Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Implementation of the new medicines legislation on 30 October 2005 will affect the requirements for the submission of renewal applications. A further renewal under the new legislation will be required for products authorised through the mutual recognition and centralised procedures. The UK will not be requesting submission of further renewal applications for nationally authorised products which have been renewed at least once before 30 October 2005. This will apply to marketing authorisations (MAs) which are due to expire on 30 January 2006 onwards (i.e. those for which renewal applications are not required under the current legislation).
The Periodic Safety Update Report (PSUR) data should still be submitted. We will give more information on the transition of the five to three-year PSUR cycle once we have a final European position as it is our intention to be consistent with this advice. However, as an interim measure the next five-year PSUR data should be submitted when due. The data should be submitted within 60 days of the data-lock point which should be set so that submission is at least three months prior to the date when the MA would have expired.
The PSUR data together with any PSURs previously submitted should cover the period since the last renewal. Where the period is covered by two or more reports a Summary Bridging Report covering all the PSURs (even those already submitted) should be submitted. Previously submitted PSURs need not be re-submitted provided that a listing of the original submission dates is appended to the Summary Bridging Report but these reports should be available on request.
When submitting PSURs that are not accompanying a renewal application, please state clearly in the covering letter that it is for a national MA which has already been renewed (state date of MA renewal) together with confirmation that the data covers the period since the last renewal.
Renewal applications received up until 30 October 2005 will be processed in accordance with current procedures.
For further information, please see our main section of the renewal of licences:
Medicines and Healthcare products Regulatory Agency
October 2005
