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Initial Application of LTO

FDA LTO initial application form for drug distributors

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
DRUG IMPORTER (

) / EXPORTER (

) / WHOLESALER (

)

SELF-ASSESSMENT TOOLKIT FORM
INITIAL APPLICATION OF LICENSE TO OPERATE

COMPANY NAME
:
COMPANY ADDRESS
:
OWNER
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 for LTO
Is the application properly filled out?
Is it duly notarized?
Are the signatories in the application form the pharmacist
and 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 the board resolution or Secretary’s Certificate notarized
and clearly identify the person authorized to sign for and in
behalf of the owner or corporation?











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?
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
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

1









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 establishment 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 the pharmacist or other qualified personnel
 Is the responsible pharmacist identified?
Identify the name under client’s remarks
 Is the PRC ID of the pharmacist-in-charge 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 proof of
registration of the scheduled licensing seminar from the FDA
Academy included?
If applying for pharmacist exemption, is the letter indicating
the pharmacist’s duties and responsibilities as well as the
schedule and hours of supervision signed both by the said
pharmacist and the owner/ authorized representative of the
establishment?
Is the Pharmacovigilance officer identified?
Identify the name under client’s remarks
Note: Credentials of the other qualified personnel (e.g. pharmacovigilance officer) will be checked upon inspection.

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?

2

 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 GPS Coordinates included?
6. 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.

Quality Management System

2. Quality Manual and Standard Operating Procedures
(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? Is there a product description, expiry date and transport temperature?
(b) Handling of consumer complaints, recalls, and other regulatory mandates
 Does the company maintain registry of complaint with action?
(c) Disposal of expired/deteriorated/ damaged and returned products
(d) Cleaning of Storage Area
 Is there a regular conduct of pest control?
(e) Other SOPs as required
3. Distributorship Agreement between the Philippine Importer/Exporter and Foreign supplier/importer
(a) For Importer
If the LTO applicant is directly importing products from the manufacturer:
 Is the agreement/certification bears the names of the Philippine Importer and the foreign manufacturer?
 Is there a list of products (listed in generic names with dosage strength, dosage form and brand name,if applicable)
attached to the agreement/certificate?
 Is it valid and duly authenticated by the Territorial Philippine Consulate?
If the LTO applicant is not directly importing from the manufacturer but thru its distributor/exporter/agent:
 Is there an agreement/certification issued by the manufacturer authorizing the distributor/exporter/agent to
distribute/export its products, aside from the agreement between the Philippine importer and the
Distributor/Exporter/Agent? Or a tripartite agreement between the three parties?
 Is it valid and duly authenticated by the Territorial Philippine Consulate?
(b) For wholesaler and/or Exporter
 Is the agreement/certification bears the names of the LTO applicant and its supplier?
 Is there a list of products (listed in generic names with registration numbers and validity, dosage strength, dosage form
and brand name, if applicable) attached to the agreement/certificate?
 Is it valid and duly notarized?
4.

GMP Certificates for foreign manufacturers or equivalent document (where applicable)

5.
(a)
(b)
(c)

Credentials of other qualified personnel (e.g. pharmacovigilance officer)
Curriculum vitae
Updated training records
Other credentials, as required

6.

Proof of Ownership/Lease Agreement of the space/building

7. Reference Materials (Hard copy or e-copy)
(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) Standard Practice Guidelines

3

(d) Other applicable reference materials
--- To be filled out by client: --Prepared by:
Position (Pharmacist / Owner):

Signature:
Date:
--- To be filled out by RFO: ---

Decision:
Approval
Denial
Clarification
Inspection

Remarks:

Decision:
Approval
Clarification
Evaluated by:

Remarks:

Evaluated by:

Date:

--- To be filled out by CDRR: ---

Date:

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