REPUBLIC
OF CYPRUS
ΚΥΠΡΙΑΚΗ
ΔΗΜΟΚΡΑΤΙΑ
DECLARATION OF THE END OF A CLINICAL TRIAL
The Veterinary Medicinal Products (Control of Quality, Registration, Supply, Manufacture, Administration
and Use) Laws Ν. 10(Ι) of 2006 to 2011
ΔΗΛΩΣΗ ΠΕΡΑΤΩΣΗΣ ΚΛΙΝΙΚΗΣ ΔΟΚΙΜΗΣ
Οι περί Κτηνιατρικών Φαρμακευτικών Προϊόντων (Έλεγχος Ποιότητας, Εγγραφή, Κυκλοφορία,
Παρασκευή, Χορήγηση και Χρήση) Νόμοι Ν. 10(Ι) του 2006 έως 2011
Registrar of the Council of Veterinary
Medicinal Products
Veterinary Services
Ministry of Agriculture, Rural Development
& Environment
Lefkosia, 1417
CYPRUS
Tel: +357 22 805122 or 113
Fax: +357 22 805122
For official use:
Date of receipt:
To be filled by the sponsor or his legal representative
Member state in which the declaration is being made:
REPUBLIC OF CYPRUS
(Vet Form 159)
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Trial identification
Full title of the trial:
Sponsor
Legal representative of the sponsor in
the Community
Name:
Name:
Address:
Address:
Tested investigational medicinal product 1
Product name or code:
1
Name of active substance(s):
When more than one IV, please provide a numbered list
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End of trial
Yes
No
Date of the
end of trial
(DD/MM/YY)
- Is it the end of the trial in Cyprus?
--/--/--
- Is it the end of the complete trial in all
Member States concerned by the trial?
--/--/--
Is it a premature ending of the trial?
Is it a temporary halt of the trial?
If yes, complete the following boxes:
What is (are) the reason(s) for the halt or
the premature ending?
- Safety
- Lack of efficacy
- The trial has not commenced
- Other
-
if yes, please specify
Number of animals still receiving treatment at the time of the termination in the MS
concerned by the declaration:
Briefly describe in an annex (free text):
-
the justification for a halt or premature ending of the trial
-
the proposed management of animals receiving treatment at time of the
halt or of study termination
-
the consequences of early termination for the evaluation of the results and
of overall risk benefit assessment of the investigational veterinary product
Signature of the sponsor or his legal representative:
I hereby confirm that the above information is correct. I shall prepare the clinical trial
report and submit a summary to the Council of Veterinary Medicinal Products as
soon as available.
Name:
Date:
Signature:
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