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REPUBLIC OF THE PHILIPPINES DEPARTMENT OF HEALTH BUREAU OF FOOD AND

DRUGS
Civic Drive, Filinvest Corporate City Alabang. Muntinlupa City
Tel. No.: 007-0721 Website www.blad gov ph

BUREAU CIRCULAR No. 011 s. 2006


TO: ALL CONCERNED
SUBJECT: Specific Operational Instructions Implementing Administrative Order No.
2005-0031 dated December 7, 2005, Subiect: Guidelines and Procedure for the issuance of
the Principal Certificate of Product Registration and the Listing of Identical Drug Products
based on the Identity of Manufacturer and Pharmaceutical Formulation

I. Rationale
The issuance of the subject Administrative Order (AO) created the need to clearly define
activities that must be undertaken and the identification of key personnel who shall be
responsible and accountable for the implementation of the consequent activities in issuing
principal Certificate of Product Registration (CPR).
The subject Administrative Order which strategic outcome redounds to shortening of the
review period for technical documents of applicants for Identical Drug Products require the
creation of systems and procedure that would track the status of their validity life of the
Certificate of Listing of Identical Drug Product (CLIDP) with reference to their respective
principal Certificate of Product Registration. Such also necessitates the need to establish a
separate database system and coding system.

II. Objectives
Given the premises so stated above, this circular is issued in order to:
1) To define supplementary specific systems and procedure that would support the
implementation of the reference Administrative Order;
2) To define the roles and responsibilities of key personnel/post who would implement.

III. Scope
This Circular shall cover all applications for principal CPR reckoned from the date of its
approval. Applications for principal CPR subr prior to the issuance of this Circular shall
nonetheless be facilitated for processing subject to review for compliance to the requirements
sought for under AO No 2005-0031 and other applicable issuances.
IV. Specific Instructions
1) Submission of Application
i. Applications for principal CPR and CLIDP shall be submitted every Tuesdays
and Wednesdays to the PAICS office;

ii. The usual procedure for submission shall be undertaken (Maximum of 10


applications per company per day of submission);

iii. PAICS shall accordingly give advice to applicants that should there be no
deficiencies in their submission for their application request for principal CPR or
CLIDP whichever is sought, shall be processed and released within a maximum
of five (5) working days.

2) Requirements for Application of principal CPR


i. Initial Application
1. Documentary Requirements (Forms to be accomplished correctly and
completely)
a. Assessment Slip (Annex "A")
(As revised, Ref: Annex A of BC No. 20 s. 2005 Subject: Revised
Assessment Slips)
b. Notarized Application Form (Annex "B")
c. PART 1 ONLY of the BFAD PSDD Form (Annex "C")
2. Attachments
a. Photocopies of the respective current and valid License to
Operates (LTOS) of the:
i. Principal CPR applicant ii. Toll Manufacturer (if
applicable)
b. Original copy of Certificate Registration of Product
ii. Renewal Application
1. In accordance with the requirement prescribed in AO No. 2005-0031
and AO No. 2005-0030
3) Requirements for application of CLIDP
i. Initial Application
1. Documentary Requirements (Forms to be accomplished correctly and
completely)
a. Revised Assessment Slip (Annex "A")
(As revised, Ref: Annex A of BC No. 20 s. 2005 Subject: Revised
Assessment Slips)
b. Notarized Application Form (Annex "B")
c. PART 1 ONLY of the BFAD PSDD Form (Annex "C")
2. Attachments
a. Photocopies of the respective current and valid License to
Operates (LTOS) of the:
i. Identical Drug Applicant, and
ii. Principal CPR owner/holder
b. Photocopy of the current and valid principal CPR
c. Authenticated copy of the duly notarized Distributorship
Agreement License Agreement, or other written contract between
the principal CPR holder and the Identical Drug Applicant.
d. Facsimile of prepared labeling materials
ii. Renewal of Application
1. In accordance with the requirements prescribed in AO 2005-0030 and
AO 2005-0031
4) Payment
i. Payment shall be based on the remaining CPR validity and registration fee
ii. Fee structure is per AO 50 s. 2001

Branded Unbranded

Initial 3000/year 2000/year

Renewal 2000/year 1500/year

iii. Plus 500 per proposed brand for initial CLIDP applicants only)

5) Coding System of the Principal CPR and CLIDP


i. Each principal CPR shall be uniquely and serially coded with an alphanumeric
system that shall be issued and logged separately from other existing forms of
CPRs; and
ii. Each CLIDP shall be serially uniquely and serially coded with an alphanumeric
system that is hinged to the serial alphanumeric code of its principal CPR as
described in AO 2005-0031.
ii. A database system shall be maintained to track the validity status of the
principal CPR and CLIDP.
iv. The issuance of the unique and serial alphanumeric codes and the attendant
database requirement for principal CPR and CLIDP shall be maintained by the
Product Services Division (PSD).
6) Document Transmission Benchmarks
i. All application for principal CPR and CLIDP shall be transmitted by PAICS to
specifically assigned evaluators within twenty four (24) hours from the receipt of
the application.
ii. Upon receipt of the application documents from PAICS, the PSD shall conduct
the review of said documents and shall prepare the necessary output document
(principal CPR, CLIDP or Notice of Deficiency, whichever is the case) within
twenty four (24) hours. The output document shall be duly initialed by the
evaluator the Chief, PSD and signed by Director IV, BFAD within the same
period.
iii. Once the output document is signed it shall be transmitted to the Policy.
Planning and Advocacy Division (PPAD) which shall make the necessary
database updating and postings to the BFAD website identifying the output
document for release. Thereafter, PPAD shall transmit the subject output
document to the Records Section for scanning and Releasing Section for
immediate release to the principal CPR or CLIDP applicant within twenty four
(24) hours reckoned from the receipt of the duly signed output document.
V. Repealing Clause
Provisions on previous circulars inconsistent with this issuance are hereby modified
VI. Effectivity
This Circular shall be effective immediately.

PROF. LETICIA BARBARA B. GUTIERREZ, MS


Director