retailer - food and drug administration

RETAILER

means any establishment which sells or offers to sell any health product directly to the general public.

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 retail process

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

To ensure that the products are sold and advertised to the appropriate population

COVERAGE

1. Activity 2. Location and Premise 3. Personnel 4. Quality System and Documentation 5. Products 6. Application Process

ACTIVITY

Retail Outlet Over-the-counter sale

Online Selling Internet sale

LOCATION AND PREMISE

Location

Must be outside 100 meters of schools public playground, youth hostels and recreational facilities for minors, including those frequented by minors.

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.


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


Premise

Separate secured area for returned, damaged, rejected, recalled, and expired products

Good storage conditions and adequate lighting


Premise

ENDS/ENNDS products offered must have the necessary authorizations

Must not conduct other activities other than the activity applied for


Advertising

Advertising shall be allowed on the point of sale.

However, advertising activities must not target and must not be directed at minors, non-smokers and non-ENDS/ENNDS users.

Detailed guidelines will be issued by the FDA.

PERSONNEL

Adequate organizational structure

Training and qualifications on good storage and retail practice, regulations, procedures, and safety

Duties and responsibilities defined in the job description

Attendance to appropriate FDA seminars by Qualified Personnel

Hygiene and sanitation training

QUALIFIED PERSONNEL

Can also be the Authorized Person (Owner)

Can handle up to 15 retail outlets with the two farthest outlets not more that 25 km away from each other

Must at least allot 2 hours a week in each outlet

Ensures that all outlets managed 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

Retail Outlet 2 Retail Outlet 1 Retail Outlet 3

Shop Personnel Shop Personnel

Qualified Person

Shop Personnel

Admin, Finance, Logistics

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 Sale 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

Sales and 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 Retailers

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 5,000.00 + 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

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

LICENSING PROCEDURE

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

retailer - food and drug administration

Documents