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

14 Sep
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Orange Guide September 2018 update 

Updates have been made to the following sections of the EU Guidance on Good Manufacturing Practice, Part 1: Basic Requirements for Medicinal Products:

Annex 17: Real Time Release Testing and Parametric Release

Annex 2: Manufacture of Biological active substances and Medicinal Products for Human Use

Annex 13- Manufacture of Investigational Medicinal Products:

  • Update to Attachment 3: Letterhead of manufacturer
  • Addition of new supplementing guidelines based on the second subparagraph of Article 63(1) of Regulation 2 (EU) No 536/2014 ‘Detailed Commission guidelines on good manufacturing practice for investigational medicinal products for human use, pursuant to the second subparagraph of Article 63(1) of Regulation (EU) No 536/2014.’
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.