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Guideline on Summary of Product Characteristics (SmPC)
, Notice to Applicants, September 2009
Product-information annotated template
, Quality Review of Documents (QRD), February 2021
EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use
European Parliament: Committee on the Environment, Public Health and Food Safety
SPOR (Substance, product, organisation and referential)