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    Generics Act Report

    Uploaded by

    Shiela Mae Lopez
    - The document summarizes the key points of the "Generics Act of 1988" which aims to promote the use of generic drug terminology to ensure affordable drugs and make them available to those in need. It outlines requirements for generic drug production, labeling, education, and penalties for non-compliance.

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    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd

    Generics Act Report

    Uploaded by

    Shiela Mae Lopez
    269 views18 pages
    - The document summarizes the key points of the "Generics Act of 1988" which aims to promote the use of generic drug terminology to ensure affordable drugs and make them available to those in need. It outlines requirements for generic drug production, labeling, education, and penalties for non-compliance.

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    generics act report

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    - The document summarizes the key points of the "Generics Act of 1988" which aims to promote the use of generic drug terminology to ensure affordable drugs and make them available to those in need. It outlines requirements for generic drug production, labeling, education, and penalties for non-compliance.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    269 views18 pages

    Generics Act Report

    Uploaded by

    Shiela Mae Lopez
    - The document summarizes the key points of the "Generics Act of 1988" which aims to promote the use of generic drug terminology to ensure affordable drugs and make them available to those in need. It outlines requirements for generic drug production, labeling, education, and penalties for non-compliance.

    Copyright:

    Attribution Non-Commercial (BY-NC)
    Download as PPT, PDF, TXT or read online from Scribd
    Download as ppt, pdf, or txt
    of 18

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    ÷ ÷÷   ÷ 
            
       ÷

    a  
      
    

    "Generics Act of 1988"


    — —
    
    - ao promote, encourage and require the use of
    generic terminology.
    - ao ensure the adequate supply of drugs with
    generic names at the lowest possible cost and to
    make them available for free to indigent patients.
    - ao encourage the extensive use of drugs with
    generic names through a rational system of
    procurement and distribution.
    - ao emphasize the scientific basis for the use of
    drugs.
    - ao promote drug safety.
    —       
    - Generic Name or Generic aerminology - is the
    identification of drugs and medicines by their
    scientifically and internationally recognize active
    ingredients.
    - Active Ingredient - is the chemical component
    responsible for the claimed therapeutic effect of the
    pharmaceutical product.
    - Chemical Name - is the description of the chemical
    structure of the drug.
    - Drug Product - is the finished product form.
    - Drug Establishment - is any organization or
    company involved in the manufacture, importation,
    repacking and/or distribution of drugs or medicines.
    - Drug Outlets - means drugstores.
    - Essential Drugs List/National Drug Formulary - is a
    list of drugs prepared and periodically updated by
    the Department of Health.
    - Core List - is a list of drugs that meets the health
    care needs of the majority of the population.
    - Complementary List - is a list of alternative drugs
    used when there is no response to the core
    essential drug or when there is hypersensitivity
    reaction.
    - Brand Name - is the proprietary name.
    - Generic Drugs - are drugs not covered by patent
    protection and which are labeled solely by their
    international non-proprietary or generic name.
    —    
         
    
    
      
       
    - —pecial consideration shall be given to drugs
    and medicines which are included in the
    Essential Drugs List to be prepared within
    one hundred eighty (180) days from approval
    of this Act and updated quarterly by the
    Department of Health on the basis of health
    conditions obtaining in the Philippines as well
    as on internationally accepted criteria.
    - ao promote through such a system of
    incentives as the Board of Investments jointly
    with the Department of Health and other
    government agencies as may be authorized
    by law, shall promulgate in accordance with
    existing laws, within one hundred eighty (180)
    days after approval of this Act.
    — !  
    "
    

    - 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.
    — #$—
      
       
    - All government health agencies and
    personnel.
    - All medical, dental and veterinary
    practitioners.
    - Any organization or company involved in the
    manufacture, importation, repacking,
    marketing and/or distribution of drugs and
    medicines.
    - Drug outlets.
    —   %   &
     '
    (
    
      )  
    * + " 

    - ahe label of all drugs and medicines shall


    have the following:
    - Ô  ÔÔ
      Ô   
        Ô   Ô Ô
    —   ,* -   

    - Every drug manufacturing company


    operating in the Philippines shall be
    required to produce, distribute and
    make available to the general public
    the medicine it produces, in the form
    of generic drugs.
    —   .* 
    * 
     

    - @ust be in accordance with the rules and


    regulations to be promulgated by the
    Department of Health.
    - 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 or in two (2)
    newspapers of general circulation.
    —   /01    + 
    - 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.
    - ahe President may authorize the importation of raw
    materials   Ô
     . ahe —ecretary of
    Health shall ensure that the imported raw materials
    are allocated  
     Ô Ô
    among Filipino-
    owned or controlled drug establishments. He shall
    submit to the Office of the President and to
    Congress a quarterly report on the  Ô
    Ô
    Ô  of the raw materials imported.
    —   // 
     
    - —hall conduct a continuous information
    campaign for the public and a continuing
    education and training for the medical and
    allied medical professions on drugs with
    generic names as an alternative of equal
    efficacy to the more expensive brand name
    drugs.
    - educational campaign shall include
    information on the illnesses or symptoms
    which each generically named drug is
    supposed to cure or alleviate, as well as its
    contraindications.
    —   /
     
    - Any person who shall violate —Ô   of
    this Act:
     for the first conviction, he shall suffer the penalty of
    reprimand which shall be officially recorded in the
    appropriate books of the Professional Regulation
    Commission.
     for the second conviction, the penalty of fine in the amount
    of not less than two thousand pesos (P2,000.00) but not
    exceeding five thousand pesos (5,000.00) at the discretion
    of the court.
     for the third conviction, the penalty of fine in the amount of
    not less than five thousand pesos (P5,000.00) but not
    exceeding ten thousand pesos (P10,000.00) and
    suspension of his license to practice his profession for thirty
    (30) days at the discretion of the court
     for the fourth and subsequent convictions, the penalty of
    fine of not less than ten thousand pesos (P10,000.00) and
    suspension of his license to practice his profession for one
    year or longer at the discretion of the court.
    - Any juridical person who violates —Ô  
      shall suffer the penalty of a fine of not less
    than five thousand pesos (P5,000.00) nor more than
    ten thousand pesos (P10,000.00) and suspension or
    revocation of license to operate such drug
    establishment or drug outlet at the discretion of the
    Court.
    - ahe —ecretary of Health shall have the authority to
    impose administrative sanctions such as suspension
    or cancellation of license to operate or recommend
    suspension of license to practice profession to the
    Professional Regulation Commission as the case
    may be for the violation of this Act.
    —   /— +
    
    " 
    

    - If any provision of this Act is declared


    invalid, the remainder or any provision
    hereof not affected thereby shall
    remain in force and effect.
    —   /* +
     
    

    - ahe provisions of any law, executive


    order, presidential decree or other
    issuances inconsistent with this Act
    are hereby repealed or modified
    accordingly.
    —   /!     

    - ahis Act shall take effect fifteen (15)


    days after its complete publication in
    the Official Gazette or two (2)
    newspapers of general circulation.

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