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Republic of the Philippines

Department of Health
BUREAU OF QUARANTINE
25th and A.C. Delgado Streets
Port Area, Manila
109 'YeaIJ cf
'Ensuri1lfJ J{eartli Security
at <1b1Uof'Elltty

24 March 2011

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MEMORA:NDUM CIRCULAR
No. 2011 ~ -A02....)__

SUBJECT:

"Guidelines for the Processing and Implementation of Fees and


Charges for the Shipment of Biological Specimen Intended for Use
in Clinical Research"

I. RATIONALE:
The Philippine Clinical Research Professional Inc. (PCRP) an association of clinical
research professionals from the academe, pharmaceuncal industry, contract research
organizations (CRO) and other groups involved in clinical research made known their
concerns on the processing of quarantine permits and. recommended for its timely
issuances thereof, in order to help boost the clinical research industry and provide an '
added incentlve to the influx of clinical studies into the country.
In this regard, the Bureau of Quarantine (BOQ), a health authority mandated to
ensure security against the introduction and spread of infectious diseases at points of
entry reviewed the said proposal. The concerns raised were noted to be considerably
reasonable:and the recommendations likely to be workable, beneficial, and cost-effective
for all parnes without compromising health security.
Given the situation and in accord to minimal interference to travel and trade, the
following g'uidelines thru this administrative order are hereby issued.
II. DElLARATION

OF POLICIES:

'.

Thele operational guidelines shall be guided by the following legal mandates and
policies:
1. Republic Act 9271 " The Quarantine Act of 2004" An act strengthening
the regulatory capacity of the. Department of Health in quarantine and
international health surveillance;
2. Administrative Order No.
Regulations of RA 9271;

Tel. Nos.: 301910] to 17

Fax No.: 527-4678

Email Add:

186 s 2004

info@quarantine.doh.gov.ph

"Implementing

Rules and

URL: http://www.quarantine.doh.gov.ph

3. Administrative Order No. 2006-0010 "Revision of Fees and charges


imposed by the Bureau of Quarantine in accordance with RA 9271.

III.

I GOALS AND OBJECTIVES:

To J>rovideguidelines and procedures in order to ensure efficient and effective


processing bf quarantine permits intended for use in clinical studies or research.

IV.~cope and

Coverage:

'/;.

This order shall cover all contract research organizations, pharmaceutical


companies.: academic institutions and other entities involved in the shipment of biological
specimen intended for clinical studies or research.
I

V. IMPLEMENTING GUIDELINES:
A. All contract research organizations, pharmaceutical companies, academic

B.

C.

D.

E.

F.

G.

institutions and entities involved in the transport of biological specimens


shall first secure a Bureau of Quarantine (BOQ) permit before shipment;
Application form detailing the particulars of the clinical study shall be used
in applying for this permit (Annex A).
Quarantine permit issued for every clinical trial study shall be valid for a
period of one (1) quarter starting from the date of issuance (Annex B);
At the end of every quarter, the concerned clinical research organization,
shall be responsible to declare and report the number of shipments made
covered by the shipment permit to the Bureau of Quarantine (BOQ);
Payment shall be made thereafter based on the number of shipment
incurred during the quarter corresponding to the shipment dates when
biological samples were sent out of the country. Applicant shall use the
Application for Renewal of Export Permit (Annex C);
It is understood that for every quarantine shipment permit issued, this
correspond only to one (1) particular clinical study/protocol;
Shipment handling and packaging shall at all times be in accordance to
International Air Transport Association (lATA), Airlines or other equivalent
regulations.
The Bureau of Quarantine (BOQ) reserves the rights to cancel any issued
permit anytime without prior notice as deemed necessary in the interest of
public health.

VI. ROLES AND RESPONSIBILITIES:


. 1. The Bureau of Quarantine (BOQ) shall implement the order with efficiency
and continue working toward streamlining the process for the benefit of
all concerned and in partnership with the Philippine Clinical Research
Industry.

2. The Philippine Clinical Research Professionals Inc. (PCRP) and other


concerned Contract Research Organizations shall be responsible for
disseminating this Memorandum Circular and ensure honest compliance by
its members, personnel, affiliates and forwarders.

VII.

REPEALING CLAUSE:
,

i All other related issuances inconsistent or contrary to the provisions of this


A.D. are hereby revoked, revised, modified, rescinded and/or repealed, accordingly.
VIII.

EFFECTIVITY:

~.----

This order shall take effect on '01 A ri

EDGARDO C. SABITSANA, MD, MPH


Director IV, CESOIlL.

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