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It is also for this reason that the Implementing Rules and Regulations of Republic Act
No. 9711 include the issuance of authorizations, including Certificates of Product
Registration, as part of its regulatory functions, and not its quasi-judicial functions:
b. Quasi-Judicial Powers, Duties and Functions:
(1) To render decisions on actions or complaints before the FDA pursuant
to the FDA Act of 2009, these Rules and Regulations, other existing laws,
and FDA-promulgated issuances;
(2) To hold in direct or indirect contempt any person who disregards
orders or writs issued by the FDA and impose the appropriate penalties
following the same procedures and penalties provided in the Rules of
Court;
(3) To administer oaths and affirmations and issue subpoena duces tecum
and subpoena ad testificandum requiring the production of such books,
contracts, correspondence, records, statement of accounts and other
documents and/or the attendance and testimony of parties and witnesses
as may be material to any investigation conducted by the FDA;
(a) To obtain information from any officer or office of the national or local
governments, government agencies and its instrumentalities;
(5) To issue orders of seizure, to seize and hold in custody any article or
articles of food, device, cosmetics, household hazardous substances and
health products that are adulterated, counterfeited, misbranded or
unregistered; or any drug, in-vitro diagnostic reagents, biologicals, and
vaccine that is adulterated or misbranded, when introduced into domestic
commerce pending the authorized hearing under the FDA Act of 2009,
these Rules and Regulations, and as far as applicable, other relevant
laws; and
(6) To impose the following administrative sanctions/penalties for
violations of the provisions of the FDA Act of 2009, these Rules and
Regulations, and where applicable, other relevant laws, after observance
of and compliance with due process:
(i) Cancellation of any authorization which may have been granted
by the FDA, or suspension of the validity thereof for such period of
time as he/she may deem reasonable, which shall not exceed one
(1) year;
(ii) A fine of not less than Fifty Thousand Pesos (Php50,000.00), but
not more than Five Hundred Thousand Pesos (PhP500,000.00). An
additional fine of not more than One Thousand Pesos (PhP1,000.00)
shall be imposed for each day of continuing violation;
4/21/2020, 9:19 AM
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