Prozac - No New Data Exclusivity Period for the Liquid Formulation

Originally published March 2005

A generic pharmaceutical company will generally rely on the exemption under Article 10(1)(iii) of Directive 2001/38/EC which provides that the results of full toxicological and pharmacological tests or the results of clinical trials are not required if it can demonstrate that the medicinal product is essentially similar to a medicinal product which has been authorised within the Community for not less than six (or 10) years. The period of protection is known as the data exclusivity period.

The Directive requires further data to be submitted by the innovator companies on variations to their already approved products such as a change of formulation. However, the Directive does not explicitly deal with whether this further data will qualify for its own data exclusivity period.