Determination of marketing authorisation (MA) applications made under the Decentralised and Mutual Recognition Procedures - update

Following the notification in Medicines Regulatory News dated 13 March 2008 of our intention to approve marketing authorisation applications (MAA) submitted via mutual recognition and decentralised procedures within 30 days of finalisation of procedures, the following supplement is provided in order to facilitate timely grant of National licences.

Applicants will be requested to provide an amended marketing authorisation (MA) application form (including consolidation of agreed changes during the procedure) by the date of closure of the procedure. This ensures that the MHRA database maintains an accurate record of accepted changes at the time of approval of the marketing authorisation. Portal-user companies are requested to submit the revised MHRA MAA form (including consolidated changes agreed during the procedure) on a single occasion by the final day of the procedure. Companies that do not use the MHRA portal should submit an MS Word ‘track changes’ updated MAA form (reflecting agreed changes) via the MHRA MR-DC Unit  by the final day of the procedure.

The final Summary of Product Characteristics (SmPC), patient information leaflet (PIL), agreed label text and product specifications will continue to be circulated by the Reference Member State (RMS) as part of the official closure of the procedure. This part of the process is unchanged. The final SmPC should also be submitted in MHRA required format along with the national leaflet/label mock-ups within five days of close of procedure.

› Licence application forms
› Special Mail 5: Guidelines on submission of applications to the MHRA

In order to expedite approval of licences, any UK-specific product name issues will be raised with applicants in parallel with the European phase of the procedure. This will enable product name issues to be resolved by close of procedures and the timely submission of National mock up documentation and MHRA format SmPC within five days of close of procedure.

In the event that any submitted label or leaflet mock-up documents do not comply with MHRA requirements and where the applicant is unable to provide compliant documents on MHRA request, the application will be determined based on the harmonised label and/or leaflet text agreed during the procedure. In these circumstances the product may not be placed on the market until the label and/or leaflet mock-ups have been submitted and approved, as previously advised.

› Labels, patient information leaflets and packaging of medicines: Legislation and guidelines

For products for which the marketing authorisation has been determined based only on text, the mock-ups of PIL and labels may be submitted for review under Article 61(3) of the Directive.