Regulatory Resources


Medicines and medical devices regulation – guidance from 1 January 2021

PAGB has produced detailed guidance for members on what you need to know to prepare for the end of the transition period. Resources include a detailed summary of MHRA ‘standstill’ guidance on regulating medicines and medical devices from 1 January 2021 and a series of decision trees setting out what’s required under different scenarios.

(member log-in required).  Not a member? Find out more about PAGB membership.

PAGB offers member companies advice on all aspects of the current legislation, regulations and guidance at both UK and European level for OTC medicines, food supplements and self-care medical devices.

PAGB is active within the regulatory environment in order to help shape regulatory policy, ensure the views of its member companies are represented in all relevant fora and provide timely updates to its members on important changes to the regulatory environment via email, on our Regulatory Resources pages and via a weekly regulatory intelligence newsletter (member only, contact to subscribe)

Read PAGB’s annual review ‘Leading in a new landscape‘ for more information about PAGB’s regulatory work in 2020.

PAGB members help drive regulatory strategy and activity through membership on PAGB working groups on OTC medicines, self care medical devices and food supplements as well as a number of sub-groups.

Where can I find regulatory information about EU Exit or Covid-19?

Regulatory updates relating to EU Exit/future trade and coronavirus are uploaded to two dedicated blogs in the members area of this site. Access is restricted to PAGB members and associate members only. Members and associate members can also subscribe to our dedicated newsletters to keep you up to date with the latest regulatory news. Visit the EU News blog and the Covid-19 news blog for more information (log-in required).

Read more about PAGB’s position on EU Exit and a future UK-EU economic partnership and about Covid-19 and consumer healthcare (open access).

Regulatory updates (for PAGB members only)

PAGB members can access detailed regulatory intelligence on OTC medicines  self care medical devices and food supplements via the pages below when logged in to this website (registration for PAGB members and associate members only).  This information is also automatically emailed on a weekly basis to PAGB members who subscribe to our Regulatory Intelligence newsletter. Contact for more information about subscribing to this newsletter.

Content posted on these pages includes detailed regulatory information of specific relevance to the consumer healthcare industry such as MHRA guidance, consultations, international developments and updates to relevant legislation, guidance and advice.

Not in membership? Contact to find out more about joining PAGB, the consumer healthcare association. More about membership and eligibility here.

Regulatory consultancy for non-members

PAGB also offers a regulatory consultancy service to companies seeking early advice; for example, on the viability of bringing a product to market, seeking to reclassify a product or exploring claims. Contact us about our regulatory and advertising consultancy services.

OTC Medicines

OTC Medicines

Self Care Medical Devices

Self Care Medical Devices

Food Supplements

Food Supplements