The concept of additional monitoring and the black symbol were introduced
by new EU laws on the safety-monitoring
of medicines, started to come into effect in 2012.
Any new medicine authorized after 1 September 2013 which is subject to
additional monitoring will include the black symbol in the package leaflet and the summary
of product characteristics when it is placed on the EU market.
The legislation affects medicines authorized in the EU after 1 January
2011. Therefore, there will be a transition period for medicines authorized
between January 2011 and August 2013.
For medicines that are already authorized, marketing-authorization holders
are encouraged to use the new template at the next regulatory procedure
affecting the product information. If there are no such procedures, companies
should submit a type-IAIN variation no later than 31 December 2013.
The European Medicines Agency has published a video and a factsheet in all
official European Union (EU) languages today 1 October explaining the meaning
of the black triangle, which is now starting to appear in the product information of certain authorized medicines
in the EU.
All medicines on the EU market are carefully monitored. If a medicine is
labelled with the inverted black triangle, it does not mean that it is unsafe;
the purpose of the symbol is to actively encourage healthcare professionals and
patients to report any suspected adverse reactions observed with the medicine,
either because the medicine is new to the market or because there is a
limitation to the data available on its safety.
This system will help Regulatory authorities to collect information to
monitor real-life experience with medicines. Regulatory authorities look at all
reports of adverse reactions, alongside all the information they already have,
to make sure that the benefits of medicines remain greater than their risks and
to take any necessary action to optimize safe and effective use.
Following criteria applies for additional monitoring status to a medicine:
- it contains a
new active substance authorized in the EU
after 1 January 2011;
- it is a biological medicine, such as a vaccine or a
medicine derived from plasma (blood), authorized in the EU after 1 January
2011
- it has been
given a conditional approval (where the
company that markets the medicine must provide more data about it) or
approved under exceptional circumstances
(where there are specific reasons why the company cannot provide a comprehensive
set of data)
- the company
that markets the medicine is required to carry out additional studies, for
instance, to provide more data on long-term use of the medicine or on a
rare side effect seen during clinical trials.
Other medicines can also be placed under additional monitoring, based on a
decision by the Agency's Pharmacovigilance Risk
Assessment Committee (PRAC).
