GOVPH

According to the Philippine Food and Drug Administration (FDA, formerly BFAD), any foreign organization intending to bring medicines and/or medical equipment to be donated or used during the conduct of medical missions must comply with the requirements of the Department of Health’s Bureau of International Health Cooperation (DOH-BIHC).  DOH-BIHC shall then facilitate the issuance of a clearance from the FDA and the Bureau of Health Devices and Technology (BHDT) for the drugs, medical supplies and medical equipment, as the case may be.

REQUIREMENTS:

1. All applications for Foreign Surgical and Medical Missions (FSMM) shall be submitted to the Philippine Medical Association (PMA) who shall forward the same to the following professional groups copy furnished DOH.  Click here to download application form (from PMA website, www.philippinemedicalassociation.org).
2. Each member of the foreign medical team must submit the following documents in applying for temporary license to practice during the duration of the mission.  All documents must be in English or with English translation:

a. Valid/current license from country of origin, authenticated by the Embassy/Consulate (please refer to Authentication procedures and requirements in the list of Consular Services)

b. Board certification (specialty), authenticated by the Embassy/Consulate (please refer to Authentication procedures and requirements in the list of Consular Services)

c. Curriculum vitae, acknowledged by the Philippine Embassy/Consulate (please refer to Authentication procedures and requirements in the list of Consular Services)

d. Passport sized picture in four copies (taken within one year)

e. Application letter addressed to the President of PMA to contain the following information:

- Type of mission (medical, surgical or both)

- Duration of the mission and inclusive dates

- Names and specialties of the mission team members

- Written consent from the host local government executive (governor/mayor) and/or of the health facility where the mission will be conducted

f. The following are additional requirements if the foreign mission team members intend to bring drugs, and/or medicines, medical supplies and medical equipment to be donated or used during the mission:

- Itemized list of the items together with the quantity and the expiration dates for drugs and medicines

- Flight details

- Deed of donation authenticated at the country of origin (please refer to Authentication procedures and requirements in the list of Consular Services)

- Deed of acceptance from the host hospital/Local Government Unit (LGU)

- Drugs and medicines to be donated should have a shelf life of at least 12 months upon arrival in the country and the said medicine shall be used solely for the scheduled mission.

- Application must be submitted 60 days before the date of mission to facilitate clearance/s from DOH and other agencies.

g. Letter of certification from the sponsoring host organization (LGU or Non-Government Organization (NGO)) certifying the need and type of mission to be conducted.  Cost of post-care mission of morbidities/mortalities arising from the mission will be shouldered as well by the host organization.

h. Proof of juridical entity (certified true copy of the Securities and Exchange Commission (SEC) registration must be submitted.

i. Notarized letter of guarantee from both the medical mission group and the host organization assuming full responsibility for the outcome of the missions.

3. The PMA, upon receipt of all requirements, will forward the application to the concerned specialty societies for evaluation of credentials.  The DOH will be informed immediately of the presence of drugs, medical supplies and medical equipment.

4. The DOH shall facilitate issuance of clearance by its FDA and BHDT for the above mentioned goods.

5. After the evaluation of the missioner's credentials by the concerned Specialty Society, the PMA shall send a letter of endorsement to DOH.

6. The DOH shall then endorse the documents to Professional Regulation Commission (PRC).

7. The PRC, after final review, shall issue the Special Temporary Permit to Practice to concerned foreign missioners.

8. The lead time for the processing of the application are as follows:

• PMA - 2 weeks before the mission date
• DOH - 1 week before the mission date
• PRC - 3 weeks before the mission date

9. Post-mission report shall be submitted by the head of the foreign surgical and/or medical missions, concurred/noted by the President of the local component society of PMA, and/or specialty society and the LGU concerned, to the oversight agencies (DOH, PMA, PRC) 15 days after the completion of the mission.  All records and audio-visual documents must also be submitted in triplicate form.  The post-mission report should contain the following minimum basic information:

• No. and age of cases seen
• Diagnosis of patients
• List of medicines distributed and surgical interventions done
• Endorsements to the necessary health facilities (follow-up, further evaluation and management)
• Morbidities and mortalities, if any

10. All materials submitted to the oversight agencies shall be the property of the Philippine counterpart and may not be used for advertisement, solicitation or medical publication without the written and expressed approval of the local medical society and/or specialty society of the PMA and the local counterpart.  Any intellectual output as journal or publication must include the local physicians as senior authors.

