Pack design pre-vetting service
Pre-vetting service as part of MHRA’s expedited P3Ex assessment procedure for medicinal products.
Free for products in membership - it's a benefit of being a member.
PAGB members have exclusive access to additional advertising and regulatory guidance, which will display on this page when logged-in to this site.
PAGB’s Codes of Practice for the Advertising of OTC Medicines and Medical Devices, and PAGB’s Guideline on the marketing and advertising of food supplements, are available for anyone to view and download above. PAGB publishes additional advertising guidance and materials for members to explain particular areas of the Codes, and to support members on topics including top parity claims; social media; the use of influencers; commercial promotions; specific guidance for advertising related to food supplements; and much more.
For regulatory intelligence updates relating to OTC medicines, medical devices and food supplements, including guidance from external stakeholders and regulators, navigate via the regulatory resources menu above. (member only)
This additional guidance is available to access on this page when logged-in to the site via the members’ area. Registration for the site is for PAGB members and associate members only.
Not in membership? Contact membership@pagb.co.uk to find out more about joining PAGB, the consumer healthcare association. More about membership and eligibility here. Speak to us about our regulatory consultancy service for non-members. Contact membership@pagb.co.uk
In order to support its members in complying with the legal requirements for OTC medicines, food supplements and medical devices, PAGB publishes both formal codes of practice and supplementary guidance documents.
All PAGB codes and guidance reflect the law and, in some areas, they go beyond the law to provide a further interpretation. It is a condition of membership that companies comply with relevant codes and guidance in both the letter and the spirit.
GLOSSARY: What’s the difference between a code, a guideline, guidance and advice?
PAGB operates a pre-publication approval system for member companies’ consumer advertising. It is a condition of membership that all OTC medicines advertising aimed at consumers must be submitted to PAGB for screening and PAGB approval has been given prior to its release into the public domain.
Whilst member companies are legally responsible for their advertising, the pre-publication approval system aims to help members ensure that their consumer advertising complies with the legal and self-regulatory requirements and that the messages portrayed are legal, decent, truthful, balanced, and responsible.
PAGB offers advice on advertising that is aimed at health care professionals but does not operate a system of pre-publication approval for such materials.
In addition to PAGB’s codes and guidance, the Medicines and Healthcare products Regulatory Agency, MHRA, also provides detailed guidance on:
For medical device products to be within scope of PAGB membership they must;
For more information on which devices fall into scope of PAGB membership please contact regulatory@pagb.co.uk
Pre-vetting service as part of MHRA’s expedited P3Ex assessment procedure for medicinal products.
Free for products in membership - it's a benefit of being a member.
Understand how to apply PAGB codes and guidance to your campaigns.
This additional guidance is available to access on this page when logged-in to the site via the members’ area. Registration for the site is for PAGB members and associate members only.
Not in membership? Contact membership@pagb.co.uk to find out more about joining PAGB, the consumer healthcare association. More about membership and eligibility here. Speak to us about our regulatory consultancy service for non-members. Contact membership@pagb.co.uk
PAGB has published a new set of guidance documents to support companies on eCommerce; Real-World Evidence/ Data; and apps and medical devices. This is completely new guidance and PAGB is leading the way in this area. The guidance was developed as part of a strategic digital programme with contributions from PAGB members, associate members and external partners.
PAGB’s digital guidance establishes industry positions on new areas for consumer healthcare including: who is in control of content for eCommerce; the potential for Real-World Evidence and data across the product lifecycle; and the regulatory requirements relating to software medical devices. Click on the images below to access the guidance.
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