Responsibilities following marketing authorisation

As soon as the MEB has granted a marketing authorisation for a medicinal product, you as the marketing authorisation holder, are responsible for the product's quality, efficacy and safety.

As marketing authorisation holder you are also obliged to have in place the proper pharmacovigilance and risk management systems. You are responsible for:

  • identifying risks
  • continually checking relevant data for pharmacovigilance purposes
  • considering risk minimisation and preventive options
  • taking suitable measures where necessary

Compliance with national and European legislation

As a marketing authorisation holder you are obliged to comply with national and European legislation relating to pharmacovigilance. A few examples of the obligations are:

  • Updating product information on the basis of the latest scientific knowledge
  • Taking suitable measures once new insights become available about the product's efficacy and/or adverse reactions. For example informing authorities and issuing information to health care providers and patients
  • Ensuring that the manufacturing and monitoring methods of the medicinal products are in line with the latest scientific research
  • Ensuring that potential adverse reactions are reported to EudraVigilance. You not only have to report in the case of authorised usage based on normal doses, but also in the event of medication errors and abuse of the product.
  • The submission of Periodic Safety Update Reports (PSURs), if applicable
  • The maintaining of a Pharmacovigilance System Master File (PSMF) and the regular checking of the system for pharmacovigilance
  • The appointment of a person qualified by the EU who is responsible for pharmacovigilance (EU QPPV), and of a national contact person for pharmacovigilance
  • The implementation of a Risk Management Plan (RMP)
  • The submission to the EMA of up-to-date information on all medicinal products for which you have a marketing authorisation within the European Economic Area (also known as the requirements in connection with Art. 57(2) of the XEVMPD).

As far as pharmacovigilance is concerned the Medicines Act [Geneesmiddelenwet] is nationally applicable. In the EU the relevant legislation is laid down in various Regulations and Directives. A number of modules of 'Good Pharmacovigilance Practices (GVP)' have also been drawn up to facilitate the implementation of pharmacovigilance within the EU.

More information about the legislation can be found on the website of the European Commission and on the website of the European Medicines Agency.