IMPERIAL, KLAREZZA JEDAYA G.

PAD 426
JURISPRUDENCE ACTIVITY

ADMINISTRATIV DATE SCOPE &

SUBJECT RATIONALE OBJECTIVES
E ORDER PUBLISHED COVERAGE
1 AO NO 2020- September Establishing It was made the policy of the This Order aims to: This Order
0045 22, 2020 Facilitated state that health products shall apply to
Registration made available in the 1. Define the all local drug
Pathways for country, including drugs or facilitated manufacture
Drug Products, medicines, are safe, registration routes; rs, traders,
including effective, and of good and
Vaccines and quality. 2. Identify the distributors,
Biologicals eligibility criteria for who intend
With the advent of the applicant and to place in
globalization and drug products; and, the local
improvements in market, drug
technology, the 3. Describe the products
development, production, arrangements to with existing
and distribution of health implement these and valid
products, including drugs mechanisms. approval/s
and medicines, have become from
more interconnected across reference
countries. In turn, regulatory drug
oversight for the safety, regulatory
efficacy, and quality of agencies,
health products have and/or
become shared among existing and
different national valid
regulatory authorities registration
(NRAs) under
recognized
collaborative
registration
procedures

2 AO No. 55 s. December Requirements In pursuant to the "Foods, This Order aims to: This Order
1988 7, 1988 for labelling Drugs and Devices, and shall apply to
product Cosmetics Act" and the 1. To Know the all local drug
materials of "Generics Acts of 1998", it proper way of manufacture
pharmaceutical is required that the generic labelling drugs rs, traders,
products name shall be the one with and
the highest point size 2. To know the distributors,
among the printed appropriate who intend
material to be used to place in
elements of the label,
for labelling drugs the local
printed in full and enclosed
market, drug
exclusively by an outlined
products
box. If the product is
with existing
identified by a brand name and valid
shall be one point size approval/s
bigger but in the same from
typeface, font and color as reference
the brand name and shall drug
appear immediately above
the latter
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 regulatory
agencies,
3 AO No. 56 s. January 3, Revised This is all about the revising It aims to have a This Order
1989 1989 Regulations for the regulations for the competent and shall apply to
the licensing of licensing of Drug standard of Drug all local drug
Drug establishments and Outlets. establishments and manufacture
establishments Outlets rs, traders,
and Outlets and
distributors,
who intend
to place in
the local
market, drug
products
with existing
and valid
approval/s
from
reference
drug
regulatory
agencies
4 A.O. 62 s. 1989 March Rules and This is all about prescribing This Order Aims to: It will apply
15,1989 Regulations to of Drugs with always to registered
Implement included the Generic Name 1. To know the local drug
Prescribing under the RA No. 6675. And Requirements for outlet and
Requirements to know the rules and prescribing and hospital with
under the regulation of proper identify the proper existing and
Generics Act of prescription prescription. valid
1988 (R.A. No. approval/s
6675) from
reference
drug
regulatory
agencies,
5 A.O. 63 s. 1989 March Rules and This is all about dispensing This Order Aims to: It will apply
16,1989 Regulations to of Generics Drugs under the to registered
Implement RA No. 6675. And to know 1. Proper way of local drug
Dispensing the rules and regulation of dispensing a Generic outlet and
Requirements dispensing the Generic Drugs hospital with
under the Drugs, existing and
Generics Act of 2. To know more valid
1988 (R.A. No. about Generic Drug approval/s
6675) Dispensing from
reference
drug
regulatory
agencies,
6 A.O. 67 s. 1989 March 15, Revised Rules This is for the Products to be 1. provide This Order
1989 and Regulation registered and also the additional shall apply to
on Registration regulation of Pharmaceutical guidelines that all local drug
of Products. would reinforce the manufacture
Pharmaceutical implementation rs, traders,
Products of AO 67 s. 1989 and
