You should use emc in-demand to make submissions for medicinal products that are for primary or secondary care, that are currently licensed and either available now or within 3 months in the UK. 


Submissions should only be for marketed packs and not all the packs that you are licensed to manufacture. The NHSBSA requires an approved SmPC for the majority of submissions. 


You should certainly consider using emc in-demand every time a product changes, for example if your product licence/SmPC, packaging or price changes or if you launch or discontinue a product.


More specifically you should make a submission 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 discontinue 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

  • If a pack or product was removed from the market and is then re-instated, create a reinstate pack submission