Module 6

03/10/2024

Complaints Procedure

As part of 2024 update, an abbreviated procedure is now available

The Organisation for Professionals in Regulatory Affairs

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MHRA Vetting of Promotional Materials

• MHRA may request companies to submit their initial promotional and non-promotional materials for MHRA review • NCEs, POM to P switches, company has previously breached regulations • If company has not received a request, contact MHRA in advance of MA if quick launch planned • Communicate timings, type of materials, audience • Non-promotional materials include press releases, advisory boards, non-promotional meetings

• Vetting period typically 1-3 months, not exceed 6 months

The Organisation for Professionals in Regulatory Affairs

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