Panduan Umum Jenis Lesen/Kebenaran yang Diperlukan untuk Pengimportan (Senarai Tertakluk kepada Pindaan)

FARMASEUTIKAL

Ubat-ubatan termasuk premix yang dikawal di bawah Akta Racun 1952 (kegunaan manusia/ veterinar)

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Lain ubat-ubatan (OTC, suplemen kesihatan, tradisional -kegunaan manusia sahaja)

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Bahan psikotropik dan dadah berbahaya (DD) (kegunaan manusia/ veterinar)

Ubat Bahan mentah Test kit

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√ (DD)

Produk darah √ √ √

Ubat tidak berdaftar yang memerlukan kebenaran khas/ pengecualian import (kegunaan manusia/ veterinar)

Ubat dikawal di bawah Akta Racun 1952 Ubat tidak dikawal di bawah Akta Racun 1952

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BAHAN KIMIA

Bahan kimia dalam Jadual Pertama Akta Racun 1952 untuk kegunaan farmaseutikal/ industri

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Natrium hidroksida (NaOH) sahaja √

Mercury √ @ √ √

Acetyl Bromide/ Acetyl Chloride √ √

Arsenic Trichloride √ @ √ √

Caffein & its salts √ @ √ √

Clenbuterol, Formoterol, Salbutamol, Salmeterol, Terbutaline √ √

Nicotine & its salts √ √

Phosphorus √ @ √ √

Polymyxin termasuk colistin √ @ √ √

Prekursor Acetic anhydride*

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Ephedrine and its salts(termasuk produk)* √ √

Ergometrine (INN) & its salts* √ √

Ergotamine (INN) & its salts* √ √

Lysergic acid & its salts* √ @ √ √

Norephedrine & its salts* √ √

Pseudoephedrine & its salts (termasuk produk)* √ √

Alpha-Phenylacetoacetonitrile (APAAN) √ @ √ √

Isosafrole √ @ √ √

N-acetylanthranilic acid √ @ √ √

Phenylacetic acid & its salts √ @ √ √

Phenylacetone / Phenylpropan-2-one /1-phenyl-2-propanone √ @ √ √

Piperonal √ @ √ √

Potassium permanganate √ @ √ √

Safrole √ @ √ √

1-(1,3-Benzodioxol-5-yl)propan-2-one /3,4-methylenedioxyphenyl-2-propanone

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N-phenethyl-4-piperidinone (NPP) √ @ √ √

4-anilino-N-phenethylpiperidine (ANPP) √@ √ √

Bahan kimia bukan racun Hypophosphoric acid/ Hypophosphorous acid

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VETERINAR (TAMBAHAN KEPADA FARMASEUTIKAL)

Lain ubat-ubatan/ persediaan OTC dengan tuntutan perubatan kepada veterinar

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Makanan haiwan mengandungi antibiotik (kecuali antibiotik yang dilarang)

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KOSMETIK

Kosmetik √

LAIN-LAIN

Mesin membuat ubat √

PANDUAN PENGIMPORTAN BARANG-BARANG KAWALAN

BAHAGIAN PENGUATKUASAAN FARMASI (BPF) KEMENTERIAN KESIHATAN MALAYSIA (KKM)

MELALUI PINTU MASUK UTAMA KASTAM

(Pindaan Jun 2020)

Kod Tarif yang Dikawal oleh BPF, KKM

BAB KOD HS DESKRIPSI

12 12.11 Plants and parts of plants (including seeds and fruits), of a kind used primarily in perfumery, in pharmacy or for insecticidal, fungicidal or

similar purposes, fresh, chilled, frozen or dried, whether or not cut, crushed or powdered.

21 2106.90.71 00 Food supplements based on ginseng

2106.90.72 00 Other food supplements

2106.90.96 00 Other medical foods

22 2208.90.10 00 Medicated samsu of an alcoholic strength by volume not exceeding 40% vol.

2208.90.20 00 Medicated samsu of an alcoholic strength by volume exceeding 40 % vol.

23 23.09 Preparations of a kind used in animal feeding.

25 25.28 Natural borates and concentrates thereof (whether or not calcined), but not including borates separated from natural brine; natural boric acid

containing not more than 85% of H3B03 calculated on the dry weight.

26 26.17 Other ores and concentrates

28 Semua Inorganic chemicals; organic or inorganic compounds of precious metals, of rare-earth metals, of radioactive elements or of isotopes

29 Semua Organic chemicals

30 Semua Pharmaceutical products 33 33.01 Essential oils (terpeneless or not), including concretes and absolutes; resinoids; extracted oleoresins; concentrates of essential oils in fats, in

fixed oils, in waxes or the like, obtained by enfleurage or maceration; terpenic by-products of the deterpenation of essential oils; aqueous

distillates and aqueous solutions of essential oils.

33.02.90.00 00 Other (Mixtures of odoriferous substances and mixtures with a basis of one or more of these substances, of a kind used as raw materials in

industry; other preparations based on odoriferous substances, of a kind used for the manufacture of beverages)

3303.00.00 00 Perfumes and toilet waters.

33.04 Beauty or make-up preparations and preparations for the care of the skin (other than medicaments), including sunscreen or sun tan prepara-

tions; manicure or pedicure preparations.

