Article 23(5) of EC Regulation number 726/2004 states that drugs deemed to require additional monitoring – generally those for which safety risks only become apparent when they are on the market – should be labelled with the phrase ‘This medicinal product is subject to additional monitoring.'
This new warning text - which is one of a number of pharmacovigilance measures set out in the regulation - will be preceded by a ‘black symbol’ to further identify drugs that need extra vigilance.
In a concept paper issued earlier this week the Commission called for industry feedback on how long manufacturers will need to adapt and print new product information leaflets for such drugs, asking specifically how many ‘weeks’ such work would take.
The EC also wants to know what impact the new labelling requirements will have on drugs packaged before the new rules come into effect.
It also asked manufacturers how long stocks of packaged medicinal products that include the patient information leaflet are held before being released for sale and supply.
Industry feedback is requested by January 10 next year.
EFPIA response
The European Federation of Pharmaceutical Industries and Associations (EFPIA) told in-Pharmatechnologist.com the complex nature of the European drug market means that implementing such changes is going to take some time.
"At this time the European market is divided into different national markets with different requirements on languages and sometimes also regarding the content of summary of product characteristics and package information leaflets.
"It will therefore take time to introduce new requirements such as the black symbol, this especially on the package information leaflet, as it is part of the physical package."
'Black symbol'
The precise design of the ‘black symbol’ has not yet been chosen, however the Commission reiterated that all pharmaceuticals selected for additional post-market surveillance will need to be labelled from July 2013.
Given this requirement a design decision sooner rather than later would be welcomed by the drug industry.
Additionally, national regulatory agencies like the UK's Medicines and Healthcare products Regulatory Agency (MHRA), which has already committed to replacing its own 'black triangle' labelling system with the commission's design, will also welcome a EC decision.