Spring Intro 2023

Changes requiring professional assessment and approval (2/2)

• P3/P3ex: Changes to pack design and layout. Where these are subject to pre-approval by a third party a 30-day assessment timeframe is offered.

• P4: Changes which are notified to the MAH by the MHRA and for which a full application is solicited. These may include but are not restricted to:

 Approval of artwork for a new own-label supplier not previously reviewed by MHRA  Approval of artwork following a name change, where significant changes are made to the pack design  Introduction of significant new safety information following consideration by an expert advisory committee  Amendment of artwork following a complaint in relation to patient safety

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Notification/self-certification

• Cover letter

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

• Supporting communication (e.g. e-mail or request letter) confirming self-certification route is acceptable, if relevant. Please reference in cover letter and on application form.

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

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