Marketing Authorisations for Parallel Import of veterinary medicines
Guidance for the pharmaceutical industry on applying for a marketing authorisation for parallel import (MAPI).
What is parallel importing
Parallel importing is when a product is bought from wholesalers in a foreign country and imported into the UK for distribution.
An authorisation (MAPI) granted by the VMD is needed to parallel import products into the UK for sale and supply.
The product to be imported must be authorised in the UK and also authorised in the country of export. The product should be authorised in accordance with standards at least equivalent to those in the UK.
For biological products, the product to be imported should be identical to the UK authorised product
Types of MAPIs
Simple
The product to be imported must be identical to the UK product; and both the UK product and imported product must be held by the same MA holder. This would apply in all cases for products indicated for the treatment of food producing species.
The finished product manufacturer may be different as long as the product to be imported remains identical to the UK product.
In exceptional cases, we may consider minor deviations from the UK product if it is considered of benefit and does not impact safety,
Complex
The product to be imported may differ to the UK product, but only in terms of minor differences in formulation that don’t impact the therapeutic effects for example, colour or flavour.
The product to be imported must be held by the same MA holder of the UK product.
A complex MAPI may only be applied for in relation to non-food-producing species.
Horses are considered food-producing regardless of whether or not the product is indicated for food use.
MAPI Holders
The holder of a MAPI must:
- be the holder or have a contract with a holder, of a suitable UK Wholesale Dealers’ Authorisations (WDA); the WDA must be authorised to parallel import veterinary medicinal products
- be the holder or have a contract with a holder, of a suitable Manufacturer’s Authorisation (ManA), authorised to carry out over-labelling operations, that is assembly operations
Distribution categories
An authorised product will have a distribution category which relates to the retail supply of the product, eg. a product classified as Prescription Only Medicine - Veterinarian (POM-V) may only be supplied by a veterinary surgeon or a pharmacist and must be supplied in accordance with a prescription from a veterinary surgeon.
Further information about the distribution categories is in the guidance for retailers.
The distribution category of a MAPI product will be the same as the distribution category of the parent product.
The distribution category can also be referred to as the legal category.
The Vm Symbol
An authorised product, including one subject of a MAPI, will have an authorisation number preceded by the symbol Vm on its product literature, for example the labels; this offers users a clear guarantee that the product has been assessed and approved in accordance with the instructions on the product literature.
How to apply
Prior to submission
You are welcome to meet with VMD assessors to discuss your proposed application. To arrange a meeting, please email: postmaster@vmd.gov.uk and include ‘Request to arrange a company meeting’ in the subject line.
Submission
See Submission of an application for an animal medicine licence for more details.
Application Form
You must apply online through the VMDS
Data Requirements
The data requirements for MAPIs are annexed to the application form.
Validation
All applications are checked (validated) upon receipt.
It is up to you to identify and submit all the necessary information in support of your application, including information to assure the identicality of the respective products. If the application is incomplete, it is likely to fail validation.
Any data that is deemed commercially confidential can be sent directly to the VMD from the regulatory authority of the country of export of the product in question.
The email address for the submission of data is: s.response@vmd.gov.uk.
Assessment
Once the application has passed validation, it will proceed into the assessment phase.
The timescales may be suspended if we need further information from you.
The onus is on you to prove the product to be imported is identical and / or therapeutic equivalent to the UK authorised product; failure to do so will result in the application being refused.
If the outcome is to approve an application, you will be sent authorisation documentation at the end of the application procedure.
Upon approval of a MAPI, the VMD will inform the holder of the UK authorised product that a MAPI has been issued for one of their products.
SPCs and product literature
See SPC and Product Literature guidance for more details.
Timescales
Further information about application timescales can be found on the Timetables for national applications.
Fees
Once an application has passed validation, you will be sent an invoice for the fee
For further information about fees see Application fees for animal medicines.
You can use the fees calculator to help you work out what the fee will be.
The VMD issues all invoices electronically, so please provide a valid email address of where to send the invoice; failure to do so will result in your application being rejected.
Post authorisation steps
Renewals
A MAPI must be renewed five years following initial authorisation.
Details about how to apply for a renewal can be found on Apply to renew a marketing authorisation for a veterinary medicine.
Variations
The SPC and product literature of the MAPI must remain the same as the UK equivalent product.
If changes are made to the SPC or product literature of the UK equivalent product, you must submit a national unforeseen variation to bring the SPC and product literature of the MAPI product back into line with it.
If you wish to make any other changes to your MAPI, you will need to submit a variation application to the VMD.
Details about how to apply for a variation can be found on Apply to change a marketing authorisation for an animal medicine.
The onus is on you to ensure your MAPI is kept up-to-date and in line with the UK equivalent product.
UK Public Assessment Reports (UKPARs)
There will be no public assessment report (PuAR) for MAPI products due to the lack of available data.
The SPC, label text, and a post authorisation assessment (PAA) document will be available on the Product Information Database (PID).
Batch Release of Biological Products
MAPIs for biological products are subject to the same batch release arrangements that apply to all biological products – see batch release.
It is your responsibility to provide evidence that the batch to be released is subject of a valid release certificate issued by the country from which the product it to be imported. Failure to provide evidence that the imported product has been officially released will result in the batch release request being refused
Expiry of a MAPI
To expire a MAPI, you will need to send an email to: s.response@vmd.gov.uk
Expiry of an MAPI means that no more product may be released by the qualified person (QP) on or after the date of expiry. Any product already QP released may still be placed on the market for sale and supply after this date unless the MAPI has been expired due to safety reasons. In this case, this will be noted in the expiry letter sent to you.
Last updated 23 March 2022 + show all updates
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Updated guidance following policy changes introduced post Brexit.
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Amended to refer applications to the VMDS where the application form is online.
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Addition of link to new timetables for national applications page
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First published.