Pharmacovigilance requirements for parallel distribution and parallel import products


The parallel distribution and parallel import of medicines are legally based on the free movement of goods in the EU internal market. Any administrative measures restricting this fundamental freedom should be as ‘light’ as possible. This is based on the principle of proportionality, as enshrined in European Union law, according to which the administrative measures of an authority cannot exceed what is necessary to achieve the objectives of the treaties.

Furthermore, according to the policy adopted by the European Medicines Agency (EMA), parallel distributors are not marketing authorisation holders and therefore not subject to the obligations of the marketing authorisation holder.

The below clarification addresses the pharmacovigilance obligations with regard to periodic safety update reports (PSURs), additional risk minimisation materials (aRMMs) and direct healthcare professional communications (DHPCs).

About the pharmacovigilance requirements (PSUR, aRMM and DHPC) concerning parallel distribution and parallel import products, clarifications for operators