Advertising Codes and Guidance
Get access to PAGB’s codes of practice for advertising OTC medicines and medical devices to consumers and professionals, as well as guidance on specific types of advertising to keep your campaigns compliant.
Categories: OTC medicines, self care medical devices, digital, advertising, regulatory
Access: PAGB members and associate members only. Not a member of PAGB? Find out more about membership or our regulatory consultancy services here
With this guidance, we’ll help you understand the definitions and utilisation of Real-World Data (RWD) and Real-World-Evidence (RWE) in the over-the-counter (OTC) sector in the UK, based on the different OTC product lifecycle stages.
We provide answers to questions including:
- What is Real-World Evidence and Real-World Data?
- How can you generate RWE from RWD?
- What are the potential applications of RWE and RWD across the product lifecycle
- What are the key elements of Real-World studies
We’ll also help you identify common elements that need defining while in the early phases of Real-World Evidence / Data project study design.
This guidance is for anyone working within the consumer healthcare industry. It should be read alongside the relevant PAGB Codes of Practice and current regulatory, legal, ethical, and national government policy documents, to ensure that up to date guidance and regulations are followed. This document is provided as guidance only and is not intended to be construed as legal or regulatory advice.
For regulatory advice, contact regulatory@pagb.co.uk
This guidance is available to PAGB members only – please log-in or register
Not a member of PAGB? Find out more about membership or our regulatory consultancy services here
This guidance has been developed by PAGB to provide best practice advice to member companies on formulating advertising claims based on Real-World Data (RWD) and Real-World Evidence (RWE).
It focuses mainly on OTC medicines but the same principles apply to medical devices.
This document is provided as guidance only and is not intended to be construed as legal or regulatory advice. PAGB can provide top level advice on study design and methodology upon request. However, a full review of claims and the supporting evidence can only take place upon the submission of the final claims support document.
For more information on using Real-World Evidence in advertising, contact copyclearance@pagb.co.uk
All advertising and marketing materials must still comply with all relevant regulatory requirements including those set out in the MHRA’s Blue Guide, PAGB Advertising Codes for Medicines, PAGB Medical Devices Consumer Code (MDCC), CAP guidance and current requirements for adverse event reporting.
This guidance is available to PAGB members only – please log-in or register
Not a member of PAGB? Find out more about membership or our regulatory consultancy services here
PAGB’s Codes of Advertising Practice, guidelines and additional guidance are available here. Log in to the members’ area to access the full range of guidance. For more information, contact info@pagb.co.uk. Not a member of PAGB? Find out more about membership or our regulatory consultancy services here
Developed 2020-1
Published July 2021
For more information about this guidance, please contact regulatory@pagb.co.uk