Skip Navigation

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The MHRA Orange Guide)


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

The 2022 edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, known as "The MHRA 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.

Comprehensive new content includes:

  • Amended extracts from the Human Medicines Regulations 2012 relating to:
  • manufacture, importation and assembly
  • wholesale dealing
  • brokering medicine
  • manufacturing, importing and distributing active substances

  • The Code of Practice for Qualified Persons, 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 or active substances
  • UK guidance on: risk-based inspections, conditions of holding a manufacturer’s licence, wholesale dealer’s licence, a broker registration and an active substance registration, and controls on certain medicinal products.

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.

The MHRA Orange Guide is compiled by the Medicines and Healthcare products Regulatory Agency.

The MHRA Orange Guide is also available online at www.medicinescomplete.com

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2022 (The MHRA Orange Guide)

New product

£82.00


RPS MEMBER PRICE £61.50

IN STOCK

  • ISBN 978 0 85711 439 6
  • Published Mar 2022
  • Paperback
    244x172mm (1140pp)

Other titles to consider...

BNF for Children 2022-2023 Paediatric Formulary Committee
Coming soon

BNF for Children 2022-2023

Paediatric Formulary Committee

The BNF for Children is the first choice for concise medicines information for children.

£65.95

RPS Member Price £46.16
Dale and Appelbe's Pharmacy and Medicines Law David H Reissner and Christopher A Langley
 

Dale and Appelbe's Pharmacy and Medicines Law

David H Reissner and Christopher A Langley
Twelfth Edition

The new 12th edition of Dale and Appelbe’s Pharmacy and Medicines Law is your definitive...

£59.00

RPS Member Price £44.25
Rules and Guidance for Pharmaceutical Manufacturers and Distributors Medicines and Healthcare products Regulatory Agency
 

Rules and Guidance for Pharmaceutical Manufacturers and Distributors

Medicines and Healthcare products Regulatory Agency
Online via MedicinesComplete

Now available online via MedicinesComplete, the MHRA Orange Guide is an essential reference for the...

 

More

Twitter News@PharmPress

Twitter LinkedIn

Keep in touch

Follow us on LinkedIn and Twitter for the latest updates at Pharmaceutical Press