From Dr K. H. Jones, MD
SIR,—Your issue (PJ, February 5, p202) contains a brief article reporting that the Medicines Control Agency will no longer reject applications for a parallel import because individual strips are not over-labelled. This requires clarification.
Following advice from the European Commission, in December last year we issued advice to parallel import licence holders about over-labelling of blister strips. We explained that it was no longer a requirement to include the name of the parallel importer on the blister strip, as long as it appeared on the outer packaging and the user package leaflet. We would not, therefore, refuse to grant such a licence to import solely on the basis of a failure to include the parallel importer's name on the blister strip.
Although we will no longer insist on the name being on individual strips, we nevertheless believe that over-labelling in this way is useful, not least because of the potentially significant implications for the importer in the event of a batch recall. If the parallel importer is not identified on the blister pack and the carton and leaflet are not available, all holders of PI licences will have to be contacted and each one asked to recall stocks of the implicated batch. There is, therefore, considerable merit in continuing with current practice.
Keith Jones
Director and Chief Executive, Medicines Control Agency