Pemeriksaan pengimportan barangbarang oleh Bahagian Perkhidmatan Farmasi di setiap pintu masuk Kastam adalah untuk memastikan semua pengimportan
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- Ernest Richards
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3 Pemeriksaan pengimportan barangbarang oleh Bahagian Perkhidmatan Farmasi di setiap pintu masuk Kastam adalah untuk memastikan semua pengimportan berkenaan adalah mematuhi Undang-Undang yang dikuatkuasakan oleh Bahagian Perkhidmatan Farmasi Kementerian Kesihatan Malaysia.
4 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
5 Ubat-ubatan / produk farmaseutikal Produk racun / bukan racun, termasuk health / dietary supplements Bahan bahan kimia Keluaran kosmetik Keluaran veterinar Keluaran Tradisional
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8 Kod Tarif (TC) yang dikawal oleh Bahagian Perkhidmatan Farmasi 12, 21, 22, 23, 25, 26 plant parts, food preparations, medicated samsu, borates 28 Inorganic Chemicals 30 Pharmaceuticals products 81 Bismuth ; antimony 29 Organic Chemicals 33 Cosmetics 38 Wood tar, disinfectants 40 Pharmaceutical articles, catheters 34 Disinfectant or medicated soaps
9 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
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11 Terdapat 4 Akta Farmasi yang dikuatkuasa di negara ini: Akta Racun 1952 dan Peraturan-peraturannya Akta Jualan Dadah 1952 dan Peraturanperaturan Kawalan Dadah dan Kosmetik 1984 Akta Dadah Berbahaya 1952 dan Peraturanperaturannya Akta Ubat (Iklan dan Jualan)1956 dan Peraturan-peraturannya
12 Akta Racun 1952 dan Peraturan-peraturannya Sect 8(1) Control of Imports of Poisons No person other than a person licensed under this Act shall import any poison from any place outside Malaysia Sect 8(2)(a) This section does not apply to Any person arriving in Malaysia from a place outside Malaysia who imports, as part of his personal luggage and solely for his personal use or for the use of his family, a prepared or packaged medicine containing any poison, not exceeding such quantities as may be reasonably required for one month s use by one person Sect 8(2) (b) Any person importing a prepared or packaged medicine containing any poison for his own personal use or for that of his family by letter or parcel post, in such quantities and subject to such conditions as may be prescribed by regulations made under this Act
13 Akta Jualan Dadah 1952 dan Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 Regulation 7(1) Except as otherwise provided in these Regulations, no person shall manufacture, sell,supply, import,possess or administer any product unless - a) the product is a registered product; and b) the person holds the appropriate license required and issued under these Regulations Regulation 7(3) The provisions of sub-regulation (1) relating to importation do not apply to any person arriving in the Federation from a place outside the Federation who imports, as part of the his personal luggage any product meant solely for his use or for the use of his family in a quantity not exceeding that which may be reasonably required for one month s use by one person, or to any officer of the Government importing any product in the course of his duty, or to any person who, in accordance with the written consent of the Authority, brings any product into the Federation in transit
14 Akta Jualan Dadah 1952 dan Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 Regulation 7(1) Except as otherwise provided in these Regulations, no person shall manufacture, sell,supply, import,possess or administer any product unless - a) the product is a registered product; and b) the person holds the appropriate license required and issued under these Regulations Regulation 7(3) The provisions of sub-regulation (1) relating to importation do not apply to any person arriving in the Federation from a place outside the Federation who imports, as part of the his personal luggage any product meant solely for his use or for the use of his family in a quantity not exceeding that which may be reasonably required for one month s use by one person, or to any officer of the Government importing any product in the course of his duty, or to any person who, in accordance with the written consent of the Authority, brings any product into the Federation in transit
15 Peraturan peraturan Kawalan Dadah dan Kosmetik 1984 (CDCR 1984) DEFINISI KOSMETIK Cosmetic means any substance or preparation intended to be placed in contact with the various external parts of human body (including epidermis,hair system,nails,lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them,perfuming them,changing their appearance or correcting body odours,protecting them or keeping them in good condition.