33.05 Preparations for use on the hair.

33.06 Preparations for oral or dental hygiene, including denture fixative pastes and powders; yarn used to clean between the teeth (dental floss), in

individual retail packages.

3307.10.00 00 Pre-shave, shaving or after-shave preparations

3307.20.00 00 Personal deodorants and antiperspirants

3307.30.00 00 Perfumed bath salts and other bath preparations

3307.90.40 00 Other perfumery or cosmetics, including depilatories

34 3401.11.40 00 Medicated soap including disinfectant soap

3401.11.50 00 Other soap including bath soap

3401.20.20 00 Soap in other forms: Soap chips

3401.30.00 00 Organic surface-active products and preparations for washing the skin, in the form of liquid or cream and put up for retail sale, whether or not

containing soap

38 3807.00.00 00 Wood tar; wood tar oils; wood creosote; wood naphtha; vegetable pitch; brewers' pitch and similar preparations based on rosin, resin acids or

on vegetable pitch.

3808.94 Disinfectants

38.10 Pickling preparations for metal surfaces; fluxes and other auxiliary preparations for soldering, brazing or welding; soldering, brazing or welding

powders and pastes consisting of metal and other materials; preparations of a kind used as cores or coatings for welding elec trodes or rods.

3811.11.00 00 Based on lead compounds

3822.00 Diagnostic or laboratory reagents on a backing, prepared diagnostic or laboratory reagents whether or not on a backing, other than those of

heading 30.02 or 30.06; certified reference materials.

38.24 Prepared binders for foundry moulds or cores; chemical products and preparations of the chemical or allied industries (including those

consisting of mixtures of natural products), not elsewhere specified or included.

81 81.06 Bismuth and articles thereof, including waste and scrap.

8110.10.00 00 Unwrought antimony; powders

Akta yang Dikuatkuasakan

1. Akta Racun 1952 dan Peraturan-peraturannya.

2. Akta Jualan Dadah 1952 dan Peraturan-

peraturannya.

3. Akta Dadah Berbahaya 1952 dan Peraturan-

peraturannya.

4. Akta Kastam 1967.

5. Perintah Kastam (Larangan Mengenai Import).

Carta Alir Proses Pengimportan

Dokumen yang perlu disertakan semasa berurusan adalah:-

i. Borang Ikrar Kastam

ii. Lesen/ Kebenaran import (dengan senarai keluaran yang

dibenarkan)/ Nota notifikasi kosmetik

iii. Senarai pembungkusan

iv. Bill of Lading/ Airway Bill

v. Invois pengimportan

vi. Keterangan barangan (jika perlu) cth SDS/ risalah/ label

Sebarang pertanyaan, sila hubungi:

Cawangan Penguatkuasaan Farmasi Negeri di

alamat seperti di bawah: Jalan Raja Syed Alwi, 01000, Kangar, PERLIS.

Telefon: 04-9765033

Jalan Kuala Kedah, Simpang Kuala, 05400 Alor Setar, KEDAH.

Telefon: 04-7741000

Aras 8, Bangunan Persekutuan, Jalan Anson, 10400

PULAU PINANG.

Telefon: 04-2292319

Bangunan No. JKR 3693, Hospital Bahagia Ulu Kinta, 31250 Tanjung

Rambutan, PERAK.

Telefon: 05-5337318

Tingkat 10, No 1, Wisma Sunway, Jalan Tengku Ampuan Zabedah C 9/

C, Seksyen 9, 40100 Shah Alam, SELANGOR.

Telefon: 03-51237333

Jalan Cenderasari, 50590, KUALA LUMPUR.

Telefon: 03-2268 7333

Jalan Rasah, 70300 Seremban, NEGERI SEMBILAN.

Telefon: 06-7664800

Tingkat 3, Wisma Persekutuan, Jalan Business City, Bandar MITC,

75450, MELAKA. Telefon: 06-2356999

D/A Hospital Permai Lama,

Jalan Persiaran Permai, 81200 Johor Bahru, JOHOR

Telefon: 07-235 5120

Jalan IM 4, Bandar Indera Mahkota, 25582 Kuantan,

PAHANG

Telefon: 09-5707737

Tingkat 8, Menara Yayasan Islam, Jalan Sultan Omar, 20300 Kuala

Terengganu, TERENGGANU.

Telefon: 09-6222627 / 09-6301722

Lot 125-130, Taman Maktab, Pengkalan Chepa, 16100 Kota Bharu,

KELANTAN.

Telefon: 09-7730586/ 09-77305761

Jalan Diplomatik Off Jalan Bako, 93050 Petra Jaya, Kuching,

SARAWAK.

Telefon: 082-473200

Tingkat 6, Rumah Persekutuan, Jalan Mat Salleh 88590

Kota Kinabalu, SABAH.

Telefon: 088-257258

Jalan Tanjung Teras, Peti Surat 81657, 87026 W.P. LABUAN.

Telefon: 087-411416 Senarai ini tertakluk kepada pindaan dari semasa ke semasa. Untuk keterangan lanjut, sila rujuk Perintah Duti Kastam yang terkini

(http://mysstext.customs.gov.my/tariff/)

*Pelepasan tertakluk juga kepada undang-undang lain yang berkuatkuasa.