F 180b
ÚSTAV ŠTÁTNEJ KONTROLY VETERINÁRNYCH BIOPREPARÁTOV A LIEČIV
Institute for State Control of Veterinary Biologicals and Medicaments
949 01 Nitra, Biovetská 34
Tel.: +421/37/6515 506-7
Fax: +421/37/6517 915
IČO: 31 873 154
www.uskvbl.sk
email: uskvbl@uskvbl.sk
DIČ: 202127037
APPLICATION FOR AN APROVAL OF VETERINARY CLINICAL TRIAL SITE
According to §78, section 2 of Act No. 362/2011 Coll., on drugs and medical devices and the decree of MPRV
SR 196/2012 Coll.
APPLICANT
Legal person:
Commercial name:
Residence:
Authorised person:
Name and Surname
Permanent address:
Organisation Identif. No.
(IČO):
Name and Surname:
Natural person:
Permanent address:
Commercial name:
Name and Surname:
Contact information of the
Telephone:
applicant:
Fax:
Email:
VETERINARY INVESTIGATOR (Person responsible for the vet. clinical trial)
Name and Surname
Education
MONITOR OF THE VET. CLINICAL TRIAL (Person responsible for specialized supervision)
Meno a priezvisko
SCOPE OF THE VET. CLINICAL TRIAL characterized by the pharmacotherapeutic type of the investigated vet.
products or medicine:
VETERINARY CLINICAL TRIAL SITE, where the vet. clinical trial will be conducted
Name
Address
APPENDICES TO THE APPLICATION
The copy of the Trade Certificate or the Certificate of incorporation (no older than 3 months)
Evidence of a Lease agreement or Proof of property of the premises, where the vet. clinical trial will be
conducted
An affirmative finding of the respective RVPS of the premises, where the vet. clinical trial will be conducted
The Proof of qualification of the person responsible for the vet. clinical trial (veterinary investigator)
Statement of the applicant that the vet. clinical trial site complies material, space facilities (lockable premises
with a cooling device, that are suitable for storing of the vet. investigated products or vet. invatigated drugs) and
staffing for the implementation of the vet. clinical trial meets the requirements for good clinical practice.
OTHER APPENDICES:
I declare that all of the information in the application and appendices are true.
Date:
Signature of the Applicant (for legal entities legal representative)
(name, stamp and signature )