relevant assessor during the assessment phase before the QRD text is agreed. The amount of text included on the QRD must reflect the size of the label. The amount of space you have available on packaging should be considered from the outset and throughout the assessment process. See Summary of Product Characteristics and product literature for veterinary medicines for more information on the application process relating to mock-ups in the UK.
An annotated version of this template ( PDF, 377 KB, 33 pages) is available which provides supporting guidance on the information requirements listed.įor national MAs granted or validated before 28 January 2022, you may continue to use the original national template ( MS Word Document, 58.9 KB).įor mutually recognised MAs you must use the template provided in the Best Practice Guides. For initial GB or NI-national only Marketing Authorisations (MAs) validated on or after 28 January 2022, you must use the revised national SPC/QRD template ( ODT, 40.7 KB).
You must provide draft QRD text using the appropriate template.
#VMD SHIPPING CONTAINER HOMES FULL#
The leaflet that contains information for the user which accompanies the product.Ĭonsists of labelling for the immediate packaging, outer packaging and package leaflet.Ĭontains information on the product as agreed during the course of the assessment.Ī flat artwork design in full colour, presented so that it provides a full-size replica of both the immediate, outer packaging and package leaflet so that the three dimensional presentation of the label text is clear. Information on the immediate or outer packaging. The packaging into which the immediate packaging is placed. The immediate packaging does not include capsules which are administered as part of the product.
The label on the container or any other form of packaging that is in direct contact with the veterinary medicine. See Joint labelling for veterinary medicines for use in the UK and Ireland. To maintain joint labelling the SPC/QRD must remain harmonised. This can be achieved by applying for a harmonisation variation in both countries. To obtain joint labelling, the SPC/QRD must be identical in both the UK and IE. You can apply either at the end of a new MA procedure or retrospectively for existing MAs, whether authorised by EU or national procedures. Joint labelling could be achieved between GB and IE, NI and IE or all 3 - GB, IE and NI. If you are asked to make changes, please make them and do not make any other changes without agreeing it with the relevant authority first.Minor deviations are permitted to correct grammatical errors.Deviating from the above will only be permitted in very exceptional circumstances – it is up to you to agree the wording during the assessment phase of the application procedure and / or before the mock-up review process.If you wish to deviate from the above, contact the relevant authority before submitting mock-ups.Follow the approved QRD text (if available) or the approved SPC (if no QRD) and information in this document.Taking note of the following will greatly enhance your chances of getting your mock-ups right first time: The Product Literature Standard (PLS) should be taken into account when creating mock-ups for assessment.
0 kommentar(er)
