Regulatory and procedural guidance index

This index of regulatory and procedural guidance provides links to pages listing documents relevant to the operation of the centralised procedure specifically pre- and post-authorisation issues. Each page provides an overview of the key legislative texts, guidelines, procedural advice, templates, SOPs etc. which are available to applicants to guide them through the relevant procedural steps. This index excludes human scientific guidelines as well as general information related to the Agency’s scientific committees. Each page accessible from this page is located in its relevant topic area.

Pages in this index are updated regularly to reflect new or updated guidance documents, and to include documents on new topics.