Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

January 28, 2021

DEPARTMENT MEMORANDUM
No. 2021- 0053

FOR: ALL UNDERSECRETARIES AND ASSISTANT

SECRETARIES; DIRECTORS OF BUREAUS AND
CENTERS FOR HEALTH DEVELOPMENT; MINISTER
OF HEALTH BANGSAMORO AUTONOMOUS REGION
—-

IN MUSLIM MINDANAO; EXECUTIVE DIRECTORS OF

SPECIALTY HOSPITALS AND NATIONAL NUTRITION
COUNCIL; CHIEFS OF MEDICAL CENTERS,
HOSPITAL, SANITARIA AND INSTITUTES; PRESIDENT
OF THE PHILIPPINE HEALTH INSURANCE
CORPORATION; DIRECTORS OF _PHILIPPONES
NATIONAL AIDS COUNCIL AND TREATMENT AND
REHABILITATION CENTERS AND OTHERS
CONCERNED

SUBJECT: Interim Guidelines on the Shipment and Acceptance

COVID-19 Vaccines and Ancillary Immunization
of the
Commodities

I. INTRODUCTION

The initial
supply of the COVID_19 Vaccines for the Government of the Philippines
is expected to be available on late February or early March 2021. This limited supply
shall be used in the identified areas based on certain criteria and will be administered
to the priority eligible population.

This interim guideline is issued to establish the processes/activities to be followed as

soon as the COVID-19 vaccines has been procured from the pre-shipment, during
delivery and the acceptance of the vaccines and ancillary immunization commodities
to the Central Cold Storage Facility and Warehouses. Other relevant guidelines shall
be issued as necessary as new information shall be available.

Building 1, San Lazaro Compound, Rizal Avenue, Sta. Cruz, 1003 Manila e Trunk Line 651-7800 local 1108, 1111, 1112, 1113
Direct Line: 711-9502; 711-9503 Fax: 743-1829 @ URL: http://www.doh.gov.ph; e-mail: ftduque@doh.gov.ph
I. SPECIFIC GUIDELINES

1. COVID-19 VACCINES .

a. Pre-shipment of the Vaccines: The procuring entity shall notify the vaccine
_manufacturer and submit the following documents to:

1)Food and Drug Authority:

1.1 All the documents required as listed in the FDA Circular 2020-036
on the Guidelines on the Issuance of the Emergency Use
Authorization for Drugs and Vaccines for COVID-19.
2) Bureau of International Health Cooperation (BIHC)
2.1 All pre alert documents shall be submitted 10 days prior to departure
from origin:
2.1.1 Memorandum / Loan Contract Agreement duly signed by
both parties
2.1.2 Bull of Lading /Airway Bill
2.1.3. Commercial Invoice
2.1.4 Packing List
2.1.5 Batch Release Certificate
2.2 Submitted documents shall be forwarded to Management Support
Division of the Supply Chain Management Service (MSD-SCMS)
for review and to check the correctness of details before
submission to the DOH accredited broker.

Such other documents peculiar to the contract and /or the mode of
Agreement and considered necessary in the auditorial review and
in the technical evaluation thereof.

3) Upon arrival, MSD-SCMS will do the following;

3.1 Issuance of authorization letter to DOH accredited Broker for the
processing and release of the shipment.
3.2
3.3
Authorize the DOH accredited broker for LODGMENT of shipment.
Preparation of undertaking documents for Duties and Taxes to be
signed by both SCMS Director and Budget Division Chief for
submission to Bureau of Customs and exemption documents for
Departmentof Finance (DOF).
3.4 Facilitate the signing of BOC documents such as BOC Single
Administrative Document and Revise Declaration on Valuation for
submission to BOC.
3.5 Conduct follow-ups and monitoring of shipment from all concerned.
3.6 Assist in Requesting for Schedule of Delivery.
b. Consignee of the Commodities: The consignee of the COVID Vaccines shall
strictly be:

