FARMA-APS objectives, goals and mission is to develop 10 to 12 new generic molecules per year, duly supported by registration dossiers complying the latest E.U. standards and ICH guidelines.

The Portuguese specific legislation allows us to work on the development and registration of new generic molecules based on 6 years for data exclusivityCurrent legal framework
Under Directive 2001/83/EC, EU data exclusivity laws guarantee market protection for originator medicines for either 6 or 10 years. Data exclusivity extends for six-years after European marketing authorisation is granted in Portugal. Ten-year periods of exclusivity are operated in some major European countries, as example Germany, France, Italy, UK, the Netherlands, Sweden, Belgium, Luxembourg among others., as well as bolar provisionBolar Provision
Some countries permit the manufacturers of generic pharmaceuticals to use the technology of a patented pharmaceutical to perform work that would assist in the marketing or regulatory approval of the generic product, while the patent is in force. This "Bolar" provision then allows the generic producer to market and manufacture their goods as soon as the patent expires. Bolar Provisions have been upheld as conforming to the TRIPS agreement.. This reflects the availability of the registration dossiers at least 7 years ahead within the major European countries.

In FARMA-APS we also work on the so called generic plus, developing added value to the well known molecules, namely working on the development of new galenic formulations, dosages and pharmaceutical forms.