Veterinary Medicines Directorate
Woodham Lane, New Haw
Addlestone, Surrey
KT15 3LS
United Kingdom
Tel: +44 (0)1932 336911
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APPLICATION TO VARY AN ANIMAL TEST CERTIFCATE
An incomplete application form may delay the application process.
Further guidance about this application type is available on GOV.UK
SECTION 1 – ADMINISTRATIVE DETAILS
1.1
Product Name:
1.2
ATC Number:
1.2
Name and Address of ATC Holder:
Company Name:
Address:
Email Address:
Telephone No:
1.3
Name and Address of Sponsor1 (if different to 1.2 above):
Company Name:
Address:
Email Address:
Telephone No:
1.4
Contact Details for this Application:
Name:
1
The Sponsor is the individual, company or organisation who takes responsibility for the initiation,
management and, usually, the financing of the clinical trial.
VMD/L4/Authorisations/038/C - #713642 – Issued
Email Address:
Telephone No:
1.5
Invoice Details: Email address of where the invoice should be sent to.
Email Address:
1.6
e-Issuing Details: Email address of where the authorisation documentation
should be sent to (if different from 1.4 above).
Email Address:
SECTION 2 – PRODUCT DETAILS
2.1
Active substance(s) quantitative:
2.2
Pharmaceutical Form:
SECTION 3 - APPLICATION DETAILS
Tick the appropriate box
Variation
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
Name or designation of the product
Name and address of the ATC holder
Name and address of the manufacturer and/or assembler
Justified increase in the number of animals to be treated with the test product
Criteria for inclusion of animals in the trial
Criteria for exclusion of animals from the trial
Criteria for withdrawal of animals from the trial
Safety monitoring
Safety warnings
Disposal warnings
Name of the overall trial monitor
Qualifications of the overall trial monitor
Trial site
Site investigator
Product shelf-life
Product labelling
Note: All other categories of change to the ATC require the submission of a new ATC
application. If the product formula, species and purpose of the trial remain the same, a
Type A procedure and fee will apply to the new application.
VMD/L4/Authorisations/038/C - #713642 – Issued
RELATED APPLICATION(S) (Please specify)
BACKGROUND (Please give full details and background for the application)
PRESENT
PROPOSED
Section 6 – 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
Name in
Job
Title
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.
VMD/L4/Authorisations/038/C - #713642 – Issued