Module 6

03/10/2024

UK Situation

• UK legislation provides the outline of requirements

• MHRA issues a Blue Guide on Advertising and Promotion

• Acts on behalf of health ministers

• Acknowledges long-established self-regulation supported by statutory role of MHRA • MHRA may investigate cases directly or refer to other bodies e.g. PMCPA, PAGB etc

The Organisation for Professionals in Regulatory Affairs

PMCPA - Prescription Medicines Code of Practice Authority PAGB – Proprietary Association of Great Britain (OTCs, food supplements)

9

UK Situation

• PMCPA provides a more in-depth Code of Practice

• Appointed by and reports to ABPI Board

• Code introduced in 1958

• Reflects and extends beyond the EFPIA Code

• Non-ABPI member companies can/typically agree to adhere to Code

• 2024 update just published

ABPI - Association British Pharmaceutical Industry PMCPA - Prescription Medicines Code of Practice Authority

10

The Organisation for Professionals in Regulatory Affairs

10

5