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A GUIDELINE ON. SUMMARY OF PRODUCT CHARACTERISTICS. (SmPC) accordance with Directive 2001/83/EC, when the marketing authorisation is Training presentations; Scientific guidelines with SmPC recommendations Group, outlines the principles in the European Commission's guideline on SmPC. Article 21 of Directive 2001/83/EC, when the marketing authorisation is issued, the When a guideline exists for the SPC of a specific therapeutic area (e.g. 11 Apr 2017 The European Medicines Agency has released a detailed list of all relevant guidelines with SmPC (Summary of Product Characteristics) 10 Oct 2018 The EU guideline on the Readability of the Labelling and Package Leaflet must be listed as an integrated unit in section 1 of the SmPC, on all 1 Jun 2010 Dir 2001/83/EC. Article 11. Future Regulation on advanced therapy medicinal products. Paediatric Regulation. 1901/2006. SmPC Guideline p.ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol2_en.htm. This guidance should also be read in conjunction with other relevant guidelines that can 25 Jan 2017 Send a question via our website www.ema.europa.eu/contact CHMP guideline on clinical evaluation of new vaccines. annex: SPC. 27 Mar 2017 summary of product characteristics (SmPC) to safe use of drugs in the EU. EMA currently has several guidelines to assist sponsors with Annex: Summary of the scope of the 2009 update of the SmPC guideline the website of the European Medicines Agency (EMEA) www.ema.europa.eu”)