6675 Part 2

Question 1

__________________ shall take the necessary steps to ensure that all drugs authorized for marketing in the country shall conform to
international standards for the content, purity and quality of
pharmaceutical products as established in the International Pharmacopoeia:

Answer 1

BFAD

Question 2

imported products in finished dosage forms, should be certified under the __________________ certification scheme on the quality of pharmaceutical products moving in international commerce

Answer 2

World Health Organization (WHO)

Question 3

registration for multisource pharmaceutical products should conform to the ______________ on registration requirements to establish interchangeability

Answer 3

WHO guidelines

Question 4

refers to pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent

Answer 4

Multisource pharmaceutical products

Question 5

T/F: Multisource pharmaceutical products that are therapeutically equivalent are interchangeable

Answer 5

True

Question 6

T/F: Medicinal products are pharmaceutically equivalent if they contain the same amount of the same active substance(s) in the same dosage forms
that meet the same or comparable standards.

Answer 6

True

Question 7

T/F: Pharmaceutical equivalence does not necessarily imply bioequivalence

Answer 7

True

Question 8

are medicinal products with different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active moiety, or which differ in dosage form or strength.

Answer 8

Pharmaceutical alternatives

Question 9

Two pharmaceutical products are therapeutically equivalent if they are ___________________ and, after administration in the same molar dose, their effects with respect to both efficacy and safety are essentially the same, as determined from appropriate bioequivalence, pharmacodynamic, clinical, or in vitro studies.

Answer 9

pharmaceutically equivalent or alternatives

Question 10

A contract between government with innovator. In return for disclosing the invention to the public, the innovator receives the right to exclude others from practicing the invention for a limited period of time.

Answer 10

RIGHT TO MAKE AVAILABLE

Question 11

Right to make available is typically ___________ from filing the patent application

Answer 11

20 years

Question 12

Can discoveries, scientific theories, and mathematical methods be patented?

Answer 12

No

Question 13

T/F: Mere discovery of a new form or property of a known substance is not patentable if it doesn’t enhance the known substance’s efficacy.

Answer 13

True

Question 14

T/F: Mere discovery of any new property or use for a known substance is not patentable.

Answer 14

True

Question 15

T/F: Mere use of a known process is not patentable unless it results in a new product with at least one new reactant.

Answer 15

True

Question 16

T/F: Various derivatives of a known substance (salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, etc.) are considered the same substance unless they significantly differ in efficacy-related properties.

Answer 16

True

Question 17

What conditions allow a government agency or third party authorized by the government to exploit an invention without the agreement of the patent owner, specifically concerning drugs and medicines in the Philippines?

Answer 17

national emergency, public non-commercial use, demand for patented article is not being met

Question 18

___________may grant a license to exploit a patented invention, even without the agreement of the patent owner, in favor of any person who has shown his capability to exploit the invention

Answer 18

The Director General of the Intellectual Property Office

Question 19

Under what circumstance can the Director General of Intellectual property exploit a patented invention?

Answer 19

demand for patented drugs and medicines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health

Question 20

T/F: It shall be unlawful for any retail drug outlet to refuse to carry either by
sale or by consignment, or offer for sale drugs and medicines brought into
the country by the government or authorized third party which have been previously approved for distribution or sale by the Bureau of Food and Drugs

Answer 20

True

Question 21

products brought into the country by government or authorized third party shall be displayed with equal prominence as all other products sold in the establishment

Answer 21

True

Question 22

____________ shall have the power to impose maximum retail prices over any or all drugs and medicines

Answer 22

President of the Philippines (upon recommendation of the Secretary of the Department of Health)

Question 23

____________ authorized to establish and initiate a price monitoring and regulation system for drugs and medicines within ____________ days after the enactment of this Act.

Answer 23

Secretary of the Department of Health; 120 days

Question 24

____________ may also create such bodies, consultative councils, from which advice may be sought in the implementation of a drug or medicine price monitoring and regulation policy

Answer 24

Secretary of the Department of Health

Question 25

List of Drugs that are subject to price regulation:

Answer 25

1. chronic illnesses and life threatening conditions 2. indicated for prevention of diseases 3. indicated for prevention of pregnancy 4. Anesthetic agents 5. Intravenous fluids 6. included in the Philippine National Drug Formulary (PNDF) Essential Drug List 7. determined by Sec of DOH

Question 26

Drugs and medicines for treatment of chronic illnesses and life threatening conditions, such as, but not limited to:

Answer 26

a) endocrine disorders b) gastrointestinal disorders c) urologic disorders d) cardiovascular diseases e) pulmonary diseases f) auto-immune diseases g) skin diseases h) neuro-psychiatric disorders i) other infectious diseases, and other conditions such as organ transplants and neoplasm;

Question 27

Criteria for recommending MRP

Answer 27

Retail prices Supply available Cost to the manufacturer, importer, trader, distributor, wholesaler, or retailer

Question 28

T/F: labels under MDRP Control must include "Under Drug Price Regulation Retail Price Not To Exceed" in red font/red background

Answer 28

True

Question 29

RA _______ = Cheaper and Quality Medicines

Answer 29

9502

Question 30

RA 9502 ammends RAs ________, _________, ____________

Answer 30

8293, 6675, 5921

Question 31

RA 8293 is also called as

Answer 31

intellectual property code

Question 32

The consumer act of the philippines

Answer 32

RA 7394

Question 33

Price Act

Answer 33

RA 7581

Question 34

this act states that: Develop, adopt and promulgate measures to promote productivity in basic necessities and prime commodities;

Answer 34

RA 7581

Question 35

this act states that: Develop an improved and efficient transport and distribution system;

Answer 35

RA 7581

Question 36

Develop, adopt and promulgate measures to stabilize prices at reasonable levels;

Answer 36

RA 7581

Question 37

Institute appropriate penalties for illegal price manipulation and other violations of this Act and

Answer 37

RA 7581

Question 38

Establish a mechanism that will readily protect consumers from inadequate supply and unreasonable price increases on occasions of calamities, emergencies and like occurrences.

Answer 38

RA 7581

Question 39

T/F: hoarding, profiteering, or illegal combination or forming cartel is considered illegal by RA 7581

Answer 39

True

Question 40

the undue accumulation by a person or combination of persons of any basic necessity or prime commodity beyond his or their normal inventory levels or the unreasonable limitation or refusal to dispose of, sell or distribute the stocks of any basic necessity or prime commodity to the general public or the unjustified taking out of any basic necessity or prime commodity from the channels of production, trade, commerce, and industry.

Answer 40

Hoarding

Question 41

commodity from the channels of production, trade, commerce, and industry. There shall be prima facie evidence of hoarding when a person has stocks of any basic necessity or prime commodity _______________ higher than his usual inventory and unreasonably limits, refuses or fails to sell the same to the general public at the time of discovery of the stocks

Answer 41

fifty percent (50%)

Question 42

which is the sale or offering for sale of any basic necessity or prime commodity at a price grossly in excess of its true worth

Answer 42

Profiteering

Question 43

There shall be prima facie evidence of profiteering whenever a basic necessity or prime commodity being sold (profiteering):

Answer 43

has no price tag; is misrepresented as to its weight or measurement; is adulterated or diluted; or whenever a person raises the price of any basic necessity or prime commodity he sells or offers for sale to the general public by more than ten percent (10%)

Question 44

which is any combination of or agreement between two (2) or more persons engaged in the production, manufacture, processing, storage, supply, distribution, marketing, sale or disposition of any basic necessity or prime commodity designed to artificially and unreasonably increase or manipulate its price.

Answer 44

Cartel

Question 45

There shall be prima facie evidence of engaging in a cartel whenever _________ persons or business enterprises competing for the same market and dealing in the same basic necessity or prime commodity, perform uniform or complementary acts among themselves which tend to bring about artificial and unreasonable increase in the price of any basic necessity or prime commodity or when they simultaneously and unreasonably increase prices on their competing products thereby lessening competition among themselves

Answer 45

two (2) or more

Question 46

Penalty for Illegal Acts of Price Manipulation.

Answer 46

* imprisonment for a period of not less than five (5) years but not more than fifteen (15) years, or * fine of not less than Php100,000.00 but not more than Php10,000,000.00, at discretion court. * The court may also order the suspension or revocation of LTO, professional or business license