HPRA has updated their ‘Guide to Renewal of Marketing Authorisations-Human Medicines’ to Version 7 (AUT-G0025-7).
Acorn Regulatory has summarised the key changes, which are listed below.
This document has been given a significant overhaul, with some sections merged.
Content-wise, it’s really just layout changes, but the main additions are:
– Section 3 now refers to the ‘expanded renewal procedure with full documentation’ section of the CMDh Best Practice guide on processing of renewals in the MRP and DCP. This guidance covers any products authorised nationally or through MR that are exceptions and cannot follow the general 30-day standard renewal procedure timeline. The circumstances under which a product may require the ‘expanded’ process are detailed in the CMDh BPG, this is generally if concerns regarding the benefit/risk balance of the medicinal product have been identified and a 90-day expanded timetable with requirements for submission of documentation listed in Annex 3 of the CMDh BPG is required. HPRA BPG Renewals link
– Section 3.1 now covers updates to all PI (section 3.1 +3.2 from version 6 have been merged)
– Section 3.6 ‘documentation validation checks’ has been included, it contains details in relation to submitting a valid renewal with information previously from Section 2 of Version 6, however, an additional statement has been added: ‘Failure to respond or the submission of an incomplete response will result in the MA being considered withdrawn and the files closed. Any corrections to the product information required after it has been issued must be applied for using the variation procedure’.
– Section 4 ‘Guidance for specific product types’ from version 6 has been removed and is no longer detailed in Version 7.
