Spring Intro 2023

Submission for full assessment

• Cover letter

• Application form (word version as shown or pdf form via the portal)

• Reason comments including category for submission (more than one may apply). Please ensure that if the submission is for expedited review under the P3Ex category, this is stated in the cover letter and on the application form.

• Clean consolidated update labelling and/or leaflet mock-ups

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Mock-ups

• A mock-up is a copy of the flat artwork design in full colour, presented so that, following cutting and folding where necessary, it provides a replica of both the outer and immediate packaging so that the three-dimensional presentation of the labelling text is clear.

• Labelling mock-up must be consolidated – i.e. include all outer and immediate packaging elements regardless of whether they have been updated or not.

• Please ensure that that for the leaflet, printers grids or any personal details are removed from the pdf file submitted. Remember – these are published on the MHRA website.

• Mock-ups should represent the relevant components at 100% and should not contain unnecessary technical layers.

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