The marketing authorisation holder shall ensure that the product information is kept up to date with the current scientific knowledge, including the conclusions of the assessment and recommendations made public by means of the European medicines web-portal established in accordance with Article 26 of Regulation (EC) No 726/2004.   

The MAH is responsible for regularly monitoring relevant sources of new information and recommendations.  

 For pharmacovigilance referrals according to articles 31 and 107i of Directive 2002/83/EC and for PSUSA procedures (according to article 107e of Directive 2001/83/EC), the PRAC recommendation will be adopted by CHMP or CMDh. 

In case of variation, suspension or revocation, the PRAC recommendation is forwarded to:  

• The CHMP, when at least one centrally authorized product is involved. The CHMP will then adopt an opinion which will be sent to theEuropean Commission for a decision