EMA additional New active substances Health professionals and Drugs appear on New products will initially Yes. ‘additional monitoring scheme (mandatory)* consumers encouraged to monitoring’ list included for 5 years. Initial Article 23 of report all suspected period of inclusion for [Will be introduced All biological medicinal Symbol () will appear in the Regulation (EC) adverse reactions to these other products decided on in September 2013 products (mandatory) Summary of Product No 726/2004 sets products. a case-by-case basis. as a result of the Characteristics and Package out requirement Products with marketing 2010 EU Regulatory agencies are Leaflets (equivalents of PI and Time on list depends on for EMA and authorisation granted pharmacovigilance advised to review the CMI), followed by a statement need for increasing Member States to subject to particular legislation.] statistical outputs from explaining that the medicine is awareness about safe and set up, maintain conditions (optional).† EudraVigilance (the under additional monitoring, effective use of product and make public a central database for and encouraging health and additional information list of medicines After marketing adverse reaction reports professionals and consumers to evaluate of the product, subject to authorisation, if sponsor to medicines licensed in to report adverse reactions. knowledge of the safety ‘additional required to undertake a the European Union) every profile, etc. monitoring’. post-authorisation safety or 2 weeks for drugs on list. efficacy study or to put in place a risk management system (optional). * in Australia as chemical entities’ for safe and effective use, measures for ensuring safe use to be included in risk management system, post-authorisation safety †conditions ‘new study, post-authorisation efficacy study, compliance with reporting of suspected adverse drug reactions stricter than in the Regulations, conditional approval, marketing authorisation under exceptional circumstances, existence of an adequate pharmacovigilance system.
EMA additional monitoring scheme [Will be introduced in September 2013 as a result of the 2010 EU pharmacovigilance legislation.] New active substances (mandatory)* All biological medicinal products (mandatory) Products with marketing authorisation granted subject to particular conditions (optional).† After marketing authorisation, if sponsor required to undertake a post-authorisation safety or efficacy study or to put in place a risk management system (optional). Health professionals and consumers encouraged to report all suspected adverse reactions to these products. Regulatory agencies are advised to review the statistical outputs from EudraVigilance (the central database for adverse reaction reports to medicines licensed in the European Union) every 2 weeks for drugs on list. Drugs appear on ‘additional monitoring’ list Symbol () will appear in the Summary of Product Characteristics and Package Leaflets (equivalents of PI and CMI), followed by a statement explaining that the medicine is under additional monitoring, and encouraging health professionals and consumers to report adverse reactions. New products will initially included for 5 years. Initial period of inclusion for other products decided on a case-by-case basis. Time on list depends on need for increasing awareness about safe and effective use of product and additional information to evaluate of the product, knowledge of the safety profile, etc. Yes. Article 23 of Regulation (EC) No 726/2004 sets out requirement for EMA and Member States to set up, maintain and make public a list of medicines subject to ‘additional monitoring’. * in Australia as ‘new chemical entities’ †conditions for safe and effective use, measures for ensuring safe use to be included in risk management system, post-authorisation safety study, post-authorisation efficacy study, compliance with reporting of suspected adverse drug reactions stricter than in the Regulations, conditional approval, marketing authorisation under exceptional circumstances, existence of an adequate pharmacovigilance system.