EMA: New form for submitting post-authorization data concerning medicinal products

The European Medicines Agency (EMA) published a statement on implementation of a new submission form for post-authorization data concerning centrally authorized medicinal products. 

The new form refers to information on safety, efficacy and quality of medicines. Submitting such information may result from various legal bases. The new form was implemented to simplify submission of information by marketing authorization holders. 

According to the EMA’s statement, using the form is mandatory from 1 September 2017. 

The full text of the statement is available under the following link: 
http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2017/08/news_detail_002805.jsp&mid=WC0b01ac058004d5c1