On the 7th March 2013 the EU Commission adopted an Implementation Regulation introducing a Black Symbol to identify medicinal products that are subject to additional monitoring.
It has been confirmed that the symbol will be an inverted equilateral black triangle.
- April 2013 – The PRAC will distribute a list of EU approved products which will be subject to intensive surveillance. At the same time they will confirm the intensive monitoring wording to be included in SmPCs and PILs of these products.
- In the UK, the MHRA will write to all existing Black Triangle product holders and there will be a transition period to allow for variations to include the Black Triangle and wording on SmPCs and PILs. The transition period in the UK will end in January 2014.
- July 2013 – all products licensed after this date will be included in the scheme. The Black Triangle will remain on products for approximately 5 years.
The transition period is intended to prevent the need for repackaging to include an updated PIL.
Existing products which have a Black Triangle in the UK will still need a variation to add the EU intensive monitoring wording and Black Triangle to the SmPC and PIL.