1. Introduction On 22 November 2019, the European Medicines Agency (“EMA”) published an updated Annex to the European Commission’s Guidelines concerning excipients in the labelling and package leaflet of medicinal products for human use. This updated Annex provides a list of the excipients for which specific information should appear in the package leaflet. The list
On 11 April 2016 a draft Guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (“the Draft Guideline”) were published by the European Medicines Agency (“EMA”).