PAGB will provide a written submission to the MHRA by September 30th, 2017 regarding paraffin-containing products and will work with the MHRA, fire brigades, and other stakeholders to ensure clear and consistent communication about the risks. (AI summary)
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3. By providing Information and evidence t0 the reguiator, the Meaicines ana Healthcare products Regulatory Agency (MHRA) wiil adaress these points in turn: 1, Accurate and meaningful warning statement PAGB and its member companies recognise that clear information needs to be made available to warn of the risk of increased flammability of clothing and bedding which has been in contact with paraffin-containing emollients In addition to ensuring warning statements are included on the packaging of all appropriate products, it is imperative that these warnings are consistent as well as clear and meaningful to members of the public who will read them PAGB has been working with its member companies to develop wording which we will submit for user-testing to ensure its clarity_ User-testing is a vital part of this process: It is important that users are involved in the drafting of any waming statements, such that we can be confident they will be clearly understood when placed on packaging Following the results of user-testing, PAGB will work with MHRA to ensure there is consistency in implementation of a standard warning for packaging and patient information leaflets_ PAGB requested a meeting with MHRA to discuss this process in May 2017, we have been given the opportunity to make a written submission to the agency, which we will do by 30th September 2017 and we hope to have the opportunity to meet with MHRA officials thereafter.
2. Communicate the potential risk effectively The Coroner's report of Mrs Taylor's accidental death highlights that repeated advice of the fire hazards from healthcare professionals and family members was ignored It is therefore important that; in addition to the inclusion of an appropriately worded warning on packaging and on patient information leaflets, the risk is adequately communicated to healthcare professionals, care workers and other professional groups_ PAGB will continue to work collaboratively with MHRA, Fire Brigades and other stakeholders to ensure there is clear and consistent communication, and those health and care professionals have appropriate information on how to minimise and manage the risk with their patients.
3. Provide information and evidence to MHRA PAGB member companies have already submitted data on adverse events associated with paraffin-containing products to the MHRA review; which is currently underway: PAGB has been advised that following this MHRA review, expert advice will be sought from the Commission on Human Medicines (CHM), the timescale for this is autumn 2017 _ As mentioned previously, PAGB will be providing a written submission to the CHM (via MHRA) by 30 September 2017 and we hope to have the opportunity to meet with MHRA officials after that date_ To conclude, would like to reassure you that together with our member companies, we are taking this issue seriously and working hard to ensure we take all the appropriate actions we can as an industry to prevent future incidents from occurring_ key
Please do not hesitate to contact me if you have any further questions or require any additional information _