What is a generic medicine?
A generic medicine is a medicine that is similar to an original brand medicine. It has the same active ingredient as the original medicine and is made to the same standard to make sure it is safe and effective.
How do generic medicines become available?
When a pharmaceutical company develops a new original medicine, it takes out a patent. The patent is a legal agreement that prevents other companies from making or selling the same medicine for a number of years.
The new medicine usually has a unique name or brand. It can also be called a "proprietary", a "reference" or an "originator" medicine. When a patent’s time period comes to an end other pharmaceutical companies can make a similar version i.e. a generic of the original version.
Why are generic medicines used?
Generic medicines can save money for patients and the health service.
Generic medicines usually cost less than the original branded product. This is because manufacturers do not need to invest as much money in research, development and marketing as they would if they were producing an original medicine from scratch.
How is a generic medicine different from an original medicine?
Generic versions of a medicine may have different colours, flavours or combinations of non-active ingredients (for example colourings, starches, sugars) compared to the original product.
A generic medicine may also be a different shape or size and come in a different box, packet or bottle.
None of these differences affect the way the medicine works.
Are generic medicines safe and effective?
Yes. A generic medicine must meet exactly the same standards of quality and safety and have the same effect as the original medicine.
They must be authorized by the regulator and they must have the same intended effect on the body as the original product.
What does "Good Manufacturing Practices" (GMP) mean?
GMP is a regulatory guideline imposed on all manufacturers of pharmaceuticals in order to ensure compliance with quality standards such as the pharmacopeia standards, the marketing authorization and other applicable regulatory requirements in order to ensure the quality, efficacy and safety of pharmaceuticals.
Source:"Our advice on Generic Medicines", Irish Medicines Board