Veterinary Medicines Directorate
Scope
These variation procedures apply to MAs authorised in Great Britain (GB).
They also apply to MAs that have been authorised in Northern Ireland (NI):
- via a national procedure, that is, not subject of an EU procedure such as the Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) or Centralised Application Procedure (CAP)
- via an EU procedure where the variation is dealt with on a national basis, such as change of legal entity of MA holder.
Further guidance about variation procedures for MAs authorised in NI via an EU centralised procedure can be found on the European Medicines Agency (EMA) website.
Marketing Authorisation Holders
All products included in a variation application must belong to the same marketing authorisation holder (MAH).
In GB and NI, an MAH is identifiable by their unique company number, which forms the first part of a products Vm number, which appears on its labels, for example, 12345/4010.
Product ranges
An MA includes all products that are part of a so-called product range and includes all strengths and pharmaceutical forms of that product.
An example of a product range is as follows:
- Product Name 10 mg tablet for cats and small dogs
- Product Name 20 mg tablet for medium size dogs
- Product Name 30 mg tablets for large dogs
One change to one MA (one product or one product range) is considered a single variation.
Types of variation
There are two types of variation:
- Variations NOT requiring assessment (VNRAs)
- Variations requiring assessment (VRAs)
Variations not requiring assessment
VNRAs have little or no impact on the safety, quality or efficacy of a product. These changes are listed in the guidance.
Variation requiring assessment
Any change that is not listed as a variation not requiring assessment will be considered a variation requiring assessment.
VRAs are listed in the guidance
Not all possible variations are included in the lists of VNRAs and VRAs. If you wish to apply for a variation that is not listed, please contact the VMD prior to submission. Email s.response@vmd.gov.uk and include variation classification request in the subject line.
If you wish to apply for a change that isnt listed to an NI MA, please follow the procedure on the EMA website.
Some unlisted variations that have already been classified by the VMD as unforeseen variations, and are dealt with on a national basis regardless of the scope of the MA, have been given a national U classification category. See Unforeseen Variations section below.
Variations not requiring assessment
A VNRA application may only include one change to one MA (a single variation).
However, to reduce administrative burden on you, we will accept the following VNRA change combinations in a single national application form:
- One VNRA change to multiple products (maximum of 10 products)
- Multiple VNRA changes to one product (maximum of 10 changes)
Multiple VNRA changes to multiple products is NOT permitted.
Combined application forms will be progressed as individual applications and may not all be approved at the same time.
VNRA cannot be grouped with VRA applications but can run concurrently. If the VNRA is dependent on the outcome of a concurrent VRA assessment, the application will be placed on hold pending the VRA approval.
VNRA must be notified to the VMD within 12 months of implementation of that variation.
These notifications are checked to ensure that:
- the correct variation type and category has been selected
- no other changes have been made that havent been applied for
- all conditions have been fulfilled
- all relevant documentation has been provided and is accurate
MA holders will be informed as to whether the variation is approved or rejected within 30 days of receipt. The fee applies regardless of the outcome.
Where at least one of the requirements cannot be fulfilled, the VNRA will be rejected, and you will still be charged. You will need to reapply using the correct VRA category.
For Northern Ireland MA authorised via a European procedure, most VNRA should be submitted via the Union Product Database. Changes to the name, address or contact details of the Marketing Authorisation Holder (A.1.a), or Changes to the labelling or the package leaflet which are not connected to the SPC administrative information concerning the holders representative (C.10.a) or inclusion of traceability stickers in or on the product carton (C.10.c) should be submitted via national applications, as described above.
Further guidance is available from the EMA on Centralised NI MA submissions.
Variations requiring assessment
A VRA is known as one of the following depending on the specified timeframe for that change.
- VRA standard / extended
- VRA reduced
See Timetables for national applications for further information. The shortened timetable will be used for VRA reduced and the standard timetable will be used for VRA standard / extended.
Extensions
Formerly known as extensions there are some variations that fundamentally alter the terms of an MA to either create a new stand-alone MA (new-extension) or change an existing MA (variation-extension).
These former extension changes werent included in the old classification guideline, however they are now included in the list of VRAs with all the other changes requiring assessment.
If you are applying for a former extension that amends an existing MA (variation-extension), this will be dealt with as a VRA standard / extended.
If you are applying for a former extension that results in a new stand-alone MA, it will be dealt with in accordance with new MA procedures and timeframes.
Parallel submissions are not possible for applications that result in a new stand-alone MA due to the different timescales and procedures used on a national basis and in the EU.
Consequential changes to product literature
If a variation results in consequential changes to the Summary of Product Characteristics, labelling or package leaflet, these will be considered as part of the same variation application.
Single variation
An application including one change to one MA (one product or one product range).
Grouped variations
An application including either:
- several VRA changes to one MA (one product or one product range)
- one VRA change to several different MAs (several different products or different product ranges)
- several VRA changes to several MAs (several different products or different product ranges)
A grouped variation will be handled using the longest timeframe associated with any change included in the application.
All changes included in a grouped application must apply to all products.
You cant include a VNRA in a grouped variation.
You cant include a former extension that results in a new stand-alone MA in a grouped variation. However, you can include former extensions that amend an existing MA (variation-extension) in a grouped variation; this application will still be known as an extension-led grouped variation for fee purposes.
It is recommended that you avoid groupings that are entirely unrelated for example, grouping of unrelated quality and safety / efficacy variations. If you do the VMD may decide to run the application on a longer timeframe and additional costs may be incurred.
Workshare variations
EU workshare procedures can be applied to MAs in NI issued following an EU procedure (DCP/MRP/EUCE) only.
It is recommended not to include MAs aligned between GB and NI as this may result in de-alignment. Contact VMD for further guidance should you need to submit an EU workshare involving aligned MAs.