The MHRA wrote to companies in 2014 asking for products to put forward for the White List which would be exempt from the FMD changes. As we were not aware of the letter at the time we did not submit any products. Can products still be added to the White List?
Yes. Article 46 Delegated Regulation deals with notifications to the commission of additional medicinal products that are at risk or not at risk of falsification. Annex III and IV Delegated Regulation provide forms for submission of these. All submissions must be made by the MHRA. Please contact MHRA at : FMD.firstname.lastname@example.org