Transcript A.O.56 seminar

FDA shall issue a certification for those FDA
licensed establishments applying for
amendment during the validity of their
Licenses to Operate. This certification shall
form an integral part of the LTO attachment
issued at the time of LTO renewal.
Consequently, all amendments shall be
incorporated once the LTO is re-issued for
renewal. Thus, previous LTO and
certifications related to amendments shall be
surrendered to this Office.
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1. Inclusion or deletion of product (finished
or raw material) and/or product line
2. Inclusion or deletion of sources (including
toll manufacturer/repacker, trader)
3. Change in business name/address of the
source and/or manufacturer.
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4. Change of key personnel for Quality
Assurance, Quality Control, Production
Manager, Authorized Person and Pharmacist
as reflected in the LTO.
5. Inclusion or deletion of activity e.g. from
Manufacturer to Toll Manufacturer/Repacker/
Importer/Exporter or Trader to
Trader/Importer/ Exporter (raw materials or
finished bulk products)
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1. Change of business name, ownership and
transfer of location of the establishment
2. Re-classification of the establishment (e.g.
from Distributor/Importer to
Distributor/Wholesaler), except for those
which were reclassified into another class of
establishment (e.g. from
Distributor/Importer/ Wholesaler to Trader).
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Payment for the amendments shall be
collected in accordance with the existing
regulations pertaining thereto.
No change in the previously approved
circumstances of the application of the
establishment shall be effected unless proper
notification and submissiono f necessary
documents to the FDA and approval of such
change(s) has been made.
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NOTE: Change of address for drug
manufacturer is considered opening, hence
all the documentary requirements for initial
application shall be submitted and payment
of the initial license fee shall be made.
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Change of Business Name:
1.Official Letter regarding the change of business
name.
2.Notarized Accomplished Petition Form
Note: Notarized Certificate authorizing the
person who signed behalf of the
establishment/company, if he/she is not the
owner or one of the incorporators as registered
with DTI/SEC.
3. Joint affidavit of undertaking/Information
Sheet(drugs and cosmetics only).
4.Photocopy of Business Name(DTI/SEC/Business
Permit).
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5.ID picture(5cm X 5cm) of the
owner/authorized representative and
pharmacist(drugs and cosmetics only).
6.Photocopy of Contract /Agreement with
Manufacturer reflecting new business
name(Trader/Repacker/Distributor).
7. Surrender original LTO.
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Change of Business Address:
A. For Manufacturer/Repacker –All the genera
and additional requirements for the opening.
B. For Trader(Drug and Cosmetics Only)
1.Official letter regarding the change of
business address
2. Photocopy of Business Name Registration
(DTI/SEC/Business Permit)
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3.Notarized Valid Contract of lease or TCT.
4.Floor plan and location plan of the office/
storage areas.
5. Photocopy of Contract/Agreement with
the Manufacturer reflecting the new address.
6. Surrender original License to Operate.
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Change of Ownership
1.Official Letter regarding the change of
ownership.
2.Notarized Accomplished Petition Form
Note: Notarized Certificate authorizing the
person who signed behalf of the
establishment/company, if he/she is not the
owner or one of the incorporators as registered
with DTI/SEC.
3. Joint affidavit of undertaking/Information
Sheet(drugs and cosmetics only).
4.Photocopy of Business Name(DTI/SEC/Business
Permit).
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5.ID picture(5cm X 5cm) of the
owner/authorized representative and
pharmacist(drugs and cosmetics only).
6.Photocopy of Contract /Agreement with
Manufacturer reflecting new business
name(Trader/Repacker/Distributor).
7. Photocopy of Deed of sale/Transfer of Rights.
8. Photocopy of Contract of Lease/TCT.
9. Photocopy of Dissolution Papers from
SEC(Corporation/Partnership)
10.Photocopy of Financial statement duly
notarized and received by the BIR.
11. Surrender original LTO.
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Change of Pharmacist:
1.Accomplished Notice/Affidavit for Change of
Pharmacist duly notarized.
