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. 

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

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