Regulatory about cosmetic ingredients

Many of the ingredients used in the cosmetic products are actually industrial strength chemicals, solvents and petroleum by-products. This is even true for many of the most expensive products available and products being promoted as "natural". The truth is that many of the ingredients used widely by cosmetic industry , reason of being used is not that  they are good for your skin.

Readability (QRD) Testing of Patinet Information Leaflet (PIL)

Since 2005, marketing authorization holders of medicines are required to have the patient information leafets for their products readability tested. The European Directive 2004/27/EC (a revision of Directive 2001/83/EC) defines it as follows: 'The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use' .

New legal framework for harmonisation of the data exclusivity

The new periods of data exclusivity will only take effect for reference products applying for marketing authorisation after the new law is fully in effect (around November 2005). Therefore, the first generics applications under the 8+2+1-year data exclusivity period will not occur until late 2013.