16 Peraturan peraturan Kawalan Dadah dan Kosmetik 1984 (CDCR 1984) Kawalan Pengimportan Keluaran Famaseutikal p.7 (1) (a) Keluaran perlu berdaftar p.7 (1) (b) Lesen yang sesuai Import keluaran untuk percubaan klinikal P.12 (1) (c) Import keluaran keluaran berdaftar p.12 (1) (d) Lesen pengimport P.31 (1) Kuasa Menteri
17 Akta Dadah Berbahaya 1952 dan Peraturan-peraturannya DEFINISI DADAH BERBAHAYA Menurut Seksyen 2 Akta Dadah Berbahaya 1952: Apa-apa bahan yang telah disenaraikan di dalam Jadual Pertama di dalam Akta Dadah Berbahaya Bahagian I: Raw Opium Bahagian IV* : Dihydrocodeine, Bahagian II : Prepared Opium Pholcodeine, Propiram, Codeine Bahagian III* : Cocaine, Morphine, Heroin, Ketamine, Methadone dll *senarai ini berubah dari masa ke semasa CONTOH DADAH BERBAHAYA AKTA DADAH BERBAHAYA 1952 (DISEMAK 1989) Kawalan Import/Eksport Dadah Berbahaya (S. 12) Kebenaran Eksport Dadah Berbahaya S.19(2) Kebenaran Import Dadah Berbahaya S. 20 (1)
18 1 2 3 Akta Dadah Berbahaya 1952 dan Peraturan-peraturannya DEFINISI BAHAN PSIKOTROPIK Bahan Psikotropik ialah racun-racun berjadual seperti yang disenaraikan dalam Jadual Ketiga Akta Racun *senarai ini berubah dari masa ke semasa CONTOH BAHAN PSIKOTROPIK Amfepramone Barbituric acid Buprenorphine Diazepam & other substnces structurally derived from 1,4 benzodiazepine Zolpidem Zolpiclone AKTA DADAH BERBAHAYA 1952 (DISEMAK 1989) Kawalan Import & Eksport Bahan Psikotropik (S.30 Akta Racun 1952) Kebenaran Import [ p.5, PR (BP) 1989) ] Kebenaran Eksport [ p.6, PR (BP) 1989) ]
19 Hukuman Pada Kesalahan Pertama Mana-mana kesalahan dibawah Peraturan peraturan dibawah Akta Jualan Dadah (Pindaan) Seksyen 12 : Individu Denda sehingga RM 25, atau penjara tidak lebih 3 tahun atau kedua-dua Korporat Denda sehingga RM 50, Akta Racun 1952 Sek 32(2) bagi racun : Denda RM 5, atau dua tahun penjara atau kedua-duanya Akta Racun 1952 Sek 30(5) bagi bahan psikotropik : Denda sehingga RM 10, atau empat tahun penjara atau keduaduanya
20 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / AJEN PEGAWAI FARMASI GALERI
21 Akta Kastam 1967, Perintah Kastam (Larangan Mengenai Import / Eksport) perlu kelulusan AP dari Pengarah / Timbalan Pengarah Perkhidmatan Farmasi Bahan kawalan yang perlukan permit kawalan Prekursor (Precursors) B-agonist
22 Kawalan Bahan Kimia Prekursor (Precursors) DEFINISI PREKURSOR Prekursor dan bahan-bahan kimia perlu adalah bahan-bahan yang boleh digunakan untuk pengilangan haram dadah narkotik dan bahan psikotropik
23 Kawalan Bahan Kimia Prekursor (Precursors) Table I Substance N-acetylanthranilic acid Ephedrine Ergometrine Ergotamine Isosafrole Lysergic acid Acetic anhydride 1-phenyl-2-propanone Piperonal Pseudoephedrine Safrole Alpha-Phenylacetonitrile CONTOH PREKURSOR Table II Substance Acetone Anthranilic acid Ethyl ether Hydrochloric acid Methyl ethyl ketone Piperidine Sulphuric acid Toluene A fine of not less than ten times the value of goods or RM 10,000 which is less and not more than ten times the value of goods or RM 10,000 which is more
24 Kawalan Bahan Kimia Prekursor (Precursors) CONTOH PROSES PREKURSOR Phenylacetic acid Ephedrine / pseudoephedrine 1-Phenyl-2-propanone Methamphetamine Amphetamine Hydrochloric acid Sulphate salt Hydrochloric salt
25 Serbuan di Lunas, Kedah pada 9 Julai 2006 Tangkapan (21) Orang Ahli Sindiket Rampasan 112 Kg Syabu 100,000 Biji Pil Ecstasy
26 Serbuan di Senai, Johor pada 4 Mac 2009 Tangkapan (6) Warga Mexico (4) Warga Singapura (1) Kanada Rampasan 215 Kg Syabu 48.5 Kg Ketamine
27 Serbuan di Johor Bahru pada 24 Januari 2009 Tangkapan (10) Orang Ahli Sindiket Rampasan 547 Kg Erimin Kg Serbuk Erimin 5
28 Rampasan Syabu di Kota Kinabalu Sabah Prekursor : Pseudoephedrine Acetone
29 Kawalan Bahan Kimia B-Agonist CONTOH B-Agonist Clenbuterol, Salbutamol, Salmeterol, Terbutaline, Formaterol Perlu Permit Kebenaran Import bagi pengimportan barangan di atas dan Lesen Racun
30 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
31 Seksyen 26(2)(a) Akta Racun Dikeluarkan kepada ahli farmasi berdaftar untuk mengimport, menyimpan dan menjual secara borong dan runcit atau borong sahaja atau runcit sahaja semua jenis racun berjadual. Boleh mengilang, menjual premixes, water soluble powder & injeksi untuk kegunaan veterinar. Hanya satu lesen bagi setiap individu. Lesen sah sehingga 31 Disember tahun semasa. Bayaran: Percuma Syarat-syarat tambahan tertakluk kepada Pegawai Pelesenan Negeri iaitu Pengarah Kesihatan Negeri.
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33 Seksyen 26(2)(b) Akta Racun Dikeluarkan kepada pemohon yang sesuai bagi sebuah syarikat untuk mengimport, menyimpan dan mengguna ATAU untuk tujuan mengimport, menyimpan dan menjual secara borong racun (selain daripada Kumpulan A) seperti yang dinyatakan dalam lesen. Lesen racun jenis B boleh dibahagikan kepada 3 kelas premis iaitu: Premis yang berhubung dengan bahan-bahan kimia makmal. Premis yang berhubung dengan kimia perindustrian. Premis yang mengilang & menjual secara borong makanan ternakan yang mengandungi antibiotic & anti infektif Bayaran: RM 100 Lesen sah sehingga 31 Disember tahun semasa.
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36 Seksyen 26(2)(e) Akta Racun Dikeluarkan kepada pemohon yang sesuai untuk mengimport, menyimpan dan mengguna sendiri Sodium Hidroksida dalam kuantiti yang dibenarkan. Ada dalam 2 bentuk: pepejal dan cecair Bayaran: RM 100 Lesen sah sehingga 31 Disember tahun semasa.
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38 Juga dikenali sebagai Natrium Hidroksida atau Caustic Soda. Singkatan nama: NaOH Dikeluarkan kepada pemohon untuk membeli Sodium Hidroksida dari pasaran tempatan, menyimpan dan mengguna sendiri dalam kuantiti yang dibenarkan. Ada dalam 2 bentuk: pepejal dan cecair. Bayaran: RM 20 Lesen sah sehingga 31 Disember tahun semasa.
