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 ANNEX B  
 
QUALIFIED PERSON QUALIFICATIONS AND CREDENTIAL REQUIREMENTS  
 
Type of Establishment  Qualified Person  Qualification/Requirement  
CDRR  
Drug Manufacturer, Trader  
and Distributor (wholesaler, 
importer, exporter), CROs 
and Sponsors, drug outlet, 
and RONPD  
 
Veterinary Drug Retailers 
and Veterinary RONPD  Registered Pharmacists (RA 
10918)  
 
 
 
 
 
Licensed Doctor of Veterinary 
Medicine (RA No. 9268)  a. Professional Regulation  
Commission (PRC) 
Identification Card (ID)  
b. Seminar/training certificate, 
learning and development 
activities on drug safety, 
quality, and efficacy and other 
applicable trainings (e.g., 
Training for Pharmacy 
Assistant, Basic and Advance 
Course on Good Clini cal 
Practice for CROs/ sponsors  
c. Certificate of Completion as 
provided by the FDA  
d. Proof of termination of 
employment if previously 
connected with another 
pharmacy/establishments  
CFRR  
Food Manufacturer, Trader 
and Distributor 
(Wholesaler, Importer, 
Exporter ) 
 Preferably a graduate of food -
related courses including but not 
limited to food technology, food 
and nutrition, chemistry, 
microbiology, chemical/sanitary 
engineering, veterinary medicine, 
fisheries, agriculture (RA 10611).  a. Seminar/training certificate 
on food safety, GMP or 
HACCP given by the 
academe, WHO, FAO, 
NGOs, cooperative, food 
industry organizations, or 
professional organizations  
b. Certificate of Completion as 
provided by the FDA  
 
CDRRHR  
 
 Retailers of ophthalmic 
lenses, prisms, contact 
lenses and their 
accessories and 
solutions, low vision 
aids, and similar 
appliances and devices 
wherein the dispensing is 
governed by RA 8050 or 
the “Revised Optometry 
Law of 1995”  
 Optometrist  
 PRC ID  
 
 Manufacturer, Trader, 
and Distributor 
(Wholesaler, Importer, Graduate of engineering courses 
preferably chemical, sanitary, civil, 
and mechanical, or other science PRC ID for professions with 
Board/Licensure examination or 
Diploma for profession without Page 2 of 4 
 Exporter) of health -
related devices 
specifically:  
- Equipment or 
devices used for 
treating sharps, 
pathological and 
infectious 
wastes  
- Water 
purification 
treatment 
devices and/or 
systems  courses relevant to the device to be 
distributed  Board/Licensur e examination. 
For water treatment devices, a 
copy of diploma shall be 
provided.  
 Manufacturer, Trader, 
and Distributor 
(Wholesaler, Importer, 
Exporter) and Retailer 
of medical devices  a. Registered professional or 
graduates in the field of health 
profession such as Pharmacy, 
Nursing, Medical Technology, 
Dentistry, Radiologic 
Technology, Medicine, Physical 
Therapy, and other allied 
science courses relevant to the 
device to be distributed  
b. Engineering profession that 
includes but not limited to EE, 
ECE, ME, CoE,  CHE, SE, 
Computer Science, and 
Chemistry  a. Certificate of Attendance to   
seminars, training, learning and 
development activities on device 
safety, quality and use given by 
the academe, industry, 
organization, professional 
organization, National 
Regulato ry Authorities, 
international organization which 
includes the WHO and ISO.  
 
b. PRC ID for professions with 
Board/Licensure exam or 
Diploma for profession without 
Board/Licensure exam  
 
CCHUHSRR  
 
 Manufacturer of 
Cosmetic establishments   
 
Registered Chemist,  Chemical 
Engineer, or Pharmacist   
 
Valid PRC 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 Regulato ry Page 3 of 4 
 Authorities, international 
organizations  
 Manufacturer, trader, 
and distributor 
(wholesaler, importer, 
exporter) 
Household/Urban 
Hazardous Substances  For HUHS  - Registered 
professional or graduates in the 
field of allied health, chemistry, or 
chemical e ngineering with 
verifiable, recognized, and updated 
trainings on the safety, quality, and 
use of HUHS  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 
HUHS safety, quality, and 
use, given by the academe, 
industry organization, 
professional organization, 
National Regulatory 
Authorities, international 
organizat ions 
For HUP  - Registered professional 
or graduates of Pharmacy, 
Chemistry, Chemical Engineering, 
Toxicology, Veterinary Medicine, 
Agricultural Biotechnology 
(Entomology) and Entomology  a. Valid PRC ID for professions 
with board/licensure exam or 
Diploma fo r 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 
HUP safety, quality, and use, 
given by the academe, 
industry organization, 
professional organization, 
National Regulatory 
Authorities, international 
organizations.  
For TCCA  - Bachelor’s degree 
with verifiable, recognized, and 
updated trainings on the safety, 
quality, and use of TCCA  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 
TCCA, safety, quality, and 
use, given by t he academe, 
industry organization, 
professional organization, Page 4 of 4 
 National Regulatory 
Authorities, international 
organizations  
 
When applicable,   
the following information may be requested by the FDA in the Application Form  
Drug Manufacturer  a. Production Manager/head  
b. Quality Assurance Manager/head  
c. Quality Control Manager/head  
d. Authorized person for batch release  
e. Pharmacovigilance officer  
Food Manufacturer  a. Production Manager/head  
b. Quality Assurance Manager/head  
c. Quality Control Manager/head  
d. Food Safety Officer  
e. Any designated senior technical personnel  
Medical Device Manufacturer  
 a. Production Manager/head  
b. Quality Assurance Manager/head  
c. Quality Control Manager/head  
Cosmetic and HUHS Manufacturer  
 a. Production Manager/head  
b. Quality Control and/or Assurance 
Manager/head  
c. Product Safety Assessor