distributors,
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 2. Further amend who intend
the existing rules to place in
and regulations in the local
the registration of market, drug
new pharmaceutical products
products to align with existing
with the recently and valid
promulgated laws approval/s
and adopted from
policies reference
drug
regulatory
agencies
7 AO NO.99 s. December Requirements All multi active-ingredient To know more All drug
1990 03, 1990 for labelling pharmaceutical products about the establishme
materials of containing four or more requirements of la nts that own
category of active ingredients not labelling materials registered
pharmaceutical covered by A.O. 85 s. 1990, of category of drug
products are covered by this A. O pharmaceutical products
containing four products containing covered
or more active four or more active under this
ingredients ingredients . A.O shall
outside the present their
coverage of proposed
A.O. 85 s. 1990. generic
labels in
compliance
with the
above for
review and
approval by
BFAD
8 AO NO.184 s. December Guidelines on R.A. 3720 known as the To promulgated This Order
2004 28, 2004 the “Food, Drug and Cosmetic governing the shall be,
Registrations of Act", amended by Sections registration of drugs applicable to
Traditionally- .4“and 19 of E.O.”175 (An herein as all
Used of Herbal ‘Act to Ensure the Safety and traditionally-used traditionally-
Products Purity of Foods and herbal products used herbal.
Cosmetics, And the Purity, products”
Safety, Efficacy and Quality except as
of Drugs and Devices Being provided
Made. the following herein
regulations” are hereby
promulgated governing the 1.Medicines/
registration of drugs herein drugs that
defined as traditionally-used do not fall
herbal products. within the
definition of
traditionally-
used” "
herbal
products
cited in this
regulation
shall be
governed by
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 other
Regulations
promulgated
for other
herbal
products in
genera.
9 AO 27 s. 2001 June 19, RULES AND Pursuant to the provisions of To proper licensing This Order
2001 REGULATIONS the Republic Act No. 3720, the vaccines and shall apply to
FOR LICENSING otherwise known as Food, biologics products all local drug
LOCAL Drugs and Devices, and and following rules manufacture
MANUFACTURE Cosmetic Act, as amended and regulations on rs, traders,
RS OF VACCINES by the Executive Order No. licensing of local and
AND BIOLOGIC 175, the following rules and manufacturers. distributors,
PRODUCTS regulations on licensing of who intend
local manufacturers of to place in
vaccines and biological the local
products are hereby market, drug
adopted and promulgated products
for information, guidance, with existing
and compliance of all and valid
concerned approval/s
from
reference
drug
regulatory
agencies
10 AO 103 s. 2002 April 23, BATCH effectivity of this Order, all to speed up the This Order
2002 CERTIFICATION kinds of antibiotic and delivery of its shall apply to
OF ANTIBIOTICS antibiotic containing services, these all local drug
products, whether in bulk, guidelines are manufacture
semi-finished or finished issued to reinforce rs, traders,
form and whether the principle that and
imported or domestically the ultimate distributors,
produced are no longer responsibility of who intend
subject to batch ensuring the quality, to place in
safety and efficacy the local
certification subject to
of pharmaceutical market, drug
certain exceptions
products rests with products
provided hereunder before
the manufacturers, with existing
it can enter the country or traders, distributors and valid
can be released for sale. and/or product approval/s
owner. from
reference
drug
regulatory
agencies
REFERENCE FOR:

• https://www.fda.gov.ph/wp-content/uploads/2020/10/Administrative-Order-2020-0045.pdf
• file:///C:/Users/HP-14/Downloads/145880175-ao-55-1988.pdf
• https://www.academia.edu/21802538/JURIS_2015
• file:///C:/Users/HP-14/Downloads/312572831-ao-99-s-1990.pdf
• https://www.coursehero.com/file/37912187/AO-27-s-2001pdf/
• https://www.fda.gov.ph/wp-content/uploads/2021/04/Administrative-Order-No.-103-s.-2002.pdf
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