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Initial Application of LTO

FDA LTO initial application form for Drugstore

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH
DRUGSTORE (

) / HOSPITAL PHARMACY (

) / INSTITUTIONAL PHARMACY (

)

SELF-ASSESSMENT TOOLKIT FORM
INITIAL APPLICATION OF LICENSE TO OPERATE

COMPANY NAME
COMPANY ADDRESS
OWNER
ACTIVITY

:
:
:
:

RETAILING
STERILE COMPOUNDING
MOBILE PHARMACY

NON-STERILE OMPOUNDING
ONLINE ORDERING AND DELIVERY

Directions:
Fill out the form by ticking the applicable box. Provide remarks on the client’s column when necessary. Submit in
Portable Document Format (pdf) and word format duly signed by the pharmacist/owner.

DOCUMENTARY REQUIREMENTS:

Yes

No

REMARKS
CLIENT

FDA

1. Application Form
 Is the integrated application form properly filled out?
 Is it duly notarized?
 Are the signatories in the application form the authorized
persons as required under the following circumstances?
(a) If single proprietorship – the owner as registered in DTI
(unless there is a different authorized person)
(b) If partnership/corporation – one of the incorporators or
authorized person as indicated in the board resolution or
Secretary’s Certificate
(c) If cooperative – authorized person indicated in the board
resolution or Secretary’s Certificate of the cooperative
If the signatory is not the owner or one of the incorporators, as
the case may be:

Is there a board resolution or notarized Secretary’s
Certificate clearly identifying the person authorized to sign
for and in behalf of the owner or corporation submitted?
For government-owned establishments:








Is there an Order (or equivalent document) identifying the
person authorized to sign for and in behalf of the
establishment submitted?
2. Proof of Business Name Registration
(a) For single proprietorship, Certificate of Business
Registration issued by the Department of Trade and
Industry (DTI)
Is the business name applied for LTO the same with that of
DTI registration certificate?
Note: If franchisee, the business name of the franchisor shall
be used.
Is the DTI certificate still valid?
Is the owner appearing in the application form the same with
that of the DTI certificate?
Is the address of the establishment applying for LTO within
the territorial coverage? If the business address indicated in

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DTI is different from the exact address as declared in the
application form, is there a clear copy of Business/Mayor’s
Permit or Barangay clearance indicating the complete
address of drug establishment?
(b) For corporation, partnership and other juridical person,
Certificate of Registration issued by the Securities and
Exchange Commission (SEC) and Articles of
Incorporation
Is the business name applied for LTO the same with that of
the SEC registration certificate? If the company uses another
business name style different from its corporate name, is an
amended SEC registration reflecting the same submitted?
Is the address indicated in the SEC the same with the address
of the establishment applied for LTO?
o If the address in SEC is still occupied but the
business operation applied for LTO is located
in a separate area, is a clear scanned copy of
Business /Mayor’s Permit or Barangay
clearance indicating the complete address of
drug establishment submitted?
o If the address in SEC is no longer occupied, is
an amended SEC registration reflecting the
current business address submitted?
Is the type of activity and product applied for LTO indicated
in the Articles of Incorporation (Article II)?
(c) For cooperative, Certificate of Registration issued by the
Cooperative Development Authority and the approved
by-laws
Is the business name applied for LTO the same with that of
the CDA registration certificate?
Is the address indicated in the CDA the same with the address
of the establishment applied for LTO?
Is the type of activity and product applied for LTO indicated
in the approved articles and by-laws of the cooperative?

(d) For government-owned or controlled corporation
 Is there a copy of the law creating the same? (if with original
charter)
Note: If the drugstore is not owned by the government, certificate
of business name registration shall follow the requirements
under 2.a,b,c (where applicable).
3. Credentials of Pharmacist and Responsible Pharmacy Assistant
 Is the responsible pharmacist identified?
Identify the name under client’s remarks:
 Is the PRC ID of the responsible pharmacist still valid?
 If the PRC is not valid, is there a proof of renewal attached?
 Is the resignation letter of the responsible pharmacist from
previous company signed/ conformed by the owner/authorized
representative of the establishment? (where applicable)
 Is the LTO number of the previous company indicated?
 Is the name of pharmacist in the certificate of attendance to
FDA seminar on licensing of establishment the same with
application form for LTO?
 Is the seminar attended corresponds to the type of LTO
applied by the establishment?
 If not yet attended, is any proof of confirmation issued by the
FDA Academy of the scheduled licensing seminar included?
 Is the pharmacy assistant/s identified?

