Guidance

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 one or more member states (MS) and imported into another MS for distribution.

An authorisation (MAPI) granted by the VMD is needed to parallel import products into the UK.

The product to be imported must be authorised in the UK (known as the parent product) and in the MS from which it is to be imported from.

Both should be authorised in accordance with Directive 2001/82/EC, as amended, and meet the criteria below:

  • For biological products; the product to be imported should be identical to the UK authorised product
  • For pharmaceutical products; the product to be imported should be identical to (for food-producing species), or therapeutically the same (for non-food producing species) to the UK authorised product.

Types of MAPIs

National

The parent product is nationally authorised.

Mutual recognition

The parent product is mutually recognised.

MAPI Holders

The holder of a MAPI must:

  • be established within the EU, i.e. have their registered office, central administration, or principle place of business within the UK
  • 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).

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, e.g. 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.defra.gsi.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

Parallel import (MAPI) application form (MS Word Document, 56.4KB)

Guidance for the covering letter

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. If the application is incomplete, it is likely to fail validation.

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

Parent product is mutually recognised:

Validation Validated within 10 days of receipt.
Initial Assessment Approved, refused, or questions asked within 75 days of validation passed
Company Response If questions asked, you should provide a full company response within the deadline set
Sign-off Approved or refused by 130days from receipt. The timescales may be suspended during this time if further information is required from you
Mock-ups Mock-ups approved within 20 days from receipt of correct versions
Issue Following approval, authorisation documentation will be issued within 10 days

Parent product is nationally authorised:

Validation Validated within 10 days of receipt.
Initial Assessment Approved, refused, or questions asked within 90 days of validation passed
Company Response If questions asked, you should provide a full company response within the deadline set
Sign-off Approved or refused by 180days from receipt. The timescales may be suspended during this time if further information is required from you
Mock-ups Mock-ups approved within 20 days from receipt of correct versions
Issue Following approval, authorisation documentation will be issued within 10 days

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 parent product.

If changes are made to the SPC or product literature of the parent 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.

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.

Expiry of a MAPI

To expire a MAPI, you will need to send an email to: s.response@vmd.defra.gsi.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.

Contact us

Email: postmaster@vmd.defra.gsi.gov.uk

Published 30 November 2018