Legislation on general medicines aims to ensure the safety, efficacy, and quality of medicines available to the public. Strict market approval processes are important to avoid serious health consequences such as the thalidomide tragedy of the early 1960s, or Vioxx (Rofecoxib) in 2004.
Contributions to Policy Options & Impact Assessment
The legislation on pharmaceuticals dictates the procedures and criteria for granting marketing authorisations for all medicines. It establishes criteria for entry into and retention in the market.
The revision of European legislation on medicinal products for human use (Directive 2001/83/EC) was essential to address the advancements in science and technology and emerging public health threats and ensure that the regulatory framework remains effective, efficient, and capable of safeguarding public health while promoting medical innovation. Revising the legislation was also necessary to harmonise disparities in drug availability and regulatory standards across EU member states, and to facilitate a more consistent and efficient approval process across the European Union.