1. The purpose of this concept paper was to seek the input of stakeholders into the project on the review and consolidation of medicines legislation. The last 40 years has seen a growing number of amendments or expansions of the legislation which governs medicines for human use in the UK. Given the changes that have taken place over the years there is a strong case for reviewing and consolidating current legislation.
2. The document identifies a number of areas where possible reforms can be made. We welcomed views from stakeholders on the areas that are outlined, and other areas which you feel warrant attention.
3. The vast number of amendments and expansions of medicines legislation over the last 40 years has resulted in a very complex and fragmented set of legal provisions. The MHRA has recently commenced a project with one of the goals being to seek opportunities to make improvements and to simplify provisions where possible.
4. With input from stakeholders over the next 2 to 3 years we intend to develop a medicines legislative framework which is comprehensive, comprehensible and fit for current purpose. At the same time, where possible, we hope to reduce legislative burdens without compromising on the protection provided by legislation.
5. The main focus of this review will be on national legislation. European Union legislation is included in the scope of the project, in terms of rationalising the form of the legislation, but we will not be able to make any substantive changes, other than where it contains national discretions.
How to respond
6. This document was circulated to a number of stakeholders including professional bodies, trade associations and industry. The list of stakeholders is available to download below – replies were welcome from all interested parties.
7. The MHRA will consider your responses in determining those areas of medicines legislation which may require consideration and to help finalise the list of topics for priority consideration. Following this period of informal consultation and determination of priority issues, we will embark on a number of formal, specific consultations on Agency proposals for change.
The outcome of this consultation is available below as a download document.