Regulatory Roadmap for the development of human medicinal Products (Europe focus)
Just click on the various stages below to reveal the information.
The voluntary, or otherwise, termination of the licence to manufacture and market a particular product;
At the end of the product Life-cycle, i.e. when the product is off-patent and generic competition has eroded product revenue, the product may be removed from sale following withdrawal of the product from the supply chain and termination of all existing Product Licenses.Alternatively, the product may be divested and the product licenses transferred to the new owner of the product.
GMP : Product Manufacturing
Control of Substances Hazardous to Health (COSHH)
Good Clinical Practice
Volume 9A of the Rules Governing Medicinal Products in the EU
Computer Systems Validation
|OUTPUTS||Confirmation of Cancellation of Licence
Agreement of Licence Transfer