2. ID picture of the owner/authorized
representative and Pharmacist (size 5cm x 5cm.)
3.Photocopy of Pharmacist’s Registration Board
Certificate, PRC ID,PTR.
4. Photocopy of FDA Licensing Seminar
5. Duties and Responsibilities of the Pharmacist
6.Photocopy of the resignation letter from the
previous company.
7.Pharmacist clearance.
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A. Filing of Applications
An application, whether initial, renewal,
automatic renewal or amendment, is deemed
filed upon submission of duly accomplished
application form and Self-Assessment
Checklist (SAC) with the complete attached
required documents, payment of required
fees and acceptance of the authorized FDA
officer. Failure to comply with the
requirements within the prescribed period
shall mean denial of the application.
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Any application not pursued by the applicant
within three (3) months from filing shall be
deemed discarded and will be automatically
cancelled and delisted from the application
list.
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An application shall be filed with the
respective Regional Field Offices having
jurisdiction over the establishment or as
defined in accordance with issuance.
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Initial application. It shall be filed prior to
operation subject to compliance of the
requirements and conduct of site inspection
but in no case shall the establishment
commence to operate until the issuance of
the corresponding License to Operate.
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Renewal application.
Regular renewal shall be filed six (6) months
prior to expiration of the original validity of
the LTO.
Automatic renewal shall be filed prior to the
expiration of the original validity of the LTO.
A. Place of Business, Warehouse or Plant
 All the office, warehouse and plant shall be covered
by a single license notwithstanding their distance or
different locations within one locality indicating
merely their address in the license, except when any
of the office, warehouse and plant carries an entirely
different and complete stage of operation for
different product, in which case, each shall be
covered by separate license. In this instance, the
principal office address shall be reflected at the front
page of the LTO while the others at the back page
thereof or secondary page appended thereto.
 The place of business should be situated in
accordance with the zonal site.
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Every licensed establishment shall cause the
public display the duly issued license in a
conspicuous place within the premises of the
establishment.
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Any request for information whether by the
company or any other party shall be governed
by the existing policies on disclosure.
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A. Validity
All Licenses to Operate shall have the following
validity for any classification of drug
establishments from the date of issuance
reflected as such and renewal thereafter.
a. Initial – Initial LTO issued shall be valid for one
year
b. Renewal- Renewed LTO shall be valid for two
years
In either case, the LTO shall be valid only in the
address indicated therein and the warehouse or
plant covered.
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An LTO shall be re-issued upon the filing of
request with affidavit of loss or affidavit of
such destruction and other documents
whenever necessary and payment of the
prescribed fee. Provided that there is no
change whatsoever in the establishment,
otherwise the same shall be treated as
amendment or initial as the case may be.
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a. Automatic. Any application for renewal of a
LTO filed after one-hundred twenty (120)
days after the expiration of the original
validity shall be automatically considered
expired and cancelled. Likewise, unrenewed
LTO for successive years shall be
automatically cancelled and deleted from the
list of registered establishments.
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b. Voluntary. The owner or authorized person of
a licensed establishment may apply before the
FDA or its regional field office having jurisdiction
over the establishment for voluntary cancellation
of its existing license by filing a formal
notification together with the original LTO
issued, or in case of loss or destruction, an
appropriate affidavit therefore.
Any voluntary cancellation intended to defraud
the government, its creditors, and/or its workers
shall not deprive FDA jurisdiction to perform acts
in ensuring the safety of the public.
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c. Involuntary- This shall be effected only on the
grounds and procedures provided in the Rules of
Administrative Procedure provided in the IRR OF
RA 9711 or other relevant rules and regulations
in case of violation or upon petition by any party.
Nothing in this section shall restrict the FDA or
the DOH in imposing the penalty of suspension,
revocation, or cancellation of LTO or other
authorization for administrative violations of any
other relevant laws or their implementing rules
and regulations.
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Any notice of disapproval of applications for
license or authorization or suspension,
revocation, or cancellation of an existing
license, or authorization must clearly state
the ground/s on which the disapproval,
suspension, revocation, or cancellation is
based.
Thank
You!