WHAT DOCUMENT IS REQUIRED FOR THE TRANSFER OF DANGEROUS DRUGS FROM IMPORTER TO MANUFACTURER. IMPORTER TO DISTRIBUTOR, MANUFACTURER TO DISTRIBUTOR /WHOLESALER /TRADER, DISTRIBUTOR/ WHOLESALER/ TRADER TO RETAILER?  

For every transfer of dangerous drugs, a local purchase order permit duly approved by the Compliance Service, PDEA is required .

 

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WHAT IS REQUIRED SO THAT A PATIENT CAN PURCHASE A DANGEROUS DRUG’S PREPARATION FROM A PDEA LICENSED RETAIL OUTLET?

A Special DOH Prescription (yellow prescription ) issued by a current PDEA Licensed practitioner is required for a patient to purchase a dangerous drug’s preparation.

 

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CAN A PRACTITIONER WITH AN EXPIRED S-2 LICENSE PRESCRIBE DANGEROUS DRUGS &/OR PREPARATION/S?

No. The prescription becomes unlawful and the practitioner is liable to violation of Section 19, Article II, RA9165 which is punishable to life imprisonment to death and a fine ranging from Five hundred thousand pesos (Php500,000.00) to Ten Million pesos (PhP 10,000,000.00).

 

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IS IT NECESSARY FOR A DANGEROUS DRUG’S PREPARATION CONTAINING EITHER SCHEDULE III OF THE 1961 SINGLE CONVENTION AND SCHEDULE IV OF THE 1971 CONVENTION TO BE PRESCRIBED IN THE SPECIAL DOH PRESCRIPTION FORM (YELLOW PRESCRIPTION) ?

For tablet/capsule form , it is not required to be prescribed in the special DOH prescription form but through an ordinary personalized prescription in triplicate copy which contains the complete data required for a dangerous drug’s prescription. However, for injectable dosage form, it is required to be prescribed in the special DOH prescription form.

 

 

WHAT ARE THE REQUIREMENTS FOR THE IMPORTATION OF DANGEROUS DRUG’S PREPARATION/S OR CONTROLLED CHEMICAL/S?

 

For the importation /exportation of DANGEROUS DRUGS, DANGEROUS DRUG’S PREPARATION/S (DDP) AND/OR DRUG PREPARATION/S CONT’G TABLE I CONTROLLED CHEMICAL/S , the following are the requirements:

1. Applicant must be a legitimate import/export license holder of PDEA, validated by the LTH;

2. Letter request using the company’s stationery with letterhead addressed to the Director General PDEA, Attn.: Director, Compliance Service requesting approval for the intended importation. To be prepared by the authorized pharmacist;

3. Duly filled out typewritten Special Permit/Import Certificate/Export Declaration form;

4. Duly filled out application to import with attached proforma invoice/ purchase order, & Certificate of Product Registration (CPR) of the concerned DDP to be imported ;

5. Photocopy of Company’s Identification Card of the authorized pharmacist;

6. 2 X 2 ID picture of authorized pharmacist (for new authorized pharmacist only);

7. Import permit of the importer for the concerned shipment duly approved by the competent authority of the importing country. (FOR EXPORT ONLY)

For the importation /exportation of CONTROLLED CHEMICAL/S, the following are the requirements:

1. Applicant must be a legitimate import /export license holder of PDEA, validated by the LTH;

2. Letter request using company’s stationery with letterhead addressed to the Director General PDEA, Attn.: Director, Compliance Service requesting approval for the intended importation/exportation . To be prepared by the authorized signatory;
3. Duly filled out typewritten Special Permit /Export Declaration form;
4. Duly filled out application to import with attached proforma invoice/purchase order , Material Safety Data Sheet(MSDS) , & Affidavit re usage of concerned PECs;
5. Photocopy of Company’s Identification Card of the authorized signatory;
6. Photocopy of latest Semi-annual report received by this Office;
7. Import permit of the importer for the concerned shipment duly approved by the competent authority of the importing country. (FOR EXPORTONLY)
NOTE: Pertinent requirements to be submitted at least 15 days prior to transaction. (Sec.10, Art.III B.R. No. 3,S.2003.)

 

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WHAT ARE THE REQUIREMENTS IN SECURING A ‘CERTIFICATION” THAT A CHEMICAL/MIXTURE/DRUG PREPARATION/REAGENT IS INCLUDED OR NOT INCLUDED IN THE LIST OF CONTROLLED CHEMICALS OR DANGEROUS DRUGS?

 

the following are the requirements:

1. Letter of request addressed to the Director General , Philippine Drug Enforcement Agency from the importer. Attn.: Compliance Service;

2. Duly notarized affidavit attesting as to what the chemical/dangerous drugs is intended for;

3. Invoice/proforma invoice/ bill of lading/airway bill of the concerned shipment;

4. Certificate under oath duly notarized;

5. Photocopy of TIN of importer;

6. Material Safety Data Sheet (MSDS);

7. Photocopy of company identification card (front/back) of the responsible officer (importer) and authorized representative;

8. Payment of Certification fee in the amount of Php 150.00 per invoice.

Present the following to facilitate release of the Certification:

1. Receiving copy of the letter request;

2. Letter of authorization in favor of the representative to pick up the Certification;
3. Company ID of the authorized representative.

 

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WHAT ARE THE DUTIES OF A PDEA LICENSED OPERATOR/S OR ESTABLISHMENT/S?

 

The duties of a PDEA licensed operator/s or establishment/s are:

1. Renew PDEA license annually or every three years whichever is applied for. ( Sec.18, Art.III,B.R. No. 3,S. 2003 ;

2. Notify material change/s in relation to the grant of a license (Sec.19,Art. III, B.R.No.3,S.2003);

3. Check and notify suspicious order/s and transaction/s (Sec.21, Art.III,B.R. No.3,S.2003);

4. Licensed operator/s not to deal with unlicensed operator/s. (Se.22,Art.III,B.R.No.3,S.2003);

5. Keep or maintain original record of sales, purchases, acquisitions and deliveries, and submit semi-annual report of transactions .( Sec. 40, Art.III, RA9165 in relation to Sec.38(2 &3)Art.III,B.R. No.3,S.2003) penalized under Sec. 17 Art II , RA9165-;

6. Keep and maintain dangerous drugs register (Sec. 38 ,Art.III,B.R. No.3,S.2003)and controlled chemical register(Sec.39,Art.III,B.R.No.3,S.2003) and record transactions within 24 hrs.(Sec.38(8) and (Sec. 39(2),Art.III,B.R. No. 3,S.2003.);

7. Notify loss, destruction or discrepancies in registers.(Sec.42,Art.III,B.R. NO.3,S.2003);

8. Provide proper safekeeping of dangerous drugs and controlled chemicals (Sec. 43,Art.III,B.R. No.3,S.2003);

9. Notify loss, theft of dangerous drugs or controlled chemicals. (Sec.44,Art.III,B.R. No.3,S.2003);

10. Supplier/s of controlled chemical/s to ensure compliance of chemical containers to labeling and relabeling requirements.(Sec. 45,Art.III,B.R. No.3,S.2003;
11. Allow inspection of authorized premises, operation/s and checking of registers by duly authorized Regulatory Compliance Officer (Sec.47, Art.IV,B.R. No.3,S.2003;
12. Compelled to comply with the provisions of R.A. 9165 & other pertinent rules and regulations implemented by the Philippine Drug Enforcement Agency.

 

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