Module 12 2019

EMA Gateway

• Gateway or WebClient • Since 1 March 2014, the use of the Gateway is mandatory for the CP. After this date, EMA should not accept any CD/DVD • For PSUSA (Single Assessment of PSUR), the Gateway/WebClient was already mandatory. • Since 1 April 2014, EMA extended the use of the Gateway to: referral procedures, veterinary medicines submissions and pediatric submissions. • Only one account/password per company

The Organisation for Professionals in Regulatory Affairs