Clarifying Mandatory Requirements for FDA Registration in the Philippines

The Requirement of Employing a Pharmacist in Applying for FDA Registration in the Philippines NIcolas and De Vega Law Offices Image

Do you need to employ a pharmacist, even if your company is selling cosmetic products or medical devices, as a requirement for registration with the Food and Drug Administration (FDA) of the Philippines, or in applying for an LTO with the FDA?

To answer this question, we need to understand the legal requirements governing registration with the FDA, particularly in securing a License to Operate (LTO).

It is quite understandable if the application for registration with the FDA pertains to a drug or a pharmaceutical product. The presence of a pharmacist is obviously essential for the company’s operations. However, the requirement seems far-fetched if the applicant for registration is applying for an LTO, in relation to a cosmetic product, a medical device or even a food product.

The Old Rule: A full-time Pharmacist was Mandatory for Businesses and Establishments

Previously, a permanent and full-time pharmacist was necessary in order for a company to secure an LTO. Thus, even a cosmetic company must have a full-time pharmacist under its employment. This finds basis under Section 23 of Republic Act No. 5921, otherwise known as An Act Regulating the Practice of Pharmacy, which defines the practice of pharmacy as follows:

 “Section 23. Definition of practice of pharmacy. A person shall be deemed to be practicing pharmacy within the meaning of this Article, who shall, for fee, salary, percentage or other reward paid or given directly to himself or indirectly through another, prepare or manufacture, analyze, assay, preserve, store, distribute or sell any medicine, drug, chemicals, cosmetics, pharmaceuticals, devices or contrivances used in pursuance thereof; or render pharmaceutical service in any office or drug and cosmetic establishment where scientific, technological or professional knowledge of Pharmacy is applied; or engage in teaching scientific, technological or professional pharmacy subject in a college of pharmacy; or conduct or undertake scientific pharmaceutical research for biological and bacteriological testing and examinations. …”

As can be gleaned from the provisions of Republic Act No. 5921, the practice of pharmacy includes dealing with cosmetic products. Consequently, the FDA mandates almost the same requirements for cosmetic and drug companies, which includes, among others, the presence of a duly licensed pharmacist who has attended an FDA accredited seminar on licensing.

Previously, the pharmacist played a vital role in the company’s applications with the FDA. It must be emphasized that it is the pharmacist who signs the Petition for Application of an LTO with the FDA. Furthermore, the pharmacist also signs the Joint Affidavit of Undertaking to be filed with the FDA. These requirements were mandatory with the FDA.

The pharmacist, previously required by the FDA, must be engaged to render services full-time to the company, or briefly, a full-time employee. since the FDA requires that the operations of the company be under the immediate and personal supervision of the said pharmacist during business hours of the company. Such obligation is also spelled out in the Petition and Joint Affidavit to be submitted with the FDA.

This requirement is even found in Administrative Order No. 56, series of 1989 issued by the Department of Health, which embodies the basic requirements for drug companies, and which have also been made applicable to cosmetic companies.

It must be emphasized that under Administrative Order No. 56, series of 1989, the FDA requires the employment of a Pharmacist, as the said regulation applies to BOTH drug and cosmetics establishments, to wit:

“MEMORANDUM CIRCULAR

No. 15 s. 1990

TO: All drug, devices and cosmetic establishments and all concerned …

‘If a drug establishment engages in activities belonging to more than one of the (classified) categories, applicant must apply for LTO for each of the category and pay the corresponding fees.’

‘Whereas, the general requirements for the issuance of License to Operate include, among others, “a valid Certificate of Registration of the establishment’s Filipino pharmacist issued by the Professional Regulation Commission (PRC)” necessitating the employment of a validly registered pharmacist for each application for a license to operate; …’”

In addition, if the company is to engage in two (2) activities, for example, the distribution of cosmetics, and also the importing of food supplements, two (2) pharmacists may be required by the FDA for the company. This will be necessitated by the fact that the company must apply for an LTO for two (2) activities, namely, as importer and distributor. This is in view of the fact that pursuant to Administrative Order No. 56, series of 1989, an LTO must be applied for each category and one (1) pharmacist must be employed for each classified category.

The New Rule: Pharmacist or Other Qualified Person, and Regulatory Officers are alternatives.

Under Administrative Order No. 2016-0003, the FDA relaxed this requirement for some industries. Consequently, the requirement of hiring a full-time pharmacist is required only for drug companies or drug establishments. With Administrative Order No. 2016-0003, the FDA now refers to a “Qualified Person”.

Thus, for drug establishments, such as pharmaceutical companies, drug stores and establishments dispensing medicine, the FDA still requires the presence of a full-time pharmacist to supervise the operations of the establishment.

However, for cosmetic companies, and other businesses engaged in the sale of medical devices, i.e., medical device establishments, the FDA requires either the presence of a full-time pharmacist or “Other Qualified Professional”. The “Other Qualified Professional” required by the FDA refers to a professional who is licensed by the Professional Regulation Commission (PRC), such as persons who are engaged in the allied science professions of Dentistry, Dental Technology, Medical Technology, Midwifery, Nursing, Nutrition and Dietetics, Optometry, Physical or Occupational Therapy, Psychology, Medicine, and the like. In addition to a PRC-issued ID (which means the Other Qualified Professional is licensed by the PRC), the FDA requires the Other Qualified Professional to attend the Medical Device Qualified Persons in industry Regulatory Affairs (QPIRA) Seminar for medical device establishments, and the Qualified Persons in Industry Regulatory Affairs (QPIRA) Seminar equivalent for cosmetic companies or establishments, conducted by the FDA or its accredited counterparts.

Moreover, for Food Establishments, such as those selling food supplements, the FDA now requires, in lieu of a Pharmacist or Other Qualified Professional, the presence of a full-time Regulatory Officer, who does not need to be either a Pharmacist or a PRC-licensed professional. Of course, the FDA was not remiss when it relaxed the rules. The FDA requires the Regulatory Officer to have attended the appropriate Licensing Seminar, or seminars of Good Manufacturing Processes (GMP), Hazard analysis and critical control points (HACCP), or FDA-conducted/accredited Food Safety Seminars. The FDA even relaxed the requirement further by allowing the submission of a Promissory Letter with a commitment to attend the required seminar, in case the Regulatory Officer or Other Qualified Person under the cosmetic, medical device or food establishment’s employ has not yet attended one.

About Nicolas and De Vega Law Offices

If you need assistance in registration with the Food and Drug Administration, applications for Licenses to Operate, drug, cosmetic, medical device or food registration, assistance in notifications filed under the ASEAN Harmonization Law, or have issues in corporate law, commercial law, corporate or commercial litigation, or civil or other criminal law-related issues,  we can help you. Nicolas and de Vega Law Offices is a full-service law firm in the Philippines.  You may visit us at the 16th Flr., Suite 1607 AIC Burgundy Empire Tower, ADB Ave., Ortigas Center, 1605 Pasig City, Metro Manila, Philippines.  You may also call us at +632 84706126, +632 84706130, +632 84016392 or e-mail us at info@ndvlaw.com. Visit our website https://ndvlaw.com.

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