THE DEPARTMENT OF HEALTH

SAN LAZARO COMPOUND, RIZAL AVENUE
STA.CRUZ, MANILA 1003
PHILIPPINES

Cc. Pre-delivery:
1) The Supplier of the vaccines shall apply for the Request for Delivery (RSD)
and submit the requirements as per attached Checklist at the Supply Chain
Management Service (SCMS) —Department of Health (DOH) entity as
required by the Food and Drug Administration (FDA) days before delivery
to the assigned cold storage facility/warehouse.
2) Approval of the RSD shall be by the Director of the Supply Chain
Management Service as per recommendation of the Division Chief,
Warehouse and Distribution Division (WDD) of the SCMS.
3) SCMS shall inform the supplier of the approval and shall be requested to
provide the following details through the email address
scms.officeofdirector@gmail.com.
3.1 Vehicle Plate Number
3.2 Names of the Driver, Assistants/Helpers
4) WDD-SCMS shall inform the:
4.1 Pharmacist or Cold Storage/Warehouse In-Charge of the RSD and other
pertinent information. This is to prepare the space requirement for the
incoming vaccines.
4.2 Philippine National Police (PNP)/ Armed Forces of the Philippines
(AFP) of the schedule delivery for security.

d. During Delivery at the Cold Storage Facility:

1) Supplier submits the signed RSD and other documents listed in the RSD
2) The Supplier/Distributor shall submit the following documents if vaccines
are delivered to RITM
2.1 Purchase Order
2.2 Notice to Proceed
2.3 Notice of Award
2.4 Certificate of Delivery
2.5 Certificate of Analysis
2.6 Certificate of Product Registration (CPR)
2.7 Lot Release Certificate
if
available

2.8 Request Schedule of Delivery

2.9 Safety Data Sheet
2.10 Delivery Receipt/Proof of Delivery
2.11. Invoice Receipt/Commercial Invoice or Equivalent
3) Pharmacist and/or the Warehouse in-charge shall
 3.1 Review the completeness of the submitted documents
3.2 Pre-inspect the delivered vaccines in the presence of the Representatives
from the Supplier, Hauler, Procuring Entity and other identified
authorized Representatives. Pre-inspection shall be based on the
Technical Specifications as indicated in the Purchase Order (PO).
3.3 Check the data logger in every box, print and analyze for any
temperature deviation from the recommended temperature requirements
as specified in the product literature/technical specifications during
transport and storage
3.4 Report any deviation on the temperature requirements, purchase order
or contract and other observations a soon as possible (ASAP) to the
Director of the SCMS and Undersecretary of the Procurement and
Supply Chain Management Team (PSCMT) for appropriate action.
3.5 Document all the processes/activities

4) If the pre-inspected commodities are in accordance with the requirements

and in good physical conditions upon inspection, the pharmacist/ warehouse
in-charge shall put-away the vaccines for storage and shall be marked as
“QUARANTINE”.
5) Requests for visits to cold storage facilities by other interested parties
stating their purpose shall be referred to PSCMT for
approval.

Inspection and Acceptance:

The Inspection and Acceptance Committee (IAC) for the COVID-19 shall:

1) all the vaccines marked as “QUARANTINE”.

Inspect
2) Retain 5-10 vials per lot/batch for future use/testing in case there are adverse
effect after vaccination among others.
3) Submit the inspection and acceptance report immediately upon completion
of the activity
4) Report any deviation based on the contract or PO and other observations a
soon as possible (ASAP) to the Director of the SCMS and Undersecretary of
the Procurement and Supply Chain Management Team (PSCMT) for
appropriate action.
5) “QUARANTINED’ vaccines accepted shall be marked as “GOOD” and
shall now be processed and entered into the current cold storage /warehouse
logistics information management system as to the details of the vaccines and
other pertinent data required such as but not limited to:
5.1 Item Description
5.2 Quantity
5.3 Batch/Lot Number
5.4 Manufacturing and Expiry Date
5.5 Unit Cost
5.6 Source (Supplier and P.O./Contract Number)
5.7 Quantity per Secondary Packaging, if applicable
—
5.8 Dimension of Secondary Packaging in cm, ifapplicable
5.9 Location of the Put-Away Item in the Locator Map

6) “QUARANTINED” vaccines rejected shall be marked as “REJECTED and

RETURN TO SUPPLIER”.
7) SCMS shall inform the supplier and schedule the pull-out of the rejected
commodities.

2. ANCILLARY IMMUNIZATION COMMODITIES Other ancillary immunization

commodities to be used during the COVID-19 vaccination shall follow the same process as
in the vaccines except for the temperature requirements.

3. Distribution of the COVID -19 vaccines and ancillary immunization commodities from the
Central Cold Storage Facility and Warehouse to the identified recipients shall be based on
the allocation list provided by the Task Group on Program Implementation. A separate
guideline shall be issued this effect.
to

For Strict Compliance.

By Authority of the Secretary of Health:

—_—
an
MA. CAROLINA/VIDAL-TAINO, CPA, MGM, CESO III
Undersecretary of Health
Procurement and Supply Chain Management Team