[Updated] Philippines to Modify the Requirements for Licensing and Inspection of Health Products, Cosmetics Included

Editor's Note: This article was originally published on Jun. 10, 2022, and was updated on Oct. 13, 2022, as per the latest developments.

On October 3, 2022, Philippines released the second draft amendment to update the guidelines on licensing and inspection of health products. All concerned stakeholders can submit comments to [email protected] no later than October 14, 2022. ² Compared with the first draft, supplementary requirements are included to further streamline the processes involved in FDA's licensing and inspection work, which are marked in red in the following article.

On May 27, 2022, Philippines Food and Drug Administration (FDA) released a draft of Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017 (the Updated Guidelines) for public comments until June 2, 2022. The Updated Guidelines shall take effect 15 days after its publication in at least two nationwide circulated papers and upon filing at the Office of the National Administrative Register (ONAR) at the UP Law Center, Diliman Quezon City. ¹

The Updated Guidelines is formulated to repeal the Administrative Order (AO) No. 2020-0017, otherwise known as the "Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003". Compared to AO No. 2020-0017, the main revisions proposed by the Updated Guidelines include:

1. Further Clarifying the Qualification for the Qualified Person

Qualified Person (QP) refers to an organic or full-time employee of the establishment who possesses technical competence related to the establishment's activities and health products by virtue of his profession, training or experience. Based on provisions about the QP stated in AO No. 2020-0017, the Updated Guidelines supplements that the QP is not and shall not be connected to, employed by or engaged with any other FDA-regulated establishments. Moreover, a single QP may be allowed to handle a single establishment with multiple FDA-licensed activities, provided that the QP remains to sufficiently carry out his/her duties and responsibilities.

For different types of cosmetic establishments, the qualification for the QP is further clarified in Annex B to the Updated Guidelines as:

2. Supplementing Requirements for LTO Application

In Philippines, all cosmetic companies shall obtain a License to Operate (LTO) prior to engaging in manufacturing, importation, distribution and sale of cosmetics. The LTO is also an essential requirement to be able to notify cosmetic products with the FDA. AO No. 2020-0017 introduced required documents and procedures for applying for LTO. To supplement these provisions, the Updated Guidelines prescribes that, when apply for the initial LTO, in addition to the previously required e-application form and a proof of business name registration, the establishments shall also submit:

• Proof of capitalization for manufacturers and traders (latest audited financial statement with balance sheet or declaration of capitalization);

• Site Master File, Risk Management Plan, and Floor Plan (for manufacturers);

• Self-assessment checklist;

• Certificate of Compliance with technical requirements.

It is worth noting that attendance to trainings and seminars of the FDA Academy shall no longer be a requirement in the application for LTO. Stakeholders may provide proof of training from other institutions offering technical courses relevant to their establishment and activity. Besides, upon the receipt of LTO, the establishments shall print the LTO as a full-colored page on a standard A4 size (21 cm x 29.7 cm) paper and in portrait orientation. It shall be positioned on the most conspicuous place within the business establishments.

3. Devising a More Comprehensive Plan to Regulate Inspection

In terms of inspection, AO No. 2020-0017 only indicated the establishments subject to inspection, and stipulated that all establishments shall not have a virtual office. In contrast, the Updated Guidelines set down more requirements for regulating the pre-licensing and post-licensing inspection. According to the Updated Guidelines,

• All manufacturing and non-manufacturing establishments shall be subject to Post-Marketing Surveillance (PMS) and post-licensing inspections respectively during the period of validity of the LTO. The period for re-inspection shall be determined by the FDA, wherein a Certificate of Compliance following a satisfactory re-inspection shall be required for any coinciding application for the renewal of the LTOs of the establishments.

• All establishments with virtual offices will be accepted, provided that there are physical offices where the licensed activities are conducted. However, the FDA will not recognize the virtual office as the address to be reflected in all the documentary requirements when transacting with the agency.

• The FDA may conduct inspections in collaboration with the local government units and other relevant agencies or offices.

To ensure a smooth transition, the FDA also sets transitional provisions for concerned establishments to comply with the updated requirements. As introduced in the second draft amendment,

a. All existing applications for LTO received before the Updated Guidelines takes effect shall be processed according to the previously approved issuances;

b. All establishments with valid LTO before the Updated Guidelines takes effect shall be given a period of one year to comply with the provisions hereof.