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

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등록일 2022-06-13

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On May 27, 2022, Philippines FDA issued a draft of Updated Guidelines on licensing and inspection of health products. Compared to its predecessor, AO No. 2020-0017, the Updated Guidelines further clarifies the qualification for the qualified person, supplements requirements for LTO application, and devises a more comprehensive plan to regulate inspection.

 

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

Type of Establishment

Qualified Person

Qualification / Requirement

Manufacturer of cosmetic establishments

Registered Chemist, Chemical Engineer, or Pharmacist

Valid Professional Regulation Commission (PRC) Identification Card (ID)

Trader and Distributor (wholesaler, importer, exporter) of cosmetic establishments

Registered professional or graduates in the field of allied health, chemistry, chemical engineering, or cosmetic science with verifiable, recognized, and updated trainings on the safety, quality, and use of cosmetics

a. Valid PRC ID for professions with board/licensure exam or Diploma for professions without board/licensure exam; and

b. Certificate and copy of

program of activities as proof of attendance to seminars, trainings, learning and development activities on cosmetic safety, quality, and use, given by the academe, industry organization,

professional organization, National Regulatory Authorities, international organizations


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).

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.

 

Reference Links

[1] Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017

 

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