§ Mr. Sackville
A product licence in the United Kingdom for a generic medicine is granted on provision of evidence to demonstrate that the product is equivalent to the branded form. Since formulation and manufacturing methods may vary among all the different proprietary and generic forms of a particular medicine, it must be demonstrated that any differences do not produce untoward effects.
The yellow card system for monitoring adverse reactions to drugs is a voluntary system whereby doctors send reports of suspected adverse reactions to the Medicines Control Agency. There have been occasional reports of adverse reactions apparently associated with generic substitution. However, a report of an adverse reaction in association with a drug does not necessarily mean that the drug caused the reaction.