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EC consults on launch timing for new pharmacovigilance symbol

Wants to know how introduction of 'black symbol' will affect pharma

MHRA black triangle symbolEuropean regulators have begun consulting on plans to bring in new labelling requirements for medicines that require additional monitoring.

The product information for such medicines, including their packaging leaflet and summary of product characteristics (SPC), will be identified with a 'black symbol' and the European Commission (EC) is considering whether the arrangements need a phasing-in period.

The EC needs to select a black symbol by July 2013, when it will replace national measures – such as the black triangle used by the MHRA in the UK (pictured above).

But it recognises pharma “may need a certain amount of time in order to comply with the new requirement”.

This is particularly true for companies whose products come under the new additional monitoring rules but that have already been authorised – meaning their existing packaging will need to be changed and reprinted.

Consequently the EC's consultation document notes the need to “balance the public health interest with the practical and operational limitations of pharmaceutical companies”. 

The labelling requirements, which were contained in this summer's European pharmacovigilance changes, also mandated a Europe-wide list of products that are subject to additional monitoring. This will include biosimilars and biologics. However, it is not yet clear when this list of products will be drawn up or come into effect.

The Commission's public consultation on the new symbol is open to the public and private organisations and will run until January 10, 2013.

It will cover two topics designed to help the Commission assess the potential impact of the change on medicine stocks.

• How much time a marketing authorisation holder needs to adapt and print the updated product information 

• How long are stocks of medicinal products packaged with the product information held by the marketing authorisation holder (or the responsible manufacturer) before being released for sale and supply.

Read the phasing-in requirements consultation in full

26th November 2012

From: Regulatory



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