How to apply for a number of changes to the same marketing authorisation (MA) at the same time in a single application procedure.
A single application can be submitted to the Veterinary Medicines Directorate for all strengths and pharmaceutical forms of one product.
The products must all contain the same active substance and belong to the same company (marketing authorisation holder (MAH)).
Mutually recognised products
Related mutually recognised products all have the same stem number which forms part of the product’s application procedure number. The procedure number stays with a product throughout its life.
The procedure number is set out as follows:
CC is the two-letter code of the Reference Member State, eg UK
D is either V for Veterinary, or H for Human
nnnn is the stem number denoting the product related to an active substance and MAH
sss is the speciality number denoting the strength and/or pharmaceutical form of a product.
- VMD 10 mg tablet for cats and small dogs UK/V/100/001
- VMD 20 mg tablet for medium size dogs UK/V/100/002
- VMD 30 mg tablets for large dogs UK/V/100/003
This example shows that products in the same product range, with the same active substance and belonging to the same MAH, will all have the same stem number, in this case 100.
To group mutually recognised products together in a grouped variation application, all products must have the same stem number.
National products do not have procedure numbers or stem numbers. However, the same principles apply and only those products that form part of a product range and meet the criteria above may be grouped together in a grouped variation application.
If MAHs wish to group together unrelated products they may do so by submitting a workshare variation.
Products authorised under a different legal basis such as informed consent (Copycats) are not considered to be related to the parent product for the purpose of grouped variations. This is also true where there might be multiple informed consent marketing authorisations (MAs) derived from the same parent product, these multiple copycats cannot be grouped.
The same restriction applies to generic products and parallel imports which are all stand-alone MAs in their own right.
Type IA Changes
This advice does not apply to Type IA led grouped variations, which may include products that aren’t related.