The MHRA has published a concept paper for its proposed review and consolidation of medicines legislation in the UK, a project which it anticipates will last for up to 3 years.

The basis for the review is that, as a result of medicines legislation increasingly being derived from Community law and advances made in medicines themselves, the Medicines Act 1968 has been heavily amended and expanded numerous times, which has resulted in a complex and fragmented body of legislation, which is often difficult to negotiate and apply.

The MHRA therefore considers it appropriate to review this legislation with the aim of simplifying, clarifying and improving it wherever possible, without compromising the safeguards to public health afforded by it. The review will also seek to remove provisions of national legislation that are no longer for purpose or conflict with Community law.

The review will be focused on all national legislation governing medicines for human use (including homeopathic and herbal medicines), and whilst Community legislation is within the scope of the review, substantive changes to it cannot of course be made other than where national discretions are permitted.

The review will have two strands running in parallel:

(i) the consolidation of existing national legislation, to be made by way of a Legislative Reform Order, a legislative measure that can be used to amend primary legislation without the need to place a new Bill in the legislative programme; and

(ii) the simplification of legislation, focusing on national legislation governing, inter alia, the following:

a. clinical trials; authorisations;

c. manufacture and wholesale;

d. labelling and packaging;

e. advertising; and

f. pharmacovigilence.

The concept paper setting out the proposed consolidation and review in more detail is available from the MHRA’s website ( and the MHRA is currently seeking input from all stakeholders, including professional bodies, trade associations and industry. The deadline for submitting comments to the MHRA is 27 March 2009.