Mon-24-03-2014, 15:34 PM
Just had an email from GSK the makers of Polytar as follows: It may be of interest
Quote:
As you may know, we have experienced a succession of complex manufacturing and regulatory challenges with Polytar Liquid and Polytar Plus. As a result, the earliest we now expect the return of Polytar Liquid and Polytar Plus is 2016. Unfortunately, we cannot give you a date for resupply for Polytar Emollient at this time. More information will be provided as soon as we can, but we would like to reassure you that we are committed to resupplying these products wherever feasible, and we have a dedicated team managing this as a priority.
We had hoped to bring back Polytar products more quickly and we are very sorry for this delay.
We would like to explain why this is a time-consuming process. Since we last updated you on the Polytar range we have identified the need for additional, essential manufacturing and licensing updates which are required before we can make these products again.
First of all, to improve product quality and ensure regulatory compliance, Polytar Liquid and Polytar Plus are being reformulated. As part of the process, we need to ensure new ingredient specifications meet robust European regulatory requirements and GSK quality standards. This can take some time, and is similar to the exhaustive quality and review process required for the development of new medicines.
In addition, the former supplier of several active ingredients for Polytar has stopped making them, so we have to find a new supplier. Due to the unique complexity and composition of the natural ingredients used to make Polytar, when we find a new supplier, we will need to work closely with them to ensure they have the right technology and we will need to validate their production processes, exactly as we do our own. New equipment will also need to be installed in a dedicated facility, before we can begin commercial manufacturing again.
Finally, to meet current European regulatory, quality and stability requirements, we also need to source new bottles and cartons for Polytar. This requires dedicated equipment as well, which will need to be thoroughly tested at the GSK site where the bottles and cartons are filled.
Once again we can only apologise that bringing back the Polytar range is taking longer than we had hoped it would. In the meantime we are asking consumers to speak with their GP or pharmacist for advice on alternative treatment options.