Changes to the way mock-ups are dealt with: Guidance for Marketing Authorisation Holders
Effective from 1st April 2016. This applies to Marketing Authorisation and veterinary homeopathic remedy applications.
We are changing the way we deal with mock-ups from 1st April 2016.
This applies to all Marketing Authorisation (MA) and veterinary homeopathic remedy (VHR) applications not dealt with via the centralised application procedure.
The key change is that you will only have to provide revised mock-ups in some cases rather than for all applications that affect them.
When will we want to see revised mock-ups
- For all new MA and VHR applications
- For all variation-extension applications
- For renewal and variation applications where the number and / or type of change being proposed means it would be easier to see revised mock-ups rather than annotating the changes ourselves
- For any application on a product where we do not currently hold electronic versions of the mock-ups
Where mock-ups are not requested, we will annotate the agreed changes onto the latest authorised versions and issue these to you.
All mock-ups will be assessed by the same team during a separate mock-up phase; this will help ensure consistency of approach.
Mock-ups should reflect the agreed Quality Review of Documentation (QRD) and we will be placing more emphasis on the assessment and maintenance of QRD text.
All mutually recognised products have agreed QRD text, but most nationally authorised products do not. To help us get QRD text for all nationally authorised products and to facilitate mock-up procedures for these products, please see Getting QRD text for national products.
Revised guidance can be found on the SPCs and Product Literature page.
National applications that pass validation on / after 1st April 2016 will be subject to the new procedures.
An application that is already in the system and passed/s validation before 1st April will be subject to current mock-up procedures.
EU applications that have already entered the national phase will be subject to current mock-up procedures.
Getting QRD text for national products
You should submit QRD text for review against the latest authorised mock-ups and SPC, using this QRD Text form (MS Word Document, 49.6KB) by 31st July 2017; no fee will apply.
If your product is due for renewal, you can submit QRD text for approval as part of the renewal process instead.
We will check your QRD text and aim to issue the agreed version back to you within 90 days of receipt. Once QRD text has been agreed, please submit a revised version with all future applications that affect it.
If you wish to submit revised QRD text and mock-ups for assessment, ie. to update the QRD using the latest template, please do so under cover of a Type IB variation (C.II.6(b)), which will be dealt with under normal variation procedures.
We will no longer identify non-marketed pack sizes on the memorandum document. When submitting mock-ups for assessment, please use the category C.II.6(b), not C.I.z.
For further information, email firstname.lastname@example.org and put ‘Revised Mock-Up Procedure’ in the subject line.
Published: 24 March 2016