Environmental Risk Assessment (ERA) – revised guideline to assess risk of human medicines for the environment…….

An Environmental risk assessment (ERA) of medicines ensures that the potential effects of pharmaceuticals on the environment are studied and that adequate precautions are taken in case specific risks are identified. The EMA has published a revision of its guideline on the environmental risk assessment (ERA) of human medicines for a six-month public consultation. Stakeholders […]

Excipient guideline update

The updated Annex to “Excipients in the labelling and package leaflet of medicinal products for human use” guideline was published on the 09/10/2017. This updated Annex in all EU languages can be found here: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_001646.jsp In addition, Notice to Applicants Volume 2C has been updated in March 2018 to reflect this updated annex. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-2/c/guidelines_excipients_march2018_en.pdf What […]