Under the new rules – which were adopted by the Commission last week – certain drugs and biologics must feature an inverted black triangle symbol on their information leaflets by the end of the year if they are deemed to need additional safety monitoring by the EMA's Pharmacovigilance Risk Assessment Committee (PRACS).
In addition, unapproved medicines currently under review will need to carry the mark by September 1 if they are granted marketing approval by that date.
Plans for the labelling scheme attracted industry comment when announced last year with various groups indicating that adding the symbol to leaflets was a complex logistical challenge that would take at least six months, and maybe as long as nine months, to implement.
The EC told in-Pharmatechnologist.com that: “When setting the timelines, the Commission took the comments into account, which we received from stakeholders during the public consultation. In fact, the Commission Regulation contains an adapted mechanism to avoid any disruptions in the supply chain.
The Commission explained that while drugmakers have nine-months to adapt currently marketed products “in individual cases this nine months deadline may prove difficult to comply with, the Regulation allows to agree with the competent authorities exceptionally on longer deadlines.
It also said that to avoid potential shortages existing inventory does not have to be modified adding that: “Overall, the mechanism is intended to balance public health interest in a quick uptake of the additional monitoring concept with the operational and practical needs of pharmaceutical companies.”
This contention was bourne out by comments from the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The industry group told in-Pharmatechnologist.com the published Regulation acknowledged the challenges of applying such changes "by providing a certain level of flexibility to introduce revised packaging into the marketplace in order to minimize any risks of shortages.”
“EFPIA welcomes the ability given to companies to maintain products already on the market, without the black symbol, so that existing stocks in the supply chain can be used until exhausted.”