Choosing a Qualified Person: Qualification Rules and On-Site Duties

1. Key takeaways

A Qualified Person (QP) is a mandatory position for an LTO, and the qualification required is set by product category in AO No. 2024-0015, Annex C. Establishments handling medicinal products typically need a Registered Pharmacist; on the device track the role may be filled by a person with a background in a relevant engineering, biomedical or allied health discipline. The name and qualifications of the QP must be entered in the eServices application form, and the post carries the technical liaison and compliance assurance duties attached to the licence.

• Not a nominal post: the QP signs the application and answers for technical compliance during inspections and events.
• Category specific: the standard for medicines does not cover devices, and the reverse also applies.
• Registered on the licence: a change of QP is a change to the licensed information, not an internal HR matter.
• Distinct from the MAH: the QP responsibility is attached to the establishment, the MAH responsibility to the product.

2. Legal basis

The qualification requirements sit in an annex to the licensing order rather than in the main text, which is why applicants who read only the body of the order tend to underestimate the evidence needed for the QP file.

3. Expert insights

First insight: the QP is a technical guarantor, not a name on a form. In the Philippine system the QP is the technical liaison between the establishment and the FDA, responsible for assuring that imported or distributed products conform to the safety standards declared at registration. That positioning determines what the role can and cannot be. The QP signs the application documents, appears in the licence record, and is expected to explain technical positions during inspections and in the handling of events. A holder that lists a qualified person who never sees the file is creating a defect that will surface at the first inspection, and possibly earlier if an adverse event requires a technical explanation that nobody in the company can give.

Second insight: device qualifications differ from medicinal product qualifications, and the wrong standard is a common error. The requirements are differentiated by product category. Establishments that handle both medicines and devices need particular care: a QP qualified on the medicinal product standard cannot cover the device business, and a QP qualified on the device standard cannot cover the medicinal product business. GRZAN advises checking Annex C item by item against the product categories actually traded when applying for the LTO, and then staffing to the highest applicable requirement rather than to the most convenient one. Where a company holds a mixed portfolio, this may mean more than one qualified person or a single person whose credentials satisfy both sets of criteria.

Third insight: QP departure is a hidden LTO risk. The QP name is registered in the LTO application information. If the QP leaves and the record is not updated, the establishment sits in a state where a QP exists on paper and nobody performs the function in practice, which is treated as a deficiency at inspection. The workable practice is to manage QP changes through the LTO variation process: a QP change triggers an immediate variation application and an update of the eServices information. Because the vacancy is invisible until someone looks, the internal trigger has to come from human resources rather than from the regulator.

Fourth insight: QP and MAH responsibilities are cumulative, not alternative. AO No. 2025-0030 makes the MAH the entity responsible for vigilance, while the QP is the technical guarantor at establishment level. The two duties have different sources and different levels: the MAH answers for the market conduct of the product, which is an institutional responsibility, while the QP answers for the technical compliance of the establishment, which is a post-based responsibility. Missing either leaves the compliance chain incomplete. A well-run operation therefore documents the boundary between them, so that a complaint arriving at the QP desk is routed to the MAH vigilance function within a defined time rather than being absorbed informally.

4. Practical recommendations

• Check qualifications item by item against Annex C. Staff to the highest requirement among the product categories actually traded.
• Include the QP in the personnel register. Record name, licence number, qualification documents and current employment status.
• File the LTO variation as soon as the QP changes. Avoid a gap between the nominal and the actual position.
• Establish a backup QP. An A and B arrangement on a critical post reduces single-point risk during leave or transition.
• Write the division of duties with the MAH into the agreement. Prevent both overlap and a vacuum in vigilance responsibility.

5. Verification checklist

• □ Qualification basis checked against AO No. 2024-0015, Annex C
• □ Match with product categories verified separately for medicines, devices and mixed operations
• □ Licence or diploma valid, whether a PRC ID or a graduation diploma
• □ Training records available, covering device safety, quality and use
• □ Actual performance of the role confirmed, rather than a nominal appointment
• □ Variation filed promptly when the QP changes
• □ Division of duties with the MAH stated in the agreement

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support across Southeast Asia, including the Philippines. Our team prepares CMDN/CMDR dossiers to ASEAN CSDT structure, manages submissions and deficiency responses with the FDA Philippines, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com