undang-undang di bawah kkm berkaitan vape (cecair nikotin)

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  • UNDANG-UNDANGDI BAWAH KKM BERKAITAN

    VAPE (CECAIR NIKOTIN)

    9 DECEMBER 2015

    CIAST, SELANGOR

    Oleh:

    Desmond Chong

    Penolong Pengarah (Kanan) Farmasi

    CAWANGAN PENGUATKUASA FARMASI, BPF

    NEGERI SELANGOR

  • KANDUNGAN

    1) Vape and E-cigarrette

    2) Kawalan undang-undang semasa ke atas

    Nikotin

    3) Kesimpulan

  • VAPE /E-CIGARRETTE

    An electronic cigarette (EC, e-cig, or e-cigarette),

    personal vaporizer (PV), or electronic nicotine

    delivery system (ENDS) is a battery-powered

    vaporizer which simulates the feeling of smoking, but

    without tobacco combustion

    * E-cigarettes typically have a heating

    element which atomizes a liquid solution

    known as e-liquid.

    * E-liquids usually contain propylene glycol,

    glycerin, water, nicotine, and flavorings.

    Vape-peranti elektronik yang tidak mengandungi nikotin

  • KAWALAN KE ATAS E-CIG/VAPE

    As of 2014 electronic cigarettes had not been approved as a smoking cessation device by

    any government.(1).

    As of 2015, around two thirds of major nations have regulated e-cigarettes in some way.

    Regulation of e-cigarettes vary from across countries and states with no regulation to others

    banning them entirely

    Brazil, Singapore, the Seychelles, and Uruguay have banned e-cigarettes

    In Canada, they are technically illegal to sell, but this is generally unenforced and they are

    commonly available for sale Canada-wide.

    In the United Kingdom, the use and sale of e-cigarettes are legal.

    In the US, the use and sale of e-cigarettes are legal.

    WHO. "Electronic nicotine delivery systems" (PDF). pp. 113. Retrieved 28 August

    2014

  • KAWALAN KE ATAS E-CIG/VAPE

    Currently in the United States, the Food and Drug Administration (FDA) can regulate only

    e-cigarettes that manufacturers market as therapeutic.

    in April 2014, the FDA proposed a rule that would extend its tobacco authority to cover

    commercial sales of e-cigarettes as nontherapeutic tobacco products.[1] This FDA action

    focuses on e-cigarettes as a harm reduction strategy,

    In October 2014, the WHO Framework Convention on Tobacco Control acknowledged

    the need for regulation of e-cigarettes along the lines of policies concerning other

    tobacco products, including banning or restricting promotion, advertising, and

    sponsorship.[2]1.US Food and Drug Administration. Deeming tobacco products to be subject to the

    Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking

    Prevention and Tobacco Control Act; regulations on the sale and distribution of

    tobacco products and required warning statements for tobacco products. Available

    at:

    http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/Economi

    cAnalyses/UCM394933.pdf. Accessed December 11, 2014.

    2. . World Health Organization. WHO tobacco treaty makes significant progress

    despite mounting pressure from tobacco industry. Available at:

    http://www.who.int/mediacentre/news/releases/2014/cop6-tobacco-control/en/.

    Accessed December 11, 2014.

  • PETIKAN MEDIA

  • UNDANG-UNDANG DI BAWAH KKM BERKAITANNIKOTIN

    AKTA-AKTA DAN PERATURAN-PERATURANNYA

    1) Akta Racun 1952

    * Peraturan-peraturan Racun 1952

    2) Akta Jualan Dadah 1952

    * Peraturan-peraturan Kawalan Dadah Dan

    Kosmetik 1984

  • POISON"

    bermakna sebarang bahan yang dinamakan secara

    spesifik di dalam Jadual Pertama Akta Racun 1952

    iaitu Senarai Racun (Poisons List) dan termasuk

    sebarang persediaan, larutan, sebatian, campuran

    atau bahan asli yang mengandungi bahan tersebut,

    selain daripada persediaan yang dikecualikan atau

    artikel atau persediaan yang pada masa ini

    dimasukkan dalam Jadual Kedua Akta Racun 1952

  • NICOTINE-JADUAL PERTAMA AKTA RACUN 1952

  • SEK 13(A) AKTA RACUN 1952

    Section 13.

    Memiliki racun untuk tujuan jualan dan menjual racun yang melanggari akta adalah

    satu kesalahan.

    Mana-mana individu yang-

    (a) Memiliki racun untuk tujuan jualan; kecuali dia dilesenkan dibawah Akta ini

    untuk menjual racun tersebut atau diberikuasa di bawah Sek 18 untuk

    menjual atau membekal racun; or

    (b) menjual atau membekal racun dengan melanggari akta dan peraturan-

    peraturanya atau syarat-syarat lesen yang telah ditetapkan di bawah akta ini

    berkaitan jualan atau bekalan racun di dlm Bahagian atau Kumpulan Racun di

    dalam Senarai Racun; yang mana jualan atau bekalan tersebut adalah

    melanggari Akta ini.

  • SECTION 18. RESTRICTION ON THE SALE OF PART I POISONS GENERALLY.

    (1)Part I Poison shall not be sold or supplied to any person except-

    (a) by wholesale in accordance with section 15; or

    (b) by retail sale effected by or under the immediate personal

    supervision of a licensed pharmacist;

    Provided that a Group F Poison may be sold or under the immediate

    personal supervision of a listed seller as well as by a licensed

    pharmacist; or

    (c) as an ingredient of a dispensed medicine, by a registered

    medical practitioner, registered dentist or veterinary surgeon in

    accordance with section 19;

  • SECTION 19. SUPPLY OF POISONS FOR THE PURPOSE OF TREATMENT BY PROFESSIONAL

    MEN

    . (1) Any poison other than a Group A Poison may be sold, supplied or administered

    by the following persons for the following purposes-

    (a) a registered medical practitioner may sell, supply or administer such poison to his

    patient for the purposes of the medical treatment of such patient only;

    (b) a registered dentist Division I may sell, supply or administer such poison to his

    patient for the purposes of the dental treatment of such patient only; and

    (c) a veterinary officer may sell or supply such poison to his client for the purposes

    of animal treatment only.

  • SECTION 22. GROUP C POISONS

    Group C Poison shall not be sold or supplied by retail to any person

    except:

    (a) where the sale or supply of such poison, if it had been a Group

    B Poison, would have been authorized under or by virtue of, and is

    effected in accordance with section 21; or

    (b) as a dispensed medicine or an ingredient in a dispensed

    medicine.

  • HUKUMAN DI BAWAH AKTA RACUN 1952:

    Seksyen 32(2) Akta Racun 1952

    -Denda tidak melebihi RM3000.00 atau

    penjara tidak melebihi setahun atau kedua-

    duanya sekali

  • AKTA JUALAN DADAH 1952PERATURAN-PERATURAN KAWALAN DADAH

    DAN KOSMETIK 1984

  • REGULATION 2: INTERPRETATION OF PRODUCT

    "product" means

    (a) a drug in a dosage unit or otherwise, for use wholly or mainly

    by being administered to one or more human beings or animals

    for a medicinal purpose; or

    (b) a drug to be used as an ingredient of a preparation for a

    medicinal purpose.

  • AKTA JUALAN DADAH 1952(PERATURAN-PERATURAN KAWALAN DADAH &

    KOSMETIK 1984)

    Regulation 7.

    Prohibition against manufacture, sale, supply , importation, possession

    and administration.

    (1) Except as otherwise provided in these Regulations, no person

    shall manufacture, sell, supply, import or possess or administrator

    any product unless -

    (a) the product is a registered product;

  • Tahukah Anda?Semua Produk Ubat-ubatan yang

    dijual & digunakan di Malaysia hendaklah

    BERDAFTAR dengan Pihak Berkuasa

    Kawalan Dadah (PBKD), Kementerian Kesihatan Malaysia

  • KENAPA UBAT PERLU BERDAFTAR?

    Untuk memastikan:

    Selamat (memastikan produk tidak dicemari dengan

    bahan-bahan asing yang merbahaya seperti logam berat)

    Berkualiti (produk dikilangkan di premis berstatus GMP

    Good Manufacturing Practice)

    Berkesan (melalui kajian saintifik)

  • PRODUK BERDAFTAR MENGANDUNGI NICOTINE

  • HUKUMAN:SEKSYEN 12 AKTA JUALAN DADAH 1952

    -Individu-Denda tidak melebihi RM25,000.00

    atau penjara tidak melebihi 3 tahun atau

    kedua-duanya sekali

    -Badan korporat- Denda tidak melebihi RM

    50,000.00

  • E-LIQUID DISYAKI MENGANDUNGI NIKOTIN

  • KESIMPULAN

    1) Cecair Nikotin dikawal dibawah Akta Racun 1952

    2) Hanya Ahli Farmasi berrlesen dan pengamal perubatan

    berdaftar boleh membekalkan sediaan/produk nikotin.

    3) Sediaan/produk nikotin perlu berdaftar dengan Pihak

    Berkuasa Kawalan Dadah, KKM sebelum dipasarkan

    4) Penguatkuasaan ke atas cecair Nikotin akan dilaksanakan

    berdasarkan undang-undang sedia ada.

  • TERIMA KASIH