The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as 'The Orange Guide', is the essential reference for all manufacturers and distributors of medicines in the UK.It provides you with a single authoritative source of European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.The new 11th edition has been updated to incorporate changes made after the UK's exit from the European Union on the 31st January 2020