References
- Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004.
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- Draft reflection paper on the use of methyl- and propylparaben as excipients in human medicinal products for oral use (EMA/CHMP/SWP/272921/2012).
- Draft Guideline on the use of phthalates as excipients in human medicinal products (EMA/CHMP/SWP/362974/2012).
- Concept paper on the need for revision of the guideline on excipients in the label and package leaflet of medicinal products for human use (CPMP/463/00) (EMA/CHMP/SWP/888239/2011).
- Guideline on pharmaceutical development of medicines for paediatric use (EMA/CHMP/QWP/805880/2012 Rev. 2).