Rules and Guidance for Pharmaceutical Manufacturers and Distributors (commonly known as the Orange Guide) brings together all the main European and UK directives, regulations and legislation relating to the manufacture and distribution of medicines.

Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK.

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Publication Updates

10 Jul
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Orange Guide July 2018 update

July 2018: Rules and Guidance for Pharmaceutical Manufacturers and Distributors now updated

Update has been made to UK Guidance on Wholesale Distribution Practice – Appointment and Duties of the Responsible Person as well as The Responsible Person Gold Standard.

The section has been updated to incorporate sub-headings and text: Responsible Person, Eligibility requirements, Responsibilities of an RP, Obligations of the Licence Holder, Contract RPs, Small companies, Knowledge requirements, Experience requirements, Assessment of RP knowledge and experience, Reporting arrangements, Deputy RP and delegation of RP activities, Dispute resolution.