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43 Kebenaran Import Dadah Berbahaya Kebenaran Psikotropik
44 Permit Ubat Bukan Berdaftar Kebenaran Import Test Kit Dadah Berbahaya
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46 Kebenaran Import Test Kit Psikotropik
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48 Lesen Import Percubaan Klinikal
49 Perlaksanaan Notifikasi Kosmetik Arahan Di bawah Peraturan 29 peraturan-peraturan kawalan dadah dan kosmetik 1984 Bilangan 1 Tahun 2007
50 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
51 Perlaksanaan Pendaftaran Produk Veterinar bermula pada 1 Ogos (Semua Kategori Produk) Pelesenan (pengilang, pengimport dan pemborong) berkuatkuasa mulai 1 Julai Semua persediaan veterinar yang mengandungi drug/bahan yang bertujuan untuk digunakan atau boleh diguna atau dituntut untuk tujuan perubatan perlu berdaftar dengan Pihak Berkuasa Kawalan Dadah (PBKD).-LESEN IMPORT Produk yang dikategorikan sebagai bahan tambahan makanan haiwan (feed additives) adalah dikawal di bawah Akta Makanan Haiwan 2009 (*termasuk produk suplemen kesihatan / supplements dan herba/natural mulai 1hb Julai 2014)
52 Kargo - kod tarif yang diperiksa Bab Kod Deskripsi Dokumen Sokongan Plants used in pharmacy Invois, risalah Other food preparation not elsewhere specified or included Risalah (% bahan), lesen import Samsu (including medicated samsu) Lesen import, risalah Preparation of a kind used in animal feeding Risalah, lesen A/B, nota notifikasi vet Natural borates and concentrate thereof (whether or not calcined) Lesen B, risalah/ MSDS Other ores and concentrates MSDS 28 All Inorganic chemicals, organic and inorganic compounds of precious metals of rare earth metals of radioactive elements or of isotops MSDS, Lesen A/B 29 All Organic chemicals MSDS, Lesen A/B 30 All Pharmaceuticals products Lesen A, lesen mengimport
53 Bab Kod Deskripsi Eye make up preparations Beauty make up preparations Preparation for use on the hair Preparation for oral or dental hygiene, including denture fixatives pastes and powders Other perfumery or cosmetics, including depilatories Dokumen Sokongan Nota notifikasi kosmetik, exemption Medicated or disinfectant soaps Other Nota notifikasi kosmetik, exemption Bismuth Antimony MSDS/ LESEN B
54 sambungan Bab Kod Deskripsi Weed tar, wood tar oils, wood creosote, wood naphta, vegetable pitch, brewer s pitch and similar preparations based on resin, resin acids or on vegetable pitch Deodorizing preparations having the character of insecticides Disinfectants Antiknock- based on lead compounds Composite diagnostic or laboratory reagents Prepared binders for foundry moulds or cores; chemical products and preparation of chemical or allied industries Insect repellents Dokumen Sokongan MSDS/ LESEN B Hygienic or pharmaceutical articles-sheath contraceptives Cathethers Others RISALAH
55 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
56 Keperluan Undang- Undang Setiap barangan yang diimport mesti mematuhi keperluan undang berikut:- Keluaran(Produk) ubat, farmaseutikal, kesihatan mesti didaftar dengan Pihak Berkuasa Kawalan Dadah. Pengimport semua jenis barangan yang dikawal mesti mempunyai lesen atau kebenaran yang berkaitan Dokumen yang perlu disertakan semasa berurusan Lesen / Kebenaran Import ( dengan senarai keluaran yang dibenarkan import) Senarai Pembungkusan Bill of Lading/ Airway Bill Inbois pengimportan Keterangan Barangan (Jika perlu) Kebenaran import Dadah Berbahaya Bahan Psikotropik Lain-lain (Produk tidak Berdaftar, Test-kit Bahan Psikotropik/ Dadah Berbahaya & Keluaran Untuk Percubaan Klinikal)
57 Setiap syarikat agen penghantaran/kurier perlu dilesenkan di bawah Seksyen 13(2) Akta Perkhidmatan Pos Setiap syarikat agen forwarding/agen kastam diberikan kebenaran dan dikawal di bawah Seksyen 90 Akta Kastam 1967 Perlu mengikut segala peruntukkan undang-undang dikuatkuasakan di bawah akta ini. Peranan Agen Penghantaran/ Kurier Menyediakan dokumen berkaitan barangan yang dibawa masuk. Memaklumkan kepada penerima status barangan yang dihantar. Memaklumkan kepada penerima prosedur yang perlu diambil sekiranya barangan telah ditahan Segala aduan/rayuan perlu disalurkan kepada pejabat Bhg Perkhidmatan Farmasi Negeri yang terlibat.
58 Permohonan pengimportan & dokumen sokongan dikemukakan Makluman kepada konsaini / agen Tidak lengkap Permohonan disemak Lengkap Surat tahan dikeluarkan Tidak mematuhi keperluan undang-undang Memenuhi keperluan undang-undang Pemeriksaan fizikal (jika perlu) Penjelasan dikemukakan ke TPKN(F) Keputusan TPKN(F) Pengimportan diluluskan
59 1. Pengimport / konsaini / ejen mengemukakan permohonan pengimportan melalui program SMK. 2. Pengimport / konsaini / ejen perlu menyertakan segala dokumen sokongan. Jika tidak