Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PHARMA > Republic Act of 1988 – Generics Act of 1988 > Flashcards

Republic Act of 1988 – Generics Act of 1988 Flashcards

1
Q

Generics Act of 1988

A

Republic Act 6675

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

Title – This Act shall be known as the Generics Act of 1988

A

SECTION 1

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

SECTION 3. Definition of Terms – The following terms are herein defined for
purposes of this Act:

A
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

is the identification of drugs
and medicines by their scientifically and internationally recognize active
ingredients or by their official generic name as determined by the Bureau of
Food and Drugs of the Department of Health.

A

“Generic Name of Generic Terminology”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

is the chemical component responsible for the
claimed therapeutic effect of the pharmaceutical product.

A

“Active Ingredient”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

” is the description of the chemical structure of the drug
or medicine and serves as the complete identification of a compound

A

“ Chemical Name”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

is the finished product form that contains the active
ingredients, generally but not necessarily in association with inactive
ingredients.

A

“Drug Product”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

” is any organization or company involved in the
manufacture, importation, repacking and/or distribution of drugs or medicines.

A

“ Drug Establishment”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

means drugstore, pharmacies, and any other business
establishments which sell drugs or medicines.

A

“Drug Outlets”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

” is a list of drugs
prepared and periodically updated by the Department of Health on bases of
health conditions obtaining in the Philippines as well as on internationally accepted criteria. It shall consist of a core list and a complementary list.

A

“Essential Drugs List”
or “National Drug Formulary”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

is a list of drugs that meets the health care needs of the
majority of the population.

A

“Core List”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

” is a list of alternative drugs used when there is no
response to the core essential drug or when there is hypersensitivity reaction
to the core essential drug or when for one reason or another, the core
essential drug cannot be given.

A

“Complementary List”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

” is the propriety name given by the manufacturer to
distinguish its product from those of competitors.

A

“Brand Name”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

are drugs not covered by patent protection and which
are labeled solely by their international non-proprietary or generic name.

A

“Generic Drugs”

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

– (a) In the promotion of the generic names for
pharmaceutical products, special consideration shall be given to drugs and
medicine which are included in the Essential Drugs List to be prepared within
one hundred are included in the Essential Drugs List,

A

SECTION 4. The use of Generic Terminology for Essential Drugs and
Promotional Incentives.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

The Department of Health shall
publish annually in at least two (2) newspapers of general circulation in the
Philippines the generic names, and the corresponding brand names under
which they are marketed, of all drugs and medicines available in the
Philippines.

A

SECTION 5. Posting and Publication –

11
Q

(a) All government health
agencies and their personnel as well as other government agencies shall use
generic terminology or generic names in all transactions related to
purchasing, prescribing, dispensing and administering of drugs and
medicines.

A

SECTION 6. Who Shall Use Generic Terminology –

12
Q

In order to assure responsibility for drug quality in all instances, the label of
all drugs and medicines shall have the following: name and country of
manufacture, dates of manufacture and expiration. The quality of such
generically labeled drugs and medicines shall be duly certified by the
Department of Health.

A

SECTION 7. Provision on Quality, Manufacturer’s Identity and Responsibility

13
Q

– Subject to the rules and regulations
promulgated by the Secretary of Health, every drug manufacturing company
operating in the Philippines shall be required to produce, distribute and make
available to the general to the general public the medicine it produces, in the
form of generic drugs.

A

SECTION 8 . Required Production

14
Q

The implementation of the provisions of
this Act shall be in accordance with the rules and regulations to be
promulgated by the Department of Health.

A

SECTION 9. Rules and Regulations

15
Q

Rules and regulations with penal sanctions shall be promulgated within one hundred eighty (180) days after approval of this Act and shall take effect fifteen (15) days after publication in the Official Gazette of in two (2) newspapers of general circulation.

A

SECTION 9. Rules and Regulations

16
Q

– Within three (3) years from effectively of
this Act, extendible by the President for another tow (2) years and during
periods of critical shortage an absolute necessity, the Department of Health is
hereby authorized to import raw materials of which there is a shortage for the
use of Filipino-owned or controlled drug establishments to be marketed and
sold exclusively under generic nomenclature

A

SECTION 10. Authority or Import –

17
Q

The Department of Health jointly with the
Department of Education, Culture and Sports, Philippine Information Agency
and Department of Local Government shall conduct a continuous information
campaign for the public and a continuing education and training for the
medical and allied medical professions and drugs with generic names as an
alternative of equal efficacy to the more expansive brand name drugs.

A

SECTION 11. Education Drive

18
Q

The Department of Health with the assistance of
the Department of Local Government at the Philippine Information
Agency shall monitor the progress of the education drive, and shall submit
regular reports to Congress.

A
19
Q

A) Any person who shall violate Section 6 (a) or 6 (b) of this Act shall suffer the penalty graduated hereunder, vizl:

A

SECTION 12. Penalty - A) Any person who shall violate Section 6 (a) or 6 (b)
of this Act shall suffer the penalty graduated hereunder, vizl:

20
Q

If any provision of this Act is declared invalid, the remainder or any provision hereof not affected thereby shall
remain in force and effect.

A

Section 13. Separability Clause

21
Q

The provisions of any law, executive order,
presidential decree or other issuances inconsistent with this Act are hereby
repealed or modified accordingly.

A

SECTION 14. Repealing Clause

22
Q

This Act shall take effect fifteen (15) days after its
complete publication in the Official Gazette or two (2) newspapers of general
circulation.

A

SECTION 15. Effectivity

23
Q
A

PHARMA (4 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions