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.

The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, the Orange Guide is now available through MedicinesComplete.  

The updates incorporate changes made after the UK’s exit from the European Union on the 31 January 2020. Providing 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.

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

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Publication Updates

14 Jun
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The Orange Guide June 2022 Update

The 2022 edition of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The Orange Guide) is now available through MedicinesComplete.

The new edition of the MHRA Orange Guide has been updated to incorporate new European and UK guidance, information and UK legislation relating to the manufacture and distribution of human medicines, active substances, and brokering medicines.

Now in its 11th edition, the Orange Guide has been updated to incorporate changes made after the UK’s exit from the European Union on the 31st January 2020.

Comprehensive new content includes:

  • amended extracts from the Human Medicines Regulations 2012 relating to:
    o manufacture, importation and assembly,
    o wholesale dealing,
    o brokering medicine and
    o manufacturing, importing and distributing active substances.
  • The Code of Practice for Qualified Persons in chapter three, Guidance on Manufacture and Importation.
  • UK guidance on complying with the EU guidelines on Good Distribution Practice for wholesale distributors and brokers of medicines and manufacturers, importers and distributors of active substances.
  • UK guidance on:
    o risk-based inspections,
    o conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and
    o controls on certain medicinal products.

There is also new guidance on:

  • Conditions of holding a manufacturing authorisation for investigational medicinal products,
  • Importing guidance for investigational medicinal products from countries on a list to Great Britain,
  • Pharmaceutical Quality System expectations and Authorisation requirements for investigational medicinal products importation oversight,
  • List of approved countries for import,
  • Pharmacovigilance for wholesalers,
  • The naming of sites on a wholesale dealer’s licence,
  • Self-inspection for wholesale dealers and the responsible person for import.

Plus, revised GMP Annexes 2 and 17, and Commission guidance on principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, for medicinal products for human use and for active substances for medicinal products for human use.

12 Mar
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Orange Guide March 2019 Update

Updates have been made to the Code of Practice for Qualified Persons in chapter three, Guidance on Manufacture and Importation.

11 Dec
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Orange Guide December 2018 update

Updates have been made to the following section of the Rules and Guidance for Pharmaceutical Manufacturers and Distributors:

Chapter 10 – UK Guidance on Wholesale Distribution Practice

Subsection – ‘Short-term Storage of Ambient and Refrigerated Medicinal Products – Requirements for a Wholesale Dealer’s Licence’

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.