11. Former Filipino Registered Health Professionals who are part of a Medical/Surgical Mission Team may practice their profession in the Philippines upon presentation of proof of valid and current PRC licenses.  Otherwise, they have to renew their licenses upon submission of the following requirements (Presidential Decree No. 541):

• Photocopy of current/valid passport (page 1 and the page showing the date of arrival in the Philippines)
• Photocopy of PRC license and valid certificate of registration
• License/Certificate of Registration in the adopted country or Certification of employment with letterhead indicating the job description within the definition of the applicant's profession
• Four pieces of recent passport size pictures (taken within one year)
• Payment of prescribed fees at PRC
• Certificated of training and board certification (for specialists)
• Application for Temporary Special Permit (PRC form 103-A)

12. Foreign Religious groups/missionaries practicing medicine in the country shall abide by the same requirements and adhere to the guidelines.  These missioners who serve for longer period of time shall signify their intention to continue living in the Philippines to pursue missionary works.  They shall secure Special Temporary Permit, which is to be renewed annually.  The following must be submitted:

• Certification for their congregation that the medical works are purely for charity purposes and with no remuneration involved whatsoever.
• A certification from the congregation assuming the responsibility for any action of the said physician
• The missionary should submit to PMA an annual mission report including a list of patients treated
• The missionary is required to attend PMA or component societies' Continuing Medical Education (CME) related activities once a year to update their medical knowledge.
• The missionary who conducted his missionary works in the province must coordinate with the PMA component society for proper identification and monitoring.

According to the DOH-BIHC, the Commission on Filipinos Overseas (CFO) may be contacted to assist organizers of foreign medical missions.  The CFO’s contact details are:

Commission on Filipinos Overseas
Citigold Center, 1345 President Quirino Avenue,
Corner South Superhighway, Manila
Telephone Nos. (632) 561-8327, 552-4701
Fax No. 561-8332
Mobile Nos. (+63) 9175630773 / (+63) 9175630782
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

The DOH’s Revised Policies and Guidelines in the Conduct of FSMM may be found atwww.doh.gov.ph (click on Doing Business > Medical Missions).

Below is the DOH’s complete text on the Procedural Guide for Shipping Medicines/Drugs for Medical Missions.

Pursuant to item VII, No. 3 (f) of the Joint Administrative Order No. 2009-0030, of the DOH, the PRC, and the Department of Interior and Local Government (DILG), the following are additional requirements if the foreign mission team members intend to bring drugs, and/or medicines, medical supplies and medical equipment to be donated or used during the mission:

• Itemized list of the items together with the quantity and the expiration dates for drugs and medicines
• Flight details
• Deed of donation authenticated at the country of origin
• Deed of acceptance from the host hospital/Local Government Unit
• Drugs and medicines to be donated should heave a shelf life of at least 12 months upon arrival in the country and the said medicine shall be used solely for the scheduled mission
• Application must be submitted 60 days before the date of mission to facilitate clearance/s from DOH and other agencies

With regard to the entry of drugs which need to be regulated by the Philippine Drug Enforcement Agency (PDEA), please refer to the PDEA’s website at www.pdea.gov.ph.

Please be also informed that the donated medicines are subject to duties and taxes.  These shall only be exempted from duties if these are consigned to government and private (primary and secondary) hospitals duly licensed to operated by the DOH, and welfare/relief dispensing organizations/agencies registered and/or accredited by the Department of Social Welfare and Development (DSWD) and registered with the SEC.  Even if the donation is exempted from duties, it will still be subject to Value-Added Tax (VAT), which is computed at twelve percent (12%) of the total cost of shipment.

In securing duty-free clearance, the following documents must be submitted to the National Economic and Development Authority (NEDA) and the Department of Finance (DOF):

A. From the Donor:

1.      Deed of Donation duly authenticated by the Philippine Embassy or Consulate;

2.      Packing list of donated items.  If medicines would be included in the shipment, kindly submit the itemized list of drugs and quantity to be donated indicating brand/generic name, dosage forms/strengths, batch/lot number, expiration date of at least one (1) year upon receipt, and name/address of the manufacturer; and

3.      Shipping Documents (i.e. bill of lading).  The original copy will be needed by the consignee/local counterpart in processing the release of donation.

B. From the Donee/Consignee:

1.      Letter to the DOH-BIHC requesting endorsement to the FDA for the issuance of clearance.

2.      The letter request should be submitted with the complete list of drugs and quantity to be donated, with the following information: brand/generic name, formulation (with English translation), dosage forms/strengths, batch/lot number, expiration date of at least one (1) year upon receipt, and name/address of the manufacturer.

3.      Letter to the NEDA and DOF requesting for the issuance of duty-free clearance for the donation;

4.      Duly notarized Deed of Acceptance;

5.      Distribution plan for medicines;

6.      Current and valid DOH License to Operate, if hospital

7.      DSWD License to Operate and Certification of Accreditation, if non-government organization; and

8.      FDA Certificate of Product Registration (for medicines)

The donee/consignee in the Philippines may apply for the clearances for the donated items.  It is important that the name listed as donee/consignee in the deed of donation must be the same as that appearing in the shipping documents.

We suggest that the shipping of any donation to the Philippines should be withheld unless prior coordination with the donee/consignee has been made, and appropriate endorsements/clearances from government agencies have been secured.