The latest UK pharmaceutical regulations, EU directives and guidance for manufacturers and distributors of human medicines, known as the Orange and Green Guides, compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), are available to buy now. These are an essential purchase for anyone subject to good manufacturing practice (GMP) and good distribution practice (GDP) in Europe.

The Orange Guide (Rules and Guidance for Pharmaceutical Manufacturers and Distributors) contains information and legislation relating to the manufacture and distribution of human medicines. The Green Guide  (Rules and Guidance for Pharmaceutical Distributors) provides information on the broader distribution.

Mark Birse, MHRA GMDP Group Manager, IE&S said: “The Orange and  Green Guides are essential tools in helping companies understand the regulatory environment in which they operate, follow good practice and stay compliant with the law.

“This is key to ensuring that safe and high quality medicines for people are being made and distributed, providing the trust needed by patients and healthcare professionals to use them.”

There are new sections on:

  • MHRA Innovation Office
  • MHRA Compliance Management and Inspection Action Group
  • MHRA’s risk-based inspection programme naming contract quality control laboratories on a manufacturer’s licence
  • the gold standard for Responsible Persons
  • the application and inspection process for new licences – what to expect

The new Green Guide has been updated to incorporate the revised EU guidelines on GDP. In addition there are new sections on:

  • GDP quality systems
  • the European Commission Q&A on GDP guidelines
  • the gold standard for Responsible Persons
  • a list of persons who can be supplied with medicines by way of wholesale dealing (Human Medicines Regulations 2012)
  • controls on certain medicinal products
  • Compliance Management and Inspection Action Group
  • the application and inspection process for new licences – what to expect
  • sales representative samples
  • handling returns of non-defective medicinal products
  • MHRA’s risk-based inspection programme
  • reporting adverse reactions
  • short-term storage of ambient and refrigerated medicinal products – requirements for a wholesale dealers authorisation
  • MHRA Innovation Office

Both publications provide a new flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances (ASs) to be used in the manufacture of licensed human medicines.

 

Posted on the UK MHRA website on 6 January 2015