Product Literature Standard (PLS) for veterinary medicines

Guidance for the veterinary pharmaceutical industry on the production of mock-ups for assessment.

The Product Literature Standard (PLS) should be taken into account when creating mock-ups for assessment.

Taking note of the following will greatly enhance your chances of getting your mock-ups right first time:

You must provide draft QRD text using the appropriate template. For new national Marketing Authorisations (MAs) you must use 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.

Updating existing MA to latest templates

For Great Britain, all current MAs are required to update and implement the national QRD v.3 template by 1 April 2029.

For Northern Ireland, EU deadlines for QRD updates apply. Further information is available on the EMA website. For nationally authorised products, use the national QRD template.

The amount of space you have available on packaging should be considered from the outset and throughout the assessment process. The amount of text included on the QRD must reflect the size of the label.

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 following should be taken into consideration during the design of mock-ups.