Editorial Changes

Editorial Changes

So, you have noticed an error in your SPC, but the error is historical, typographical, or editorial. The primary factor with editorial changes is that they do not require an in-depth assessment, and should therefore, be acceptable as type IB changes, or on some occasions type IA. Published guidance to review in relation to editorial changes: Question 3.16 Under which classification category can editorial changes be submitted?

Answer: Editorial changes in the SmPC (and corresponding PIL/labelling), updates in line with the QRD template, adaptation to excipient guidelines, etc. without any impact on the content of the dossier, can be included within the scope of another planned type IB or type II variation under chapter C that affects the SmPC. No separate variation submission is necessary. The mention of chapter C in the above refers to chapter C, of the variations guidelines, i.e. Safety, Efficacy, Pharmacovigilance Changes.

The Article 5 recommendations :

Include situations which are not covered by the variations guideline, if you can locate your change in this document and the classification assigned is a type IA, then you are unlikely to suffer from a refused variation. Essentially all type IAs must be assigned a change code, Z (unforeseen) type IA/typeIAIN codes are not permitted, unless stated in the below spreadsheet. Tip scroll down to row 58 for some commonly occurring examples e.g. Adverse Drug Reaction wording.

The best way to ensure a swift grant of these changes which may impact the quality of the product, is to submit as a stand-alone type IB variation. Type IB variations have a 14 day validation period and a 30 day assessment period, the fee is £308 for a variation applied to a single product licence. The review time for a type IA is 30 days from receipt of submission, therefore, if the IA is refused, it is going to be a longer wait to see the change corrected, but there is no fee for type IA /type IA/ type IA grouped submissions.

Can the MHRA not fix the error on my behalf?

The Agency does have a team dedicated to correcting errors; however, this team only exists to correct errors which have occurred in-house. If the SPC, or dossier documents submitted were incorrect then, it is the responsibility of the MA holder to rectify them. If you believe the error occurred during case processing by the Agency, then e-mail datareviewteam@mhra.gsi.gov.uk, in order for a swift resolution of your case, please ensure the following are included in the e-mail:
• Applicable PL numbers are listed in the subject line.
• Documents which support the basis by which the error occurred are attached.
• A clear a concise explanation for the error is included in the message body.
• Tracked SPC / Documents are included indicating the proposed update.
• Updated clean SPC / Dossier documents are provided and clearly labelled.