European Medicines Agency (EMA) publications and assessment reports
The HPV vaccine was first authorised by the European Commission to be placed on the market for use across the European Union (EU) in 2006. To be granted authorisation, the company responsible for marketing the HPV vaccines (Gardasil, Gardasil 9, and Cervarix) had to provide evidence that the vaccines met clear and predefined standards of quality, safety and efficacy. Further information regarding the authorisation process, steps taken before and after authorisation and the outcome of ongoing monitoring and other regulatory activities for these vaccines is available from the website of the European Medicines Agency at the links below:
Information regarding suspected side effects for all vaccines and medicines is also available to the public via the European Database for Suspected Adverse Drug Reaction Reports, known as EudraVigilance.