No hiding for black triangle drugs as EMA prepares public list
This article was originally published in SRA
A list of all EU drugs needing a black inverted triangle on their package leaflets and summary of product characteristics (SmPCs) will soon be published by the European Medicines Agency1. The triangle is mandated by the EU pharmacovigilance legislation and is needed on drugs subjected to additional monitoring2.
To ensure there is compliance with this requirement, the EMA says it will publish a list of all medicines that will need to carry this symbol within the next few months. The EMA has also updated its product information template to clarify that standardized text will be needed:
- to accompany the black symbol saying " this medicinal product is subject to additional monitoring ";
- in the SmPC expressly asking healthcare professionals to report any suspected adverse reaction in accordance with the national spontaneous reporting systems; and
- in package leaflets expressly asking patients to communicate any suspected adverse reaction to his/her doctor, pharmacist, healthcare professional or directly to the national spontaneous reporting system.
The EMA is hoping that the updates to the template will help ensure compliance with the black symbol requirement as this template is used by companies to create product information for medicines marketed in the EU.
The revised template also includes additional guidance on how to complete section 10 of the SmPC, further information on the presentation of multipack pack-sizes and some clarifications on the presentation of side effects on the package leaflet. The updated template is available in all official EU languages, as well as in Icelandic, Norwegian and Croatian.
The agency also clarifies the implementation timeline for the black symbol requirement. For medicines subjected to additional monitoring, it will be needed on:
- new marketing authorization applications with an opinion from the EMA’s evaluation committee, the CHMP, in April and May (ie products on which the European Commission's decision is expected before 1 September);
- new marketing authorizations applications with a CHMP opinion as of June (ie products on which the commissions' decision is expected on or after 1 September); and
- existing marketing authorizations granted via the centralized procedure before the publication of the revised product information template (companies are encouraged to use the first upcoming regulatory procedure affecting product information to make the necessary changes).
For all other drugs not subjected to additional monitoring, the EMA is advising companies to use the first upcoming regulatory procedure affecting product information to comply with the revised template.
References
1. EMA press release, 15 March 2013, www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2013/03/news_detail_001740.jsp&mid=WC0b01ac058004d5c1
2. Black triangle for monitored EU drugs to kick in on 1 September, Scrip Regulatory Affairs, 8 March 2013