1. Commission Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use (2003). Off J L159:46–94
2. Regulation (EC) No 1394/2007 of the European Parliament and of the Council on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (2007). Off J L324:121–137
3. Commission Directive 2009/120/EC of amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products (2009). Off J L243:3–12
4. EMA/CAT/CPWP Guideline on the risk-based approach according to annex I, part IV of Directive 2001/83/EC applied to advanced therapy medicinal products (EMA/CAT/CPWP/686637/2011).
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139748.pdf
5. CHMP Guideline on safety and efficacy follow-up—risk management of advanced therapy medicinal products (EMEA/149995/2008).
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500006326.pdf