Are you involved in the manufacturing or the distribution of medicinal products? Have you bought your Orange or Green Guide yet?
The 2015 edition has been released on general sale. The guides are produced by the MHRA to provide the rules and guidance for your pharma business. The Orange Guide covers the legislation and information regarding manufacturing and distribution of human medicinal products. The Green Guide is for wholesale distributors. Both guides now contain a process flow diagram of the registration procedure.
The guides are essential tools for any manufacturer or distributor looking to operate within this regulated field. Ensuring that medicines are produced and distributed in a safe and compliant manner.
The Orange guide contains new sections on:
- The Innovation Office
- The Compliance Management and Inspection Action Group
- The risk-based inspection programme adopted by the MHRA
- The Gold Standard for Responsible Person produced by Cogent
- The application and inspection process for new licences
The Green Guide contains new sections on:
- GDP quality systems
- Q&A on GDP guidelines from the European Commission
- The Gold Standard for Responsible Person produced by Cogent
- Who can be supplied medicines via wholesale distribution
- Certain medicinal products Controls
- The Compliance Management and Inspection Action Group
- The application and inspection process for new licences
- Samples carried by Sales Representatives
- Returns of non-defective medicinal products
- Risk-based inspection programme
- Adverse reaction reporting
- Logistics of ambient and refrigerated medicinal products – short term storage and circumstances warranting a WDA(H)
- The Innovation Office
If you haven’t got your copy contact us for more information of where you can purchase a copy
Kim Peck