WHAT ARE THE REQUIREMENTS IN THE APPLICATION OF P-1, P-3,
P-4, P-5C, P-5I, P-5E, P-5D, AND P-6 LICENSES?

 

REQUIREMENTS FOR RENEWAL APPLICATION ARE:

A. Current Mayor’s Permit with official receipt/ PEZA CERTIFICATE OF REGISTRATION (FOR ZONE LOCATORS ONLY);

B. DTI Certificate of Registration of Business Name/Securities & Exchange Commission Registration to include Article of Incorporation (AI) & Latest General Information Sheet (GIS);

C. Affidavit under oath attesting the specific legitimate use of the PECS &/or mixture/s in the company, its percentage & content, annual local purchase/importation/exportation/manufacture of PECS & supplier/s
and compliance to the law its implementing rules & regulations. For chemical mixture/s attach MSDS ;

D. NBI Clearance/s of either the Owner/ President/GM or BM(whoever is the head of the company) & authorized signatory. For foreigners-Alien Certificate of Registration/Alien Employment Permit or Passport;

E. Latest BOC CIIS Registration Certificate (for Importers/exporters);

F. Copy of latest Semi- Annual Report/ Annual/Record Book/Distribution Report;

G. Previous License to Handle (LTH) PECS &/or Official Receipt.

H. Company profile;

I. Organizational Chart with names of officers duly authenticated;

J. Floor Plan / lay-out indicating exact location where the controlled chemical/s is/are stored;

K. Location / Vicinity map of the company/ establishment;

L. Front view pictures of the company/establishment showing the signage & storage area w/ two(2) security locks;

M. One(1) 2 X 2 ID picture and (3) specimen signatures of either the Owner /Pres / GM or BM/ (whoever heads the company) & authorized signatory;

N. Proof of ownership of the land/building where establishment/company is located contract of lease;

O. BFAD LICENSE to OPERATE with current official receipt (for Pharmaceutical firms);
P. DENR-EMB EEC- ( for Manufacturers )

 

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WHAT ARE THE REQUIREMENTS IN THE APPLICATION OF S-2 LICENSE?

 

THE FOLLOWING ARE THE REQUIREMENTS:

A. Updated Professional Regulation Commission (PRC)Card;

B. Current Professional Tax Receipt (PTR). For government practitioner, latest certificate of employment, and Affidavit duly notarized that the S-2 license will be used exclusively for government patients and not for his/her private practice;

C. TIN or ITR;

D. Drug Test Result of DOH accredited testing center;

E. Two (2) 1 X 1 ID pictures with name tag taken not later than a month from application, no eyeglasses;

F. Previous S-2 Card which will be surrendered .(Renewal application).

THE PRACTITIONER APPLICANT IS REQUIRED TO APPLY PERSONALLY

AUTHORIZED REPRESENTATIVE IS NOT ALLOWED

 

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WHAT IS THE VALIDITY OF A PDEA LICENSE?

A PDEA license issued to a handler of DD, DDP/s , Table I Controlled Chemical/s &/or DP/s, PECS &/or mixture/s shall remain valid for a period of one year . For a practitioner, the S-2 license is renewable for a period of three(3) years and shall remain in force for said period.

 

 

IS THERE A VIOLATION IF A LICENSED OPERATOR DEALS WITH UNLICENSED OPERATOR?

Yes, there is a violation pursuant to Section 32, Article II of RA9165 in relation to Section 22 of Board Regulation No.3, Series 2003. It is punishable with imprisonment ranging from six(6) months and one (1) day to four (4) years and a fine ranging from Ten thousand pesos (PhP 10,000.00) to Fifty thousand pesos (PhP50,000.00).

 

 

WHAT ARE THE STEPS IN THE APPLICATION OF A PDEA LICENSE?

