Veterinary Medicines Directorate
Woodham Lane, New Haw
Addlestone, Surrey
KT15 3LS
United Kingdom
Tel: +44 (0)1932 336911
Fax: +44 (0)1932 336618
Search for VMD on GOV.UK
APPLICATION FOR A MARKETING AUTHORISATION FOR A PARALLEL IMPORT
(MAPI)
An incomplete application form may delay the application process.
If submitting in hard-copy, please use block capitals.
Further guidance about this application type is available on GOV.UK.
Delete as appropriate:
This is an application to import a product Nationally Authorised or Mutually
Recognised in another Member State
SECTION 1 – ADMINISTRATIVE DETAILS
1.
Proposed product name in the UK:
2.
Registered Company Number:
3.
Name and Address of Proposed Marketing Authorisation Holder:
Company Name:
Address:
4.
Contact Details for this Application:
Name:
Email Address:
5.
Invoice Details: Email address of where the invoice should be sent to.
Email Address:
6.
e-Issuing Details: Email address of where the authorisation documentation
should be sent to (if different from 4 above).
Email Address:
Author: HStenson
VMD/L4/Authorisations/029/C - #630675 – Revised May 2015
7.
Site of Operations:
8.
Name and qualifications of the person responsible for supervising the operations:
9.
Particulars of the Manufacturer’s Authorisation for proposed site of labelling/ relabelling:
10.
Particulars of the applicant’s UK Wholesale Dealer’s Authorisations:
11.
Name of the Qualified Person in the EU / EEA responsable for
Pharmacovigilance:
SECTION 2 – PRODUCT DETAILS
12.
13.
Please provide the following information about the product to be imported; if
multiple numbers of member states are to be quoted for mutually recognised
products you will need to complete this section for each one.
i.
EU / EEA Member State from which the product is to be imported from:
ii.
Name of the product in that member state:
iii.
Target Species:
iv.
Reference number of the marketing authorisation granted for the product
in the above member state:
v.
Name and address of the holder of the above marketing authorisation:
vi.
Pack Details:
Size Container Closures Dosing Device -
Please provide details of the existing UK marketing authorisation which the
applicant believes to be identical to, or not therapeutically different from, that to
be imported.
i.
Name of product:
ii.
Marketing Authorisation (Vm) No.
iii.
Name and address of the authorisation holder
Author: HStenson
VMD/L4/Authorisations/029/C - #630675 – Revised May 2015
14.
15.
Has evidence been provided in the application package to show the following:
i.
For biological products, the product is identical for food-producing & nonfood producing species:
ii.
For pharmaceutical products, the product is identical for food-producing
species:
iii.
For pharmaceutical products, the product is therapeutically the same for
non-food producing species:
Does the product to be imported differ in any way from the product covered by
the UK marketing authorisation?
Delete as applicable:
YES
NO
If yes, please specify what the differences are. Please note, for biological
products, in particular vaccines, unless you can prove the product to be imported
is identical to the UK authorised product, the application will be refused.
16.
Please confirm if the following have been provided (state Yes or No)
i.
A copy of the label and package leaflet from the member state with an
English translation:
ii.
A copy of the Summary of Product Characteristics (SPC) for the originator
product in the UK together with the label and package leaflet:
iii.
An SPC, package leaflet and label (colour mock-up) to be used for
marketing the product in the UK:
iv.
In instances where it is not practical to obtain a copy of the labelling, i.e. a
cylindrical container, a photograph of the label:
v.
Copies of the current Wholesale Dealer’s Authorisations and
Manufacturer’s Authorisation for the proposed labelling site (if proposed
site is not in the UK, a English translation will be required):
vi.
A detailed description of the arrangements to be adopted for re-labelling
the imported product:
Author: HStenson
VMD/L4/Authorisations/029/C - #630675 – Revised May 2015
vii.
A detailed description of the pharmacovigilance system and, where
appropriate, the risk management system that the applicant will put in
place:
viii.
Sample(s) of the proposed packaging as intended for marketing in the UK:
ix.
The applicant should confirm (in writing) that there has been an agreement
from the specified OMCL regulatory authority/ies to share the release
certificate for the release of the relevant vaccine batch/s with the VMD.
17.
Please confirm the name and address of the proposed distributor of the product;
if not the proposed authorisation holder, please provide a copy of the UK
Wholesale Dealer’s Authorisation (WDA) or Manufacturing Authorisation for the
distributor.
18.
Please confirm that you have read, understood and complied with the
requirements set out in Chapter 4 of VMGN No. 2.
Delete as applicable:
YES
NO
If no, the application form will not be accepted.
SECTION 4 – DECLARATION
I apply for the application as described above. I confirm that the information given in support of this
application is correct at the time of submission.
Signature
Job Title
Name in
Date
BLOCK LETTERS
If any information provided in this application is later found to be false or incorrect, the
Secretary of State may suspend or revoke the authorisation.
Author: HStenson
VMD/L4/Authorisations/029/C - #630675 – Revised May 2015
ANNEX 1
The data requirements for a MAPI are listed below.
For MAPIs based on a nationally authorised parent product; separate applications must be
submitted for each MS that the MAPI product is to be imported from.
For MAPIs based on a mutually recognised parent product; the name of each MS from
which the MAPI product is to be imported should be included on the same application form.
If granted, the import of the MAPI product from each MS will be covered by the
authorisation.
The VMD will liaise with the MS from which the product is being imported to obtain
information to help the authorisation process. The timescales for assessing the application
will be suspended pending receipt of the information requested. WARNING: Experience
shows that it can take a long time to obtain the information from other MSs; therefore, we
strongly advise you to contact the MS to encourage them to respond to queries as quickly
as possible.
You should provide the information requested in the application form as follows:

Detailed Description of the Pharmacovigilance System (DDPS)
You should provide a detailed description of the pharmacovigilance system (DDPS), and
where appropriate, the risk management system that will be put in place by the MAH. The
MAPI holder must fully comply with the requirements set out in VMGN 11 Pharmacovigilance Guidance on Adverse Events.
In particular, a MAPI holder must:
•
Establish systems specific to each product to ensure that any batch recalls
or safety issues in the country of export are identified and reported to the
VMD.
•
Notify the VMD immediately of any events or developments in the country or
countries from which the product is imported which may affect the safety,
quality or efficacy of the product, or the terms of the MA, including:
■
■
■
■
any variations to the authorisation in that country
any recalls of batches
any revocation or suspension of the authorisation
any information available to the importer concerning
adverse events (AEs) or other factors which could affect
safety in use.
If there is an impact on a MAPI from an adverse event (AE) involving a similar product, the
VMD will inform the MAPI holder of any risk to human or animal health or the environment
which has come to their attention. Likewise, the VMD may inform other MAHs of any risk to
human or animal health or the environment which has been identified through an AE
involving a MAPI product. The VMD may notify the parent company of an AE involving a
MAPI product.

Re-labelling
Author: HStenson
VMD/L4/Authorisations/029/C - #630675 – Revised May 2015
You must provide a detailed description of the arrangements to be used for re-labelling the
MAPI product. This information should include:
•
•
•
•

the site of operations
the name and qualifications of the person responsible for supervising the
operations
if re-labelling in the UK, particulars of the ManA
if re-labelling outside the UK, a copy of the ManA for each site concerned
Manufacture
For pharmaceutical products, it is not necessary for the parent and MAPI product to be
manufactured by the same company, although the products should be therapeutically the
same, unless justification can be provided to explain any possible differences.
To ensure that the withdrawal period is appropriate, it is necessary to establish the identical
nature of the formulation for pharmaceutical products authorised for food-producing
species. In some cases the VMD may have to rely on information from other MSs to verify
the identical nature or therapeutic equivalence of the products.
For biological products, it is necessary for the parent and MAPI product to be manufactured
by the same company, because the products must be identical.

Batch Release: Biological Products
You must provide confirmation that the competent authority (CA) in the exporting country is
happy to provide batch release certificates to the UK for the parent product, upon request.
Please note – the VMD is content to provide batch release certificates to other MS for
products being exported out of the UK and into another MS, i.e. a MAPI is held in another
MS and the parent product is being exported from the UK. The request must come from the
competent authority in the other MS and not from the MAPI holder. Email:
batchr@vmd.defra.gsi.gov.uk
Author: HStenson
VMD/L4/Authorisations/029/C - #630675 – Revised May 2015