This guidance document addresses a number of questions which stakeholders, in particular the marketing authorisation holders (MAHs)/applicants, may have on an Article 31 non-pharmacovigilance referral procedure.
It provides an overview of the European Medicines Agency’s (the Agency) practical and operational aspects with regards to the handling of Article 31 non-pharmacovigilance referral procedures.
Hyperlinks to the documents, websites or pages listed as reference under specific questions can be found on the page:
Referral procedures: Regulatory and procedural guidance | European Medicines Agency (EMA)