2

Identify the name under client’s remarks:
 If a pharmacy assistant is employed, is a copy of Pharmacy
Services National Certification (NC) III issued by TESDA
submitted?
 If there is no (NC) III certificate provided, is there a
certificate of attendance to the PA Summit or proof of
registration of the summit submitted?
4. Risk Management Plan
Are the risks for the establishment properly identified?
Are there plans of action for these identified risks?
Is there an established SOP for pharmacovigilance?
Is there an established SOP for handling regulatory mandates
from FDA, such as product recall, withdrawal, suspension of
activities, etc?
Note: While the official RMP framework from FDA is not yet
issued, a commitment letter must be submitted.





5. Location Plan
 Is the sketch submitted indicates certain landmark?
 Is the Global Positioning System (GPS) Coordinates
included?
6. Picture of Drugstore with Display of Signage
 Does the picture clearly show the signage bearing the exact
business name of the establishment as registered in DTI/SEC
(except for franchise drugstore)
 If the signage does not bear the exact business name of the
establishment as registered in DTI/SEC, is there a
certificate/document from the Intellectual Property Office
(IPO) submitted?
7. Proof of Payment
 Is the payment made according to the required fee?
 Is there a scanned copy of proof of payment (e.g FDA official
receipt, Landbank On-coll validated slip ) submitted?
NOTE: ADDITIONAL DOCUMENTS MAY BE REQUIRED TO BE SUBMITTED AS DEEMED NECESSARY.

ADDITIONAL REQUIREMENTS
(ON-SITE INSPECTION ONLY):
1.

Agreement between the franchisor and franchisee, where applicable

2. Records/E-file
(a) Records of invoices containing the minimum required data such as but not limited to: name of product, complete name
& address of drug supplier, packaging size, dosage form & strength, batch/lot number, expiry date, date and quantity
received by the establishment.
(b) Prescription book or e-file to be kept for 2 years
(c) Senior citizens, PWD
(d) Menu cards (generics, MDRP, GMAP)
(e) Information, Education and Campaign (IEC) Material
3. Standard Operating Procedure
(a) Receipt and Dispatch
 Is there an orderly and secure system of filling up to date invoices from suppliers and buyers identifying lot numbers
or batch numbers of manufacturers stock pursuant to FDA Memo Circular No. 001 s. 1983? Is there a product description,
expiry date and transport temperature?
(b) Handling of consumer complaints, product recalls, and other regulatory mandates
 Does the establishment maintain registry of complaint with action?
(c) Disposal of expired/deteriorated/ damaged and returned products
(d) Cleaning of Storage Area

3

 Is there a regular conduct of pest control?
(e) Other SOPs as required
4.
5.

Display of Information, Education, and Communication Materials as required
If with additional activity:
(a) Certificate of Training of the Pharmacist
(b) Documents related to the additional activity with proof of validation

6. Reference Materials
(a) R.A. 3720, R.A 9711, R.A. 6675, R.A. 5921, R.A. 8203, R.A. 9502
(b) WHO Annex 5 Guide to Good Distribution Practices (GDP) for Pharmaceutical Products and Annex 9 Guide to Good
Storage Practices for Pharmaceuticals
(c) Philippine National Drug Formulary
(d) Standard Practice Guidelines (Phil. PSP)
(e) Pharmacovigilance-related References
(f) Other applicable reference materials, including latest issuance of FDA related to community practice
--- To be filled out by client: --Prepared by:
Signature:
Position (Pharmacist / Owner):
Date:
--- To be filled out by RFO: --Decision:
Remarks:
Approval
Denial
Clarification
Inspection
Evaluated by:
Date:

--- To be filled out by CDRR: --Decision:
Approval
Clarification
Evaluated by:

Remarks:

Date:

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