DISTRIBUTOR/IMPORTER/EXPORTER
means any establishment that imports or exports
raw materials, active ingredients and/or finished
products for its own use or for wholesale
distribution to other establishments or outlets. If
the distributor/importer/exporter sells to the
general public, it shall be considered a retailer.
DISTRIBUTOR/WHOLESALER
means any establishment that procures raw
materials, active ingredients and/or finished
products from local establishments for local
distribution on wholesale basis.
OBJECTIVES
To ensure that all concerned stakeholders understand the process for the
application of a license to operate and the regulatory requirements during
operations
To ensure the quality and identity of products during all aspects of the
distribution process
To set out appropriate steps to assist in fulfilling the responsibilities involved in
the difference aspects of the distribution process within the supply chain
To avoid the introduction of counterfeits into the marketplace via the
distribution chain
To ensure traceability and accountability of all products within the supply chain
COVERAGE
1. Activity
2. Location and Premise
3. Personnel
4. Quality System and Documentation
5. Products
6. Application Process
ACTIVITY
Importer of Finished Products
Foreign sources
Wholesaler and/or Exporter of Finished Products
Local Sources
LOCATION AND PREMISE
Location
Actual address must be consistent with the declared address
in the application
Location of the establishment (whether in a commercial or
residential area) must be indicated
Location must allow the entry of FDA and other government
personnel for the conduct of inspection and monitoring.
LOCATION AND PREMISE
Premise
Business name registration must be
consistent with signboard in front of the
place of business bearing its name
Sufficient storage area for commercial,
rejected, returned or recalled products
LOCATION AND PREMISE
Premise
Separate secured area for returned, damaged,
rejected, recalled, and expired products
Good storage conditions and adequate lighting
LOCATION AND PREMISE
Premise
ENDS/ENNDS products offered must have
necessary authorizations
Must not conduct other activities other than the
activity applied for
LOCATION AND PREMISE
Advertising
Advertising to the general public is not allowed.
However, advertising materials can be provided
to retailers for placement in retail shops.
Detailed guidelines will be issued by the FDA.
PERSONNEL
Adequate organizational structure
Training and qualifications on good storage and
distribution practice, regulations, procedures, and safety
Duties and responsibilities defined in the job description
Attendance to appropriate FDA seminars by Qualified
Person
Hygiene and sanitation training
QUALIFIED PERSONNEL
Can also be the Authorized Person (Owner)
Ensures that the company and all products
distributed are following FDA regulations
Serves as point person during FDA inspections
PERSONNEL
General Requirements:
1. Organizational chart showing the hierarchy of responsibilities
General Manager / President
Regulatory Compliance
Admin and Sales Warehousing
Department
Admin Sales Qualified Person Warehouse Personnel
QUALITY SYSTEM AND DOCUMENTATION
SOPs
Written procedures of all key activities:
Hiring and Training of Key Personnel
Ordering and Receiving of Goods
Storage and Monitoring of Inventories
Handling of Expired, Returned, Reject, Damaged, and Recalled Products
Distribution of Finished Products
Records Keeping
Handling of Complaints
Product Recall
QUALITY SYSTEM AND DOCUMENTATION
Records
Comprehensive records on all receipts and issues of products
Orderly and secure system of invoices from suppliers
Delivery records
Periodic stock reconciliation
PRODUCTS
Product Compliance
Compliant to the technical and labeling
requirements
FDA-registered
With BIR-issued tax stamps
LICENSING PROCEDURE
1. Request for a user account by going to this link and accomplishing the online form:
• https://eportal2.fda.gov.ph/syseportal/en/neoclassic/2025723735d4504e361dde4030330943/2656580155d4641ea8aa1d
9091841768.php
LICENSING PROCEDURE
Authorization Letter
or
Proof of Ownership
LICENSING PROCEDURE
Requirements
Accomplished online application form for Distributors
Proof of Business Name Registration
Business Permit/Barangay Permit
FDA QPIRA (Qualified Personnel in Regulatory Affairs) Certificate for
ENDS/ENNDS
Government Issued ID of authorized person and qualified personnel
Payment (PhP 10,000.00 + LRF)
Note: A notarized commitment letter shall be submitted in lieu of the QPIRA Certificate
LICENSING PROCEDURE
2. Log-in to E-portal Account at https://eportal2.fda.gov.ph
LICENSING PROCEDURE
3. In the HOME tab, select
New Application in the
navigation pane and click
e-License to Operate
(Initial Application) to
proceed to the LTO
application form.
