REPUBLIC
OF CYPRUS
ΚΥΠΡΙΑΚΗ
ΔΗΜΟΚΡΑΤΙΑ
REQUEST FOR AUTHORIZATION OF A CLINICAL FIELD TRIAL ON A VETERINARY MEDICINAL PRODUCT
The Veterinary Medicinal Products (Control of Quality, Registration, Supply, Manufacture, Administration and
Use) Laws Ν. 10(Ι) of 2006 to 2011
ΑΙΤΗΣΗ ΓΙΑ ΕΚΔΟΣΗ ΑΔΕΙΑΣ ΔΟΚΙΜΩΝ ΚΤΗΝΙΑΤΡΙΚΩΝ ΦΑΡΜΑΚΕΥΤΙΚΩΝ ΠΡΟΪΟΝΤΩΝ
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 805112 or 113
Fax: +357 22 805122
For official use:
Date of receiving the
request:
Date of request for
additional information:
Grounds for non acceptance
Yes
Date of request for
information to make it valid:
Date of valid application:
No
If yes, date:
Date or receipt of additional/
amended information:
Authorization
Yes
No
If yes, date:
File No:
Fee Paid:
F18 No:
(Vet Form 158)
1/12
To be filled in by the applicant:
A.
TRIAL IDENTIFICATION
Member State in which the submission is being made:
REPUBLIC OF CYPRUS
Full title of the trial:
Sponsor’s protocol
code number,
version and date
(please attach):
Sponsor Study
Number:
B.
IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE REQUEST
B 1. SPONSOR
Name of Organization:
Name of the person to contact:
Address:
Telephone number:
Fax number:
e-mail:
Β 2. LEGAL REPRESENTATIVE OF THE SPONSOR IN THE COMMUNITY FOR THE PURPOSE OF THIS TRIAL (IF
DIFFERENT FROM THE SPONSOR)
Name of Organization:
Responsible person to contact:
Address:
Telephone number:
Fax number:
e-mail:
STATUS OF THE SPONSOR:
Commercial 1
Non commercial
1A
commercial sponsor is a person or organization that takes responsibility for a trial which is part of the development program
for a marketing authorization of a medicinal product, including post marketing trials.
2/12
C.
APPLICANT IDENTIFICATION
REQUEST FOR THE COUNCIL OF VETERINARY MEDICINAL PRODUCTS
Sponsor
Legal representative of the sponsor
Person or organization authorized by the
sponsor to make the application. In that
case, complete below:
Organization:
Name of contact person:
Address:
Tel. number:
Fax number:
e-mail:
3/12
D. INFORMATION ON INVESTIGATIONAL VETERINARY MEDICINAL PRODUCT(S) BEING USED IN THE TRIAL:
VETERINARY MEDICINAL PRODUCT BEING TESTED OR USED AS A COMPARATOR
If the trial is performed with several investigational veterinary products (IVP), use extra pages and give each IVP a
sequential number; Information should be given for each product, likewise if the product is a combination
product, information should be given for each active substance.
Indicate which of the following is described below, then repeat as necessary for each of the
numbered IVPs to be used in the trial (assign numbers from 1-n):
This refers to the IVP number:
IVP being tested:
IVP used as a comparator:
D 1. STATUS OF THE INVESTIGATIONAL VETERINARY MEDICINAL PRODUCT TO BE USED IN THE TRIAL
D 1. (a) Has the IVP to be used in the trial a
Marketing Authorization (MA):
If yes, specify for the product to be
used in the trial
YES
NO
Trade
name
Name of the
MA holder
MA
number
 In the Member State concerned by this
submission?
- If yes to this question and if the IVP is not
modified but the trade name and the MA
holder are not fixed in the protocol.
If no to the previous question,
 In another member state from which it is
sourced for this trial?
- If yes, specify,
- in which country?
- the trade name
- the Marketing Authorization Holder
If no to the 2 previous questions,
 In a third country from which it is sourced
for this trial?
- If yes, in which?
4/12
D 2. BIOLOGICAL/ BIOTECHNOLOGICAL INVESTIGATIONAL VETERINARY MEDICINAL PRODUCTS INCLUDING
VACCINES
TYPE OF PRODUCT
YES
NO
Extractive
Recombinant
Vaccine
GMO
Plasma derived products
Others
If others, specify:
D 3. AUTHORIZED SITE RESPONSIBLE IN THE COMMUNITY FOR THE RELEASE OF THE INVESTIGATIONAL
VETERINARY MEDICINAL PRODUCT IN THE COMMUNITY
This section is dedicated to the finished investigational medicinal products i.e. veterinary medicinal products
randomized, packaged, labeled and released for the intent of the clinical trial. It must be repeated as needed fir
the multiple sites. In the case of multiple sites, indicate the product released by each site.
Who is responsible in the Community for the release of the
finished IVP (please tick the appropriate box):
The site is responsible for release of (specify the IVP
concerned):
Manufacturer
Importer
Name of organization:
Address:
Person responsible for the study:
Name:
Address:
Tel number:
Fax number:
e-mail:
Please give the manufacturer or importer authorization number:
If no authorization, give the reasons:
Site inspected by EU authorities?
Yes
No
If yes, date of the last inspection:
5/12
Has the use of the investigational veterinary medicinal product been previously authorized
in a clinical trial conducted by the sponsor in the Community?
Yes
No
D 4. DESCRIPTION OF THE INVESTIGATIONAL VETERINARY MEDICINAL PRODUCT
Product Name, where applicable:
Product code, where applicable:
Name of each active substance (INN or
proposed INN if available, specify whether
proposed or approved INN):
Other available name for each active substance
(CAS, previous sponsor code(s), other
descriptive name etc (provide all available)):
ATCvet code, if officially registered:
Sponsor generated ATCvet code for the
indication studied in the trial, if applicable and
appropriate:
Pharmaceutical form (use standard terms):
Route of administration (use standard terms):
Strength (specify all strengths to be used):
Animal species:
Language of label(s) of IVP and CP:
Markets where the IVP is currently licensed:
MRL in Europe, if applicable:
Withdrawal period, if applicable:
Procedure of authorization
National Procedure
MRP/ Decentralized Proceedure
Centralized Procedure
Marketing Authorization Number
6/12
D 5. DESCRIPTION OF THE CONTROL VETERINARY MEDICINAL PRODUCT
Product Name, where applicable:
Product code, where applicable:
Name of each active substance (INN or
proposed INN if available, specify whether
proposed or approved INN):
Other available name for each active substance
(CAS, previous sponsor code(s), other
descriptive name etc (provide all available)):
ATCvet code, if officially registered:
Sponsor generated ATCvet code for the
indication studied in the trial, if applicable and
appropriate:
Pharmaceutical form (use standard terms):
Route of administration (use standard terms):
Strength (specify all strengths to be used):
Animal species:
Language of label(s) of IVP and CP:
Markets where the IVP is currently licensed:
MRL in Europe, if applicable:
Withdrawal period, if applicable:
Procedure of authorization
National Procedure
MRP/ Decentralized Proceedure
Centralized Procedure
Marketing Authorization Number
7/12
D 6. TYPE OF THE VETERINARY MEDICINAL PRODUCT
Does the investigational veterinary product contain an active
substance:
YES
NO
of chemical origin?
of biological/ biotechnological origin?
other
if other, please specify
an immunological veterinary medicinal product (such as vaccine,
allergen, immune serum)?
an homeopathetic medicinal product?
a veterinary medicinal product containing genetically modified
organisms?

If yes,

Has the authorization for contained use or release
been granted?

Is it pending?
another type of veterinary medicinal product?
If yes, specify
8/12
E 1. GENERAL INFORMATION ON THE TRIAL
MEDICINAL CONDITION OR DISEASE UNDER INVESTIGATION
Investigational Veterinary Products (IVP)
Company to dispatch the IVP to Cyprus
Control Veterinary Product (CVP)
Company to dispatch the control Veterinary Product
Location of storage of IVP and CVP in Cyprus
E 2. OBJECTIVE OF THE TRIAL
Main objective:
Secondary objectives:
E 3. SCOPE OF THE TRIAL (Tick all boxes, where applicable)
Diagnosis
Prophylaxis
Therapeutic
Safety
Efficacy
Pharmacokinetic
Pharmacodynamic
Bioequivalence
Dose Response
Pharmacogenomic
Pharmacoeconomic
Others
If others, specify
9/12
F. PROPOSED CLINICAL TRIAL SITES IN CYPRUS
F 1. COORDINATING INVESTIGATOR (FOR MULTICENTRE TRIAL) AND/ OR PRINCIPAL INVESTIGATOR (FOR
SINGLE CENTRE TRIAL) (REGISTERED VETERINARY SURGEON IN CYPRUS)
Name
Surname
Qualification
(DVM…………)
Address
Tel.:
Fax:
Email:
F 2. OTHER PRINCIPAL INVESTIGATORS (FOR MULTICENTRE TRIAL; WHERE NECESSARY, USE OTHER FORMS)
Name
Surname
Qualification
(DVM…………)
Address of the principal investigator
site
Tel.:
Fax:
Email:
Number of animals to be enrolled in the study
Number of animals to be treated with the Investigational Veterinary Product
Number of animals to be treated with the Control Veterinary Product
Study Duration
10/12
G. COMPETENT AUTHORITY CONCERNED BY THIS REQUEST
Name and address:
Date of submission:
Authorization:
If given, specify:
to be requested
pending
given
Date of authorization:
Authorization accepted
not accepted
If not acceptable, give:
-
the reasons:
-
the eventual anticipated date of resubmission:
11/12
I hereby confirm that
I hereby confirm on behalf of the sponsor that
(tick the correct box)

the above information given on this request is correct

the trial will be conducted according to the protocol, national regulation and the
principles of good clinical practice

I am of the opinion that it is reasonable for the proposed clinical trial to be
undertaken

I will submit a summary of the final study report to the Council of Veterinary
Medicinal Products, within a maximum of 1-year deadline after the end of the
study in all countries

I will declare the effective date of the commencement of the trial to the Council
of Veterinary Medicinal products as soon as available
APPLICANT of the request for the Council of Veterinary Medicinal Products (as stated in
section C):
NAME OF THE CONTACT PERSON:
ORGANIZATION:
DATE:
SIGNATURE:
12/12