2022-03-29 9:31:28
The Human Medicines (Amendments Relating to the Early Access to Medicines Scheme) Regulations 2022 will come into force on 15 April 2022.
The Regulations amend the Human Medicines Regulations 2012 by making provision for the establishment and operation of the statutory version of the Early Access to Medicine Scheme (EAMS) – there has previously been a non-statutory version of the Scheme. The EAMS has the purpose of giving patients with life threatening or seriously debilitating conditions access to medicinal products that are either not authorised or not authorised for that use. The Human Medicines Regulations will have a further exception to the need for certain products to have a marketing authorisation if the licensing authority is satisfied that certain conditions are met regarding ordering, manufacture and distribution. There are also pharmacovigilance requirements and a prohibition on advertising EAMS products.