Republic Act of 1988 - Generics Act of 1988 Flashcards
This act shall be known as the generics act of 1988
Section 1. Title
it is hereby declared the policy of the state
Section 2. Statement of policy
the following terms are herein defined for purposes of this act
Section 3. Definition of Terms
is the identification of drugs and medicines by their scientifically and internationally recognize active ingredients
Generic Name of Generic Terminology
is the chemical component responsible for the claimed therapeutic effect of the pharmaceutical product
active ingredient
is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound
chemical name
is the finish product form that contains the active ingredients, generally but not necessarily in association with inactive ingredient
drug product
is any organisation or company involved in the manufacture, repacking and/or distribution of drugs and medicines
drug establishment
means drugstore, pharmacies and any business establishments which sell drugs or medicinea
drug outlets
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
essential drugs list
is a list of drugs that meets the health care needs of the majority of the population
core list
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
complementary list
is the propriety name given by the manufacturer to distinguish its product from those of competitors
brand name
are drugs not covered by patent protection and which are labeled solely by their international non-proprietary or generic name
generic drugs
the use of generic terminology for essential drugs and promotional incentives. (a) in the promotion of generic names for pharmaceuticals product, special consideration shall be given to drugs and medicine which are included in the essential drug list to be prepared
Section 4