LICENSING PROCEDURE
4. Read and understand the Declaration of Undertaking before selecting “Yes, I agree”
Declaration of Undertaking
I, duly authorized officer/s or representative/s of the Establishment hereby voluntarily and categorically declare, undertake, and
agree that all data and information contained and provided in the attached application, together with all other submissions,
including amendments, are true and correct based on my knowledge and are based on existing records, legal documents and
available information.
I, likewise declares, undertakes and agree that:
•I. The said establishment shall be open during its business hours under the supervision of a PRC registered professional (e.g.
Pharmacists), designated qualified personnel or authorized personnel at all times;
•II. The pharmacist/s and the other appropriate allied health professionals, upon and during employment in the establishment, is/are
not and will not in any way be connected to, employed by or engaged with any other FDA-regulated establishment;
•III. The approved and valid License to Operate shall be displayed in a conspicuous place in the establishment visible to my
customers;
•IV. The establishment will change its business name, and/or brand name in the case of products, in the event that there is a similar,
same, or confusingly similar name registered with the Food and Drug Administration, or if the FDA rules later that such name is
misleading, offensive, against the law, customs, public morals, public policy or otherwise violative of relevant rules and
regulations;
LICENSING PROCEDURE
•V. The electronic copy of the files, documents, or information submitted in relation to this application are the exact duplicate
or scanned copy of the same and, any discrepancy, prejudicial contents, false claims or misrepresentation on any of the data
therein shall be a ground for the disapproval of application, or if discovered post-approval shall be a ground for the
appropriate sanctions including the revocation of the license or, and/or the filing of the appropriate legal action against me,
the owner, its officers or the establishment whenever possible;
•VI. If applying for automatic renewal, the establishment has filed the application, and have paid the complete & appropriate
renewal fee before expiry date and in which case there are no changes or variations in the establishment since last renewal of
LTO specifically but not limited to a change of location, change of ownership, change of business name, change of qualified
person, change in warehouse site, additional supplier and product lines, change in activity, change in key personnel;
•VII. The products that my establishment manufacture, distribute and/or sell are registered or to be registered with FDA prior
to distribution or sale, and that we assume primary responsibility and/or stewardship over the product in case of liability,
adverse events, and/or other public health & safety issues;
•VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized
representatives at any reasonable time and the establishment and its personnel and officers undertake to respond and
cooperate fully with the FDA as regards any subsequent post-marketing activity;
LICENSING PROCEDURE
•IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in business address,
business name, ownership, or any other circumstances in relation to the approval of this application is a ground for the
revocation of the License to Operate;
•X. The above declarations and undertakings which are based on existing regulations are deemed conditions for the approval
of the LTO and therefore non-compliance or defiance after approval can be a cause for SUSPENSION, CANCELLATION,
REVOCATION of the License to Operate which shall be guided by the provisions of Republic Act 3720 as amended by
Republic Act 9711 and other relevant laws, rules and regulations;
•XI. This document is executed in full knowledge and awareness of Republic Act 3720, as amended by Republic Act 9711,
otherwise known as the Food and Drug Administration Act of 2009, other relevant laws and their implementing rules and
regulations; and
•XII. I and the establishment herein represented grants authority to the Food and Drug administration to verify through
government and private resources the veracity of the information provided in all submissions and the authenticity of all the
documents attached or submitted.
LICENSING PROCEDURE
5. Fill up online application form
LICENSING PROCEDURE
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6. Upload Documentary Requirements
LICENSING PROCEDURE
7. Check and Double Check Application
LICENSING PROCEDURE
7. Download and print Order of Payment then click next until the end of the form
LICENSING PROCEDURE
8. Finish submission of application
LICENSING PROCEDURE
9. Pay Fee