 

THE FOLLOWING ARE THE STEPS IN APPLYING FOR A PDEA LICENSE:

1. For handlers of DD/DDP/s/ Table I Controlled Chemical/s used in the manufacture of drug preparation/s &/or DP/s / PECS &/or mixture/s-

  • Fill out Application Form completely. Type or print legibly. ONLY SIGNED FORMS WITH COMPLETE DOCUMENTS WILL BE PROCESSED;
  • Submit Application Form with original & clear photocopies of requirements in a folder properly labeled with tabs & fastened, to the duty officer at the Compliance Service (CS), PDEA (Rm 213) for evaluation /processing;
  • New Applicant will be subjected to Physical Security Inspection (PSI) -
    • C.1 Secure inspection fee assessment of payment from duty officer.
    • C.2 Pay inspection fee in the amount of Php 500.00 to be duly receipted at the cashier’s office of DDB located at the 3 rd Floor of PDEA Bldg. in cash or check or Postal Money Order (PMO) payable to Dangerous Drugs Board (DDB).Regional/personal checks are not acceptable;
    • C.3 For Metro Manila applicants- Request for inspection date when the PSI will be conducted at CS, PDEA;
    • C.4 For regional P-license applicants- Application will be transmitted to PDEA regional office where company/establishment is located. Ask for regional referral ;
    • C.5 Site inspection will be conducted by Regulatory Compliance Officer/s /Inspector/s, and the result of the inspection /recommendation of the inspector/s will determine the approval of the applied license;
  • For approved license- Secure assessment of payment from duty officer at CS, PDEA;
  • Payment of the appropriate license fee is paid at the DDB cashier’s office to be duly receipted;
  • Present official receipt to the duty officer for notation at CS, PDEA; and
  • Claim License to Handle (LTH) DD/DDPs/PECS.

2. For practitioners of DD/DDP/s &/or DP/s cont’g Table I controlled chemical/s-

  • Fill out Applcation Form completely. Type or print legibly. ONLY SIGNED FORMS WITH COMPLETE DOCUMENTS WILL BE PROCESSED;
  • Submit Application Form with original & clear photocopies of requirements to duty officer at CS, PDEA;
  • Application will be processed by duty officer;
  • Secure assessment of payment ;
  • Pay the assessed license fee at the DDB cashier’s office to be duly receipted;
  • Present official receipt to duty officer for notation;
  • Claim S-2 Card.

 

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WHAT ARE THE THRESHOLDS FOR TABLE II CONTROLLED CHEMICAL/S THAT CAN BE SOLD TO A REGULAR OR KNOWN CUSTOMER IN A MONTHLY BASIS THAT WILL NOT REQUIRE PRESENTING A PDEA LICENSE?

 

The following are the prescribed thresholds:

SINGLE COMPONENT CHEMICAL TOTAL
ACETONE 1 liter
HYDROCHLORIC ACID 25 liters
SULFURIC ACID 25 liters
ETHYL ETHER 1 liter
TOLUENE 1 liter
METHYL ETHYL KETONE 1 liter

CHEMICAL MIXTURE/SOLUTION

 AGGREGATE
Cont’g ACETONE 5 liters
Cont’g HYDROCHLORIC ACID 50 liters
Cont’g SULFURIC ACD 50 liters
Cont’g ETHYL ETHER   5 liters
Cont’g 30% TOLUENE   20 liters
Cont’g 30% METHYL ETHYL KETONE   5 liters

 

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WHAT ARE THE REQUIREMENTS RELATIVE TO THE SALE OF TABLE II CONTROLLED CHEMICAL THAT FALLS WITHIN THE PRESCRIBED THRESHOLD ABOVE?

 

The following are the requirements involving the sale of Table II Controlled Chemical that falls within the prescribed threshold above:

1. The licensed seller shall ask the customer for any identifying document such as driver’s license, office or voter’s identification and signature of the individual;

2. Purchased controlled chemical shall not be resold by the purchaser;

3. Table II Controlled chemical shall not be sold to minors who are less than eighteen (18) years of age without the written consent of his/her parents or guardian or sold for the purpose of abuse;

4. Transaction will be recorded by the licensed seller in a record book /register, which is subject to inspection at any reasonable time by PDEA Regulatory Compliance Officer;

5. Transaction will be for legitimate use by the purchaser and not for resale.

 

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