--- title: When Do We Need to Make a Submission and What Type? description: "  Use emc med data dm+d to make submissions for medicinal products that are: Please Note 📝 Submissions should only be for marketed packs and not all the packs that you are licensed to manufacture. Th" --- [Skip to content](https://support.datapharm.com/knowledge/when-do-we-need-to-make-a-submission-and-what-type#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 med data (dm+d)](https://support.datapharm.com/knowledge/emc-med-data-dmd?hsLang=en) 3. [How to Use emc med data (dm+d)](https://support.datapharm.com/knowledge/emc-med-data-dmd?hsLang=en#how-to-use-emc-med-data-dmd) # When Do We Need to Make a Submission and What Type?   Use emc med data dm+d to make submissions for medicinal products that are: - For primary or secondary care, - Currently licensed, - Available now or within 3 months in the UK. ![](https://support.datapharm.com/hubfs/Knowledge%20Base%20Import/datapharm.freshdesk.comsupportsolutionsarticles7000047762-when-do-we-need-to-make-a-submission-and-what-type-hit.gif) **Please Note** 📝 Submissions should only be for marketed packs and not all the packs that you are licensed to manufacture. The NHS BSA requires an approved SmPC for the majority of submissions.   **You should update emc med data dm+d every time a product changes.** For example, if your product licence/SmPC, packaging, or price changes or if you launch / discontinue a product.     ### You should make a submission/update if there are changes to the following SmPC sections:   #### **Section 1. Name of medicinal product** - If you change your product name, create a product update - For a brand new product, create a new product submission   #### **Section 2. Qualitative and quantitative composition** - If you change your active ingredient name, create a new product submission - For a brand new product, create a new product submission   #### **Section 3. Pharmaceutical form** - If your licensed routes of administration change, create a product update - For a new formulation, create a new product submission   #### **Section 6.1. List of Excipients** - If your excipients change (excipients, flavours, gluten free, sugar free, CFC free, or preservative free status), create a product update   #### **Section 6.5 Nature and contents of container** - If you launch a new pack for an existing product presentation, create a new pack - If you discontinue a pack, create a discontinue pack submission - If you change the packaging of the product e.g. repackage the medicine into a different number of sub packs (strips), introduce or remove a calendar or hospital pack, create a pack update submission.   #### **Section 6.6 Special precautions for disposal and other handling** - For an existing product pack, if you change the limited stability status (if the product has to be made up with a diluent/vehicle), create an update pack submission #### **Section 7. Marketing Authorisation holder** - If your marketing authorisation holder changes (e.g. you divest or acquire products or you merge) please contact the NHS Business Services Authority (NHSBSA) directly. **A submission cannot be made via in-demand.**   #### **Section 8. Marketing Authorisation number(s)** - If your marketing authorisation number changes e.g. you divest or acquire products or you merge, please contact the NHS Business Services Authority (NHSBSA) directly. **A submission cannot be made via in-demand.** - If the body who has approved your product changes, create a pack update submission     ### Other changes may also include:   #### **Change of legal category** - If the legal category changes for a pack, create a pack update submission   #### **Change in controlled drug status** - If the controlled drug status changes for a product, create a product update submission   #### **New product launch** - If you launch a new product, create a new product submission   #### **Product discontinuations** - If you discontinue a product presentation and all its packs, create a discontinued product submission   #### **Change to the price** - If the price for a specific pack changes create a price change submission - If the prices for many packs change at the same time create a mass price update submission   #### **A pack or product is re-instated back to the market** - 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