Veterinary Medicines Directorate
Woodham Lane, New Haw
Addlestone, Surrey
KT15 3LS
United Kingdom
Tel: +44 (0)1932 336911
Fax: +44 (0)1932 336618
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APPLICATION FOR RENEWAL OF A MARKETING AUTHORISATION FOR A
NATIONALLY AUTHORISED PRODUCT
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 in Veterinary Medicines Guidance
Note (VMGN) No. 2 entitled ‘Marketing Authorisations for Veterinary Medicines Products’.
SECTION 1 – ADMINISTRATIVE DETAILS
1.
Product Name:
2.
Vm No:
3.
Name and Address of 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: Natalie Shilling
VMD/L4/Authorisations/042/C - #629375 – Issued 14/05/2014
SECTION 2 – AUTHORISATION DATES
7.
Please state the date the authorisation was first approved / issued:
8.
Please state the date the authorisation is due for renewal:
SECTION 3 – ADDITIONAL INFORMATION
9.
Applicants should confirm below that they have read and complied with the
requirements set out in Annex 1. If not, applicants should provide justification for
any missing data or non-compliance as without this the application will not be
validated.
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: Natalie Shilling
VMD/L4/Authorisations/042/C - #629375 – Issued 14/05/2014
ANNEX 1
Before completing the renewal application form please check your Marketing
Authorisation documents to ensure that the VMD has been informed of all changes in
particulars relating to this product.
Please send one copy of your renewal application form and the following information
to the VMD at least six month prior to the date of renewal.
Administrative requirements

An application form

Summary of Product Characteristics (SPC); this must be submitted electronically
and in Word format. Failure to do so will result in your application being deferred
at validation.

Colour mock-ups of the current labels and package leaflet (if applicable); these
must be submitted electronically. Failure to do so will result in your application
being deferred at validation.

Any data that has been requested as a previous condition should be provided at
the time of renewal and should be presented in the standard ‘Notice to Applicants’
format together with a covering document detailing clearly the previous
application(s) and Marketing Authorisation(s).

Any other data that is necessary to bring the Marketing Authorisation in line with
Directive 2001/82/EC as amended.

Details of all variations applied for in the last five years including:
 The date of application.
 The nature of the application.
 The date of approval or refusal.

Confirmation that no other applications are currently underway on this product:
Changes to a marketing authorisation cannot be made during the renewal
process; in order to ensure an MA is as up-to-date as possible; any changes to
the MA must be made by way of a variation(s), which must be submitted and
approved prior to the submission of the renewal application. Therefore, it is the
applicant’s responsibility to ensure that this is done in time for the renewal to be
submitted and approved before the MA ceases to be valid.
If any changes are identified during the renewal procedure, the renewal may be
granted subject to a condition(s), i.e. the applicant may be asked to submit a
variation following the conclusion of the renewal procedure in order to change the
Author: Natalie Shilling
VMD/L4/Authorisations/042/C - #629375 – Issued 14/05/2014
MA accordingly, which may be charged for and processed as per normal
procedures.
Please note that a renewal application will not be accepted while the MA is
subject to on-going variation procedures (including Type IA procedures), and
variation applications will not be accepted while the MA is subject to a current
renewal procedure.
Pharmacovigilance requirements

A Periodic Safety Update Report. For further information about what is required,
please see Section 6 of Part I of Volume 9b or contact Reena Agrawal on 01932
338430, or via email at: r.agrawal@vmd.defra.gsi.gov.uk . Reena works in the
Pharmacovigilance team at the VMD.
Expert Statements
Because the basis of the renewal is a re-evaluation of the benefit-risk balance of the
product, the marketing authorisation holder should also submit an expert statement
discussing the benefits and risks afforded by the product in the context of the
experience gained since authorisation, including risks to human beings.
The expert statement should address quality, safety and efficacy issues and conclude
with a benefit-risk statement. The expert statement should also be signed and
accompanied by a CV of the expert.
Quality requirements

Quality Expert Statement:
There is no updating of Part II quality data at renewal. The marketing
authorisation holder has an obligation to keep this updated on an on-going basis
throughout the life of the product using the variation procedure.
The quality expert statement should include a declaration of compliance with
Article 27(1) of Directive 2001/82/EC which obliges marketing authorisation
holders to “... take account of technical and scientific progress and introduce any
changes...” The statement should confirm that all changes relating to the quality of
the product have been made following applications for variations and that the
product conforms to current Ph. Eur. monographs and CVMP quality guidelines.
The statement should also include the currently authorised specifications for the
active substance and the finished product as well as the qualitative and
quantitative composition in terms of the active substance(s) and the excipient(s).
The statement should also confirm that the marketing authorisation holder will
continue to monitor the stability of the product in accordance with agreed stability
protocols and will inform competent authorities should a problem arise together
with a recommended course of action.

A list of all sites to be retained:
 Manufacturing sources of the active substance(s) including any reference to
the Drug Master File/certificate of suitability, where appropriate.
 Manufacturers of the dosage form.
Author: Natalie Shilling
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 Assemblers of the dosage form.
 Authorised manufacturer(s) (or importer) responsible for batch release in the
EEA
 Site(s) in EEA or in countries where an MRA or other Community
arrangements apply, where batch control/testing takes place
 Importers of the final dosage form from outside the EU (if applicable).

A statement, or when available, a certificate of GMP compliance, not more than
three years old, for the manufacturer(s) of the medicinal product listed in the
application issued by an EEA competent authority or MRA partner authority.

For manufacturing sites of the medicinal product not located in the EEA or in the
territory of an MRA partner, a list of the most recent GMP inspections carried out
by other authorities indicating the date, inspection team and outcome.
In accordance with Article 50(f) of Directive 2001/82/EC manufacturing authorisation
holders are required to use as starting materials only active substances which have
been manufactured in accordance with the detailed guidelines on good
manufacturing practice for starting materials as adopted by the Community. The
following declarations are required:

A declaration by the Qualified Person (QP) of each of the manufacturing
authorisation holders listed in the application form where the active substance is
used as a starting material.

Where different, a declaration by the Qualified Person (QP) of the manufacturing
authorisation holder(s) listed in the application as responsible for batch release.
These declarations should state that all the active substance manufacturer(s)
referred to in the application form operate in compliance with the detailed
guidelines on good manufacturing practice for starting materials.

From January 2002, the VICH Topic GL18 – Impurities: Residual Solvents, came
into effect for existing Veterinary Medicinal Products. This is in accordance with
the timetable laid out in EMEA/CVMP/423/01 – Note for Guidance – Application of
the VICH Guideline on Residual Solvents to Veterinary Medicinal Products
containing Existing Active Substances. Hence, a declaration should be provided
regarding the residual solvents used in the manufacture of all of the ingredients of
the final product, or in the manufacture of the final product itself. A table should
be provided listing each of the ingredients, the solvents likely to be present and a
statement on whether option one or option two of the VICH guideline has been
utilised to demonstrate compliance. An assurance that compliance with the
Guideline will be maintained throughout the life of the product should also be
given. Depending on the solvents present and their levels, variation applications
may be required. In the first instance, data on residual solvents should be
provided as part of the company’s response to this letter. Once the data have
been assessed, the company will be advised what further applications, if any,
should be submitted.

A declaration of the current TSE status with updated EDQM certificates of
suitability, if appropriate (compliance with the actual version of the TSE guideline).
See http://www.vmd.gov.uk/General/AppsPage/format.pdf
andhttp://www.vmd.gov.uk/General/AppsPage/notes.pdf
Author: Natalie Shilling
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Expert Statement Regarding Safety and Efficacy

The clinical experience gained with the product in animals and the current
benefit-risk of the product on the basis of the PSUR and clinical data compiled
should be discussed, making reference to any relevant new information in the
public domain (e.g. literature references, clinical trials and clinical experience,
new treatments available), which may change the conclusion of the risk-benefit
evaluation made at the time of the original authorisation or last renewal. A clear
statement by the clinical expert is required that the product can be safely
renewed at the end of a 5-year period for an unlimited period, or any action
recommended or initiated should be specified and justified. The intention is that
the clinical expert takes responsibility for the continued availability of the product
on the market. The expert should ensure that the benefit-risk evaluation has been
adequately updated, taking account of all new relevant information, either by
endorsement of the statement within the PSUR or by appropriate
supplementation within the expert statement. Confirmation that the product
remains efficacious should be provided (e.g. no reports of lack of efficacy).
The expert should confirm that the Competent Authorities have been kept
informed of any additional data (e.g. results from clinical studies) important for the
assessment of the benefit-risk ratio of the product concerned.

Furthermore the human safety of the product should be discussed, and a
discussion of user and consumer safety included, which reviews the any
relevant information that has come to light in the reporting period e.g.
appropriate and sufficient warnings on the product literature in relation to any
human SARs; the current withdrawal period(s) and any relevant information
from residues surveillance that indicates the withdrawal periods may not be
sufficient, etc.

In order for the benefit-risk balance to be re-evaluated, the expert should also
address the risks of any undesirable effects on the environment. A separate
environmental risk assessment (ERA) is not required as part of the renewal
documentation. Specific information on environmental risk and an ERA may
be requested if:

A potential risk to the environment is identified on basis of existing information
and/or

Data have become available indicating a potential problem arising from the
presence in the environment of an active substance related to the use of a
veterinary medicinal product and in relation to the inherent ecotoxicity of the
active substance and/or its metabolite(s).
MARKETING AUTHORISATIONS FOR PARALLEL IMPORTS (MAPIs)
The requirements listed under Quality, Expert Statement Regarding Safety and
Efficacy and Environmental Safety are not applicable to renewal applications for
MAPIs; however, the following quality information should be provided:

A list of all sites to be retained:
Site of relabelling
Author: Natalie Shilling
VMD/L4/Authorisations/042/C - #629375 – Issued 14/05/2014
Applicant’s UK Wholesale Dealer’s site
Author: Natalie Shilling
VMD/L4/Authorisations/042/C - #629375 – Issued 14/05/2014