Do generic medicines companies have access to the data of originator products?
No. Generic medicines applications do not make use of any data from the originator registration file. In fact, the data of originator products are never revealed to third parties, and so cannot be used by generic medicines researchers. Instead, generic medicines producers research and develop their own formulation of the product which must then be approved under the same EU requirements as originals. Since generic medicinal products contain well-known, safe and effective substances, the pre-clinical tests and clinical trials performed by the originator are not repeated. Indeed, it would be unethical and contrary to international convention to do so. The safety and efficacy of a generic product is cross referenced with the originator product’s dossier by the medicines authorities who alone have access to these files.
