Legal Alert Pharmaceuticals law: New black symbol for medicinal products


Legal Alert Pharmaceuticals law
Legal Alert Pharmaceuticals law


On 7th of March 2013 the European Commission adopted an Implementing Regulation (EU) No 198/2013 on the selection of a symbol for the purpose of identifying medicinal products for human use that are subject to additional monitoring. The Implementing Regulation introduces a new symbol - inverted equilateral black triangle (▼) to identify medicines undergoing additional monitoring. The symbol that will appear on the inside leaflet of certain medicinal products will allow patients and health care professionals to easily identify medicinal products that are undergoing additional monitoring, and its accompanying text will encourage them to report unexpected adverse reactions through national reporting systems.

From September 2013, the symbol will be used to identify the following categories of medicinal products:

• All products with a new active substance authorised after 1 January 2011;
• Biological medicinal products, such as vaccines or plasma derived products authorised after 1 January 2011; and
• Products for which certain additional information is required post-authorisation, or for which authorisation is subject to conditions or restrictions regarding their safe and effective use.

Holders of marketing authorisations granted before 1 September 2013 which concern medicinal products for human use that are subject to additional monitoring shall include the black symbol in the summary of product characteristics and the package leaflet relating to these medicinal products by 31 December 2013.

Stocks of human medicinal products produced, packaged and labelled before 1 January 2014, which do not include the black symbol in the package leaflet may continue to be placed on the market, distributed, dispensed, sold and used until stocks are exhausted.

Legal Alert Pharmaceuticals law