--- title: How to fill in the details for SmPC type IA variation description: Instructions for submitting Type IA SmPC updates on Publisher, including how to enter regulatory approval information, select the correct dates, and manage SmPC updates following an MHRA rejection. --- [Skip to content](https://support.datapharm.com/knowledge/smpc-type-1a-variation#main-content) English Show submenu for translations ![6789782.fs1.hubspotusercontent-na1.nethubfs6789782Product logosDatapharm\_RGB\_Logo1 (3)-4](https://support.datapharm.com/hs-fs/hubfs/social-suggested-images/6789782.fs1.hubspotusercontent-na1.nethubfs6789782Product%20logosDatapharm_RGB_Logo1%20(3)-4.png?width=500&height=115&name=6789782.fs1.hubspotusercontent-na1.nethubfs6789782Product%20logosDatapharm_RGB_Logo1%20(3)-4.png) - [Datapharm homepage](https://www.datapharm.com/) Open main navigation Close main navigation - [Datapharm homepage](https://www.datapharm.com/) - English Show submenu for translations - www.datapharm.com www.datapharm.com Welcome to the emc academy - There are no suggestions because the search field is empty. 1. [emc Academy](https://support.datapharm.com/knowledge?hsLang=en) 2. [emc publisher](https://support.datapharm.com/knowledge/emc-publisher?hsLang=en) 3. [Uploading Documents & Content](https://support.datapharm.com/knowledge/emc-publisher?hsLang=en#uploading-documents-content) # How to fill in the details for SmPC type IA variation Type IA and IAIN changes can be uploaded once implemented, without an MHRA acceptance letter, as the MHRA does not issue an approval for these variations. When submitting an update to a SmPC on publisher for a type IA and IAIN variation complete the regulatory approval section shown below. Guidance on each field follows the image: ![](https://support.datapharm.com/hs-fs/hubfs/undefined-Oct-22-2026-08-14-30-4893-AM.png?width=670&height=272&name=undefined-Oct-22-2026-08-14-30-4893-AM.png) 1. **Confirmation checkbox:** tick the box confirming the SmPC has been approved by the MHRA, or is a minor variation (Type IA or IAIN). 2. **MHRA Approval date:** Enter the date from section 10 of the SmPC. As there is no MHRA approval notification for a Type IA change, it should match the implementation date, which is the date your company internally approved the revised SmPC, as per QRD annotated template version 10.4, Annex 1 SUMMARY OF PRODUCT CHARACTERISTICS, **section 10 of the SmPC**: - *For type IA variations affecting the product information, the date of revision of the text should be the date of implementation of the change by the MAH.* 3. **Date of first authorisation/renewal (section 9) or SmPC date of revision (section 10)**: enter whichever of these is more recent. Please make sure the date you enter matches the date printed in the SmPC.   **What if the MHRA rejects a Type IA change?** If a change is rejected, it can no longer be implemented, so the SmPC on emc should no longer show that change. 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