Quality

Generic medicines have the same quality, efficacy and safety as the corresponding original or reference product. They are strictly controlled by their manufacturers in their fully equipped laboratories as well as by the relevant state authority. In addition to the tests that they carry out on raw materials, generic manufacturers also evaluate their suppliers to ensure that they too, follow the requirements of Good Manufacturing Practice as stipulated in the relevant European Union Directives.

 

Marketing Authorisation

In order for a pharmaceutical product to be placed on the market, the applicant needs to submit to the relevant state authority, data on its formula, method of manufacture and analysis, clinical data (bioequivalence studies) etc. so that a Marketing Authorisation may be issued. These are renewed in 5 years and the state authorities, both of Cyprus as well as those where the products are exported, carry out inspections to ensure that manufacturers follow the rules on Good Manufacturing Practice and the terms of each Marketing Authorisation.

 

Bioequivalence

An important element of generic pharmaceuticals is their bioequivalence. This term is used when comparing a generic product to the original or reference product, and bioequivalence is when the two products have the same pharmacological action inside the body (in-vivo). This is demonstrated by clinical studies (bioequivalence studies) where (usually) healthy volunteers are administered the two products and then, at pre-determined time intervals, a comparison is made of the drug quantities that have reached the circulation system. Click here for more information.