For each active ingredient, complete the fields and then click 'Save Ingredient'. The ingredient(s) will then be displayed in its own box
Ingredients can be removed using the 'X' button in the top right of the ingredient box.
If you add an ingredient and make a mistake, Delete the ingredient from the list and then re-enter the correct ingredient details.
Ingredient Name
Ingredient means the active ingredients in a product as listed on the SmPC. The ingredient should use the INN (International Non-proprietary Name) where possible.
To find an active ingredient, click the drop down menu. Enter all or part of the active ingredient name into the search box and a list of ingredients will appear below the search box.
If you are launching a product with a brand new active ingredient or formulation, please start a New Product submission. When choosing the ingredient, you can then request that a new ingredient be added by clicking the link in the med data (dm+d) submission system.
You need to save your submission as a draft at that stage, wait for the NHSBSA to confirm the addition of the ingredient to their database (this may take a few days) and then continue with your submission.
Basis of Pharmaceutical Strength (BOPS)
The dm+d database requires you to state which part of the active ingredient the strength is based on. The strength can be:
- based on ingredient substance - the strength is based on the complete ingredient
- based on base substance - the strength is based just on the base of the active ingredient
For example:
Amitriptyline 10mg tablets contain amitriptyline hydrochloride – the strength of 10mg refers to amitriptyline hydrochloride. The Basis of Pharmaceutical strength = ingredient substance = amitriptyline hydrochloride.
Acebutolol 100mg capsules contain acebutolol hydrochloride – the strength of 100mg refers just to acebutolol. The Basis of Pharmaceutical strength = base substance = acebutolol.
Select the appropriate choice from the drop down list.
Basis of Substance Strength (BOSS)
Click the Lookup button. Enter all or part of the BOSS name into the search box and click on the exact BOSS match for your product.
If the BOPS is based on the ingredient substance, leave this field blank.
If the BOPS is based on the base substance, search and add the name of the base substance.
Numerator Strength
The numerator strength is made up of 2 parts.
In the first box, type the strength of the product as a numerical value.
In the second box, click on the units of strength from the drop down list e.g mg, ml etc.
For example paracetamol 500mg tablets would be entered as 500 and mg.
Denominator Strength
Some products will have a denominator strength e.g. solutions, suspensions, creams or patches. These products can be expressed as 'per strength' products e.g. paracetamol 250mg per 5ml.
If your product is expressed as "per strength", please complete this section.
For the dm+d database, "per strengths" are usually entered as per ‘unit of measure’ (i.e. per 1 gram or per 1ml). For example, paracetamol 250mg/5ml oral suspension should be entered as 50mg/ml. Paracetamol 250mg/5ml would have a numerator strength of 50 and mg and a denominator strength of 1 and ml.
