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PNF Form No. 4 - Exemption

This document contains a letter of request and proposal form for exempting a medicine from Administrative Order No. 163 s. 2002, which states that only medicines listed in the Philippine National Formulary (PNF) can be procured by government entities. The request includes a proposal form providing general information on the proposed exemption, justification for the exemption, details of risk-benefit and cost-effectiveness analyses comparing the proposed medicine to currently listed medicines for the same indication, and an evidence table. The request aims to exempt a specific medicine from the AO and have it eligible for government procurement.

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Ken Sanchez
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621 views

PNF Form No. 4 - Exemption

This document contains a letter of request and proposal form for exempting a medicine from Administrative Order No. 163 s. 2002, which states that only medicines listed in the Philippine National Formulary (PNF) can be procured by government entities. The request includes a proposal form providing general information on the proposed exemption, justification for the exemption, details of risk-benefit and cost-effectiveness analyses comparing the proposed medicine to currently listed medicines for the same indication, and an evidence table. The request aims to exempt a specific medicine from the AO and have it eligible for government procurement.

Uploaded by

Ken Sanchez
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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PNF FORM NO 4. LETTER OF REQUEST AND PROPOSAL FORM FOR EXEMPTION FROM A.O.163s.

2002

LETTER OF REQUEST

Date

Honorable ______________________
Secretary
Department of Health

ATTENTION: ____________________

Director
National Center for Pharmaceutical Access and Management
Department of Health

SUBJECT: Proposal to EXEMPT the medicine from A.O. No.163 s. 2002 that states that only
medicines listed in the PNF shall be procured by government entities.

Dear Secretary ___________________:

The (indicate name of DOH Unit/other party ) is requesting for the exemption of the following
medicine (indicate generic and brand name) from A.O. No. 163 s. 2002.

Please find attached two (2) hard and soft copies each of the following documents:

1. Accomplished proposal form;


2. FDA Certificate of Product Registration or WHO certification;
3. FDA-approved product information;
4. FDA certificate of good manufacturing practice;
5. Evidence Table including risk-benefit and cost-effectiveness analyses, where
applicable;
6. Report on disease burden and its ranking relative to the common diseases in the
community;
7. Other relevant documents ( e.g. clinical practice guidelines, excerpts from WHO
documents or other formularies, etc., including photocopies of such ).

We understand that incomplete submissions will not be processed.

( Indicate any additional remark )

Respectfully yours,
PROPONENT’S NAME
Designation
DOH Unit/ other Party’s Name
Indicate email address, telephone and facsimile number

PNF FORM NO. 4:


PROPOSAL FORM FOR EXEMPTION FROM A.O. No. 163 s. 2002

A. GENERAL INFORMATION ON PROPOSED EXEMPTION:

GENERIC NAME
BRAND NAME (if any)

THERAPEUTIC CLASSIFICATION
INDICATION
DOSAGE FORM/ STRENGTH
ROUTE OF ADMINISTRATION

DOSE, FREQUENCY AND DURATION OF


ADMINISTRATION
MANUFACTURER
IMPORTER/ TRADER
DISTRIBUTOR

B. SUMMARY OF JUSTIFICATON FOR EXEMPTION:

Please tick appropriate box/es: JUSTIFICATION AND REFERENCES

 Medicine has proven efficacy and


safety;
 Medicine will be used for national
health program;
 Medicine will be used for an urgent
health situation.

C. DETAILS OF RISK-BENEFIT ANALYSIS ( Attach Evidence Table )


CURRENTLY LISTED
PARAMETER PROPOSED MEDICINE MEDICINE FOR REFERENCES
SAME INDICATION
IN THE PNF

EFFICACY: CLINICAL
PERFORMANCE, OUTCOME
OF MEDICAL CONDITION

SAFETY AND TOLERABILITY

QUALITY OF LIFE

OTHERS (Indicate)

D. DETAILS OFCOST-EFFECTIVENESS ANALYSIS FOR NON-URGENT SITUATIONS ( Attach


Evidence Table )

NEW MEDICINE OR
PARAMETER PROPOSED CURRENTLY LISTED
(Indicate information for an INDICATION/ MEDICINE FOR REFERENCES
average adult male) * FORMULATION/ SAME INDICATION
ROUTEOF IN THE PNF
ADMINISTRATION

COST PER DOSAGE UNIT (in


PhP)

NUMBER OF DOSAGE UNITS


PER UNIT COURSE

TOTAL DIRECT COST PER


PATIENT PER TREATMENT
COURSE (in PhP)

ADDITIONAL COST PER


PATIENT PER TREATMENT
COST ( cost of drug
administration, monitoring,
additional diagnostic
services, additional
equipment, travel, caregiver
services, ADR treatment,
others ) (in PhP)

TOTAL COST PER PATIENT


PER TREATMENT COURSE (in
PhP)

EXPECTED NUMBER OF
PATIENT-TREATMENT
COURSES PER YEAR

QUALITY ADJUSTED LIFE


YEARS

DISABILITY ADJUSTED LIFE


YEARS

* Cost of medicine based on suggested retail price (SRP).

E. EVIDENCE TABLE (Please use PNF Form No.9 )

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