ISSUANCE OF DANGEROUS DRUGS LICENSE (S-LICENSE, non practitioner)

Schedule: Monday to Friday – 8AM to 5:00PM

License Type Category Annual Fee

S-1 License to sell, procure, acquire, deal in or with specified drug preparations,containing controlled chemical for retail, P 500.00
(Retailer) except drug preparation containing Norephedrine / Phenylpropanolamine at doses 25 mg or below [OTC drugs, per BFAD
AO 163, s. 2000].
S-3 License to sell, procure, acquire, deal in or with specified (a) dangerous drugs preparations in any form; or, (b) drug P 1,000.00
(Retailer) preparations containing controlled chemical for retail, except drug preparation containing Norephedrine /
Phenylpropanolamine at doses 25 mg or below [OTC drugs, per BFAD AO 163, s. 2000]. Covers activities granted to S-1
License Holders.
S-4 License to sell, procure, acquire, deal in or with specified (a) dangerous drugs and their preparations in any form; (b) drug P 3,000.00
(Wholesaler) preparations, containing controlled chemicals for wholesale distribution to license holders, except drug preparation
containing Norephedrine / Phenylpropanolamine at doses 25 mg or below [OTC drugs, per BFAD AO 163, s. 2000]; and (c)
controlled chemicals used in the manufacture of drugs preparations The license holder need not obtain another license
of the same nature of activity for such controlled chemicals.
S-5C License to manufacture specified (a) dangerous drugs and their preparations in any form; and (b) drug preparations P 5,000.00
(Manufacturer) containing controlled chemicals provided, that the license shall not apply to the compounding and filling of prescription in
drugstores, clinics and hospitals. The license holder need not obtain another license of the same nature of activity for such
controlled chemicals. May engage in wholesale distribution of that substance or class for which license was issued; may
not distribute any substance or class for which it is not licensed. May conduct chemical analysis and quality control
analysis with those substances for which license as a manufacturer was issued. May procure, acquire scientific apparatus
or controlled laboratory equipment for manufacture of drugs. A controlled substances trader shall be categorized as a
manufacturer.
S-5D License for bulk depot/storage of specified dangerous drugs and their preparations in any form; (b) drug preparations P 5,000.00
(Bulk Depot / containing controlled chemicals except drug preparation containing Norephedrine / Phenylpropanolamine at doses 25
Storage) mg or below [OTC drugs, per BFAD AO 163, s. 2000].; (c) controlled chemicals used in the manufacture of drug
preparations; and when such address is separate and distinct from the office address of the license holder.
S-5E License to export specified (a) dangerous drugs and their preparations in any form; and/or (b) drug preparation containing P 5,000.00
(Exporter) controlled chemicals : to foreign license holders.
S-5I License to import specified (a) dangerous drugs and their preparations in any form; (b) drug preparations containing P 5,000.00
(Importer) controlled chemicals, except drug preparation containing Norephedrine / Phenylpropanolamine at doses 25 mg or below
[OTC drugs, per BFAD AO 163, s. 2000]; (c) controlled chemicals used in the manufacture of drugs preparations; and, (d) in
vitro diagnostic reagents, buffers and analytical standards, test kits containing dangerous drug. The license holder need
 not obtain another license of the same nature of activity for such controlled chemicals. May engage in wholesale
distribution of that substance or class for which license was issued; may not distribute any substance or class for which
not licensed].
S-6 License to conduct laboratory analysis or technical research or instructional / training program, using controlled P 500.00
(Research/Analysis/ substances or drugs containing controlled chemicals or plant sources of controlled substances. May procure, acquire
Instructional syringe, scientific apparatus or laboratory equipment
program)

WHAT ARE THE REQUIREMENTS? (*Original current document required. For the rest of the requirements, submit clear photocopy and present original for validation)

NEW APPLICANT RENEWAL APPLICANT

1. TIN Card/ Latest ITR (Head of Office & Authorized Pharmacist) 1. NBI Clearance (Authorized Pharmacist)
2. NBI Clearance (Head of Office & Authorized Pharmacist) 2. *Letter of Authorization, PDEA format
3. *Letter of Authorization, PDEA format 3. *Notarized Joint Affidavit, PDEA format
4. *Notarized Joint Affidavit, PDEA format 4. PRC ID Card (Authorized Pharmacist)
5. PRC ID Card (Authorized Pharmacist) 5. PTR (Authorized Pharmacist)
6. PTR (Authorized Pharmacist) 6. DTI/ SEC/ CDA Certificate
7. TIN Card/ Latest ITR (Company) 7. General Information Sheet –GIS (corporations only)
8. DTI/ SEC/ CDA Certificate 8. Business/Mayor’s Permit
9. General Information Sheet –GIS (corporations only) 9. FDA or DOH-CHD LTO Certificate with official receipt
10. Business/Mayor’s Permit 10. BOC Accreditation Certificate(importer/exporter only)
11. FDA or DOH-CHD LTO Certificate 11. *Projection for forthcoming year (importer/ manufacturer only)
12. BOC Accreditation Certificate(importer/exporter only) 12. Certificate of Product Registration –CPR (importer/ manufacturer/ exporter
13. *Projection for forthcoming year (importer/ manufacturer only) only)
14. Certificate of Product Registration –CPR (importer/ manufacturer/ exporter 13. Latest Semi-Annual Report Submitted
only) 14. *Record Book / Register with updated recording
15. Picture of DDPs/ Box Label/ Package Insert (importer/ manufacturer/ 15. *Latest S – license issued (for surrender)
exporter only)
16. Company profile
17. Organizational structure, certified correct and current by Human Resource
(HR) Officer of company with pictures of head and authorized pharmacist
18. Location/Vicinity Map
19. Floor plan/ Layout to highlight controlled drug storage area
20. Picture of Drug Establishment (façade)
21. Picture of controlled drug storage area
22. Proof of ownership/ Lease of Contract
HOW TO APPLY? (NEW APPLICANT)
DURATION OF PERSON IN
STEP APPLICANT/ CLIENT ACTIVITY FEES
ACTIVITY CHARGE
1 Submit completely filled-out application Receive and check application with requirements. Interview. 30 minutes DDRO II -
form (SLA-09) and arrange all Encode information in database. Print/issue assessment slip.
requirements consecutively and neatly in
a long color-coded folder:
S License Application – Green
Multiple License Application – Yellow

2 Pay Inspection Fee Issue Official Receipt. - DDB Cashier PhP 500.00
3 Submit duly noted assessment and Encode O.R. # in database. 5 minutes DDRO II -
present Official Receipt.
4 Signify preferred date of inspection. Schedule date of inspection. Assign inspector. 5 minutes DD, CS -
Print/issue Inspection Order. Provide copy to client.

5 Accompany inspector on scheduled Conduct Physical Security Inspection (PSI) and orientation on 1 hour exclusive DDRO / RCO -
inspection date. scheduled date. of travel time
Sign in the PSI report to signify Provide client with copy of PSI Report.
concurrence and acknowledgement.
Submit report to D,CS through C, LRD within 3 days from date
of inspection.

6 Report to PDEA 3 days after inspection Retrieve application folder with noted report from CS Records 15 minutes DDRO II -
date Officer. Check if approved or otherwise. Require submission
of lacking requirement, if any. Issue assessment slip.

7 Pay License Fee Issue Official Receipt - DDB Cashier 500.00(S1)/yr

1,000.00(S3)/yr
3,000.00(S4)/yr
5,000.00(S5C)/yr
5,000.00(S5D)/yr
5,000.00(S5E)/yr
5,000.00(S5I)/yr
500.00(S6)/yr
 8 Submit duly noted assessment and Encode O.R. # in database. 10 minutes DDRO II -
present Official Receipt. Re-orient authorized pharmacist on regulatory control, if
Receive claim slip/temporary license. necessary. Issue claim slip/temporary license and CS advisory.

Batch print licenses. Within 10 Admin Asst -

working days

9 Claim license on specified date. Receive and check claim slip. Require submission of lacking 10 minutes RO -
Submit claim slip requirement, if any. Note released license in designated
logbook. File application folder.
END TRANSACTION
A SEPARATE PERMIT APPROVAL IS NECESSARY PRIOR TO IMPORT/EXPORT/MANUFACTURE/LOCAL TRANSFER OF DD/DDPs, UNLESS SPECIFICALLY EXEMPTED.

HOW TO APPLY? (RENEWAL APPLICANT)

Please refer to Steps 1, 7, 8 and 9 above.