State Institute for drug control							Date:
Kvetná 11
82508 Bratislava
Slovakia

APPLICATION FORM FOR SCIENTIFIC ADVICE 
THROUGH THE STATE INSTITUTE FOR DRUG CONTROL

1) APPLICANT

Name of the company:
Address:

Name of the legal representative:
Address:

Telephone number:
Fax number:
Email address:

Name of the contact person:
Telephone number:
Fax number:
Email address:

2) PRODUCT

Name of the active substance:

Pharmaceutical form:

Proposed indication:

ATC code:

Type of the product:		□ chemical       □ biological	           □ herbal 

Proposed dispensing: 		□ subject to medical prescription
				□ not subject to medical prescription

Is product already marketed in any of the EU Member States?	□ yes, specify__________									□ no

Actual/proposed procedure to be followed for this product:		□ national
									□ mutual recognition
									□ decentralised
									□ centralised

3) SCOPE OF SCIENTIFIC ADVICE

Requested scientific advice concerns following topic(s):
□ Pharmaceutical quality
□ Non-clinical
□ Clinical
□ Pharmacovigilance/Risk management plan
□ Others, specify -------------------------------------------------

Justification for the request:

Has previously scientific advice been sought for this product?	□ yes		□ no

If so, please provide details and attach all advice received:

4) SIGNATURE OF LEGAL REPRESENTATIVE

Print name:							
Job title:      							___________________________      Date:         								           signature