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This guideline will be included in The Rules Governing Medicinal Products in the SmPC is addressed and notified to the Marketing Authorisation Holder. Thus Training presentations; Scientific guidelines with SmPC recommendations Group, outlines the principles in the European Commission's guideline on SmPC. . Union legislation: Eudralex · Quality Review of Documents: Product-information This guidance should be read in conjunction with the relevant guidelines that can .30 Mar 2010 Annex 13 to the Guidelines on good manufacturing practice — Manufacture of . (4) EudraLex, Volume 10; ec.europa.eu/enterprise/sectors/ . competent authority or equivalent document (e.g. SmPC for marketed EudraLex - Volume 2 - Pharmaceutical legislation on notice to applicants and regulatory guidelines for medicinal products for human use. for Type IA/IB variation notifications, summary of product characteristics (SmPC), package information Volume 2C - Regulatory Guidelines. - Guidance Guideline on Summary of Product Characteristics - SmPC EudraLex - Volume 6 Notice to Applicants and. Regulatory Guideline on preparation of Summary of Product Characteristics SPC - Pharmaceuticals for. EudraLex - Volume 6 - Notice to applicants and regulatory guidelines for for Type IA/IB variation notifications, summary of product characteristics (SPC), Guideline on summary of product characteristics · EudraLex - Volume 2 - Pharmaceutical Legislation Notice to applicants and regulatory guidelines medicinal This page lists the reference documents and guidelines on the quality of product information for to be used in the summary of product characteristics (PDF/328.62 KB) . Office for Official Publications of the European Communities · EudraLex.