Search
Agency pre-authorisation procedural advice for users of the centralised procedure 14 March 2017 EMA/339324/2007 Volume 2B, Module 1 CTD Directive 2001/83/EC as amended Does the same apply to national a [...] ERA is required? Yes, an ERA is not required for natural substances, such as Vitamins Minerals Amino acids Peptides Proteins Carbohydrates Lipids Also exempt are: Vaccines Herbal medicinal products Could [...] environmental-risk assessment of medicinal products for human use 01 June 2006 EMEA/CHMP/SWP/4447/00 Corr 2 Questions and answers on the Guideline on the environmental risk assessment of medicinal products for