Draft guidance for comment on the UK's arrangements under the hospital exemption scheme for advanced therapy medicinal products. Deadline for comments is Friday 18 September

This draft guidance has been developed on the proposed UK exemption scheme for advanced therapy medicinal products (ATMPs) under Article 28 (2) of Regulation EC No 1394/2007 (104Kb) ('the ATMP Regulation').

The question and answer document does not replace the existing material that is published on the website about the Regulation but aims to clarify the specific areas where we can provide advice. In addition, we have developed a draft advice form which will replace existing arrangements for companies who wish to seek advice on the regulatory classification of a product. This form should only be used where advice is sought on product classification.

We would welcome comments on the draft advice form. An impact assessment is also attached. An impact assessment formed part of the formal consultation package on the proposed implementation arrangements for the Regulation which was issued in July 2008. We would welcome comments on the possible impact of the new arrangements.

We expect the new hospital exemption scheme arrangements to apply from around the autumn. We would welcome comments on the documents by 18 September 2009. Information about the launch of the exemption scheme arrangements will be posted on the website in due course.

Comments should be sent to caroline.brennan@mhra.gsi.gov.uk