European drugmakers are seeking between six months and a year to prepare and print updated product information, including the black symbol for drugs that require additional monitoring as part of their approval.
Under new EU pharmacovigilance requirements enacted last July, manufacturers must include a black symbol on the packages and leaflets of drugs that require additional monitoring. Beginning July 2013, all pharmaceuticals selected for additional surveillance will need to be marked with the symbol.
Last Novermber the Commission asked manufacturers how long it would take to make the changes and - by the time the consultation process closed on January 10 - had recieved responses from 14 firms. On average respondents said it would take between six and nine months, though the overall times varied between two weeks and two years.
In its comments on the consultation, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said the amount of time needed could vary depending on the volume of leaflets, the capacity of the printed packaging development department and other products that could have specific timing considerations, such as seasonal products like flu vaccines.
The EFPIA said “up to 52 weeks after approval of the updated product information could be needed for introduction of the revised product packaging into the supply chain to the warehouse in some cases.”
Similarly, the European Generics Association (EGA) said that in order to “avoid the destruction of any existing material and the ensuing financial implications, 12 months should be considered.”
But the EGA expressed its discontents over black symbol requirements for biosimilars authorized after Jan. 1, 2011, but not for their reference products authorized before the same date. The group noted that such requirements “will put an undue and unfair burden on the biosimilar products which is not based on science because biosimilar products are explicitly approved as equally safe and effective as their reference products.”
The commission also sought information on how long stocks of medicinal products packaged with the product information are held by the marketing authorisation holder or manufacturer before they are released for sale and supply. Industry estimated between four weeks and 12 months, though that could extend to between 18 months and two years depending on whether the turnover of the product is high or low.
EuropaBio, which represents the EU biotech industry, stressed that the timing will depend on the specific list of products that will come under additional monitoring. Both EuropaBio and the EGA said that companies should be able to sell out their existing stocks to reduce write-off costs before the requirements come into effect.
In addition to the black symbol, all products shall contain in the summary of product characteristics and the package leaflet the statement, “This medicinal product is subject to additional monitoring.”
The adoption of the decision selecting the black symbol is scheduled to come this year. The commission will make its decision after consulting with the Pharmacovigilance Risk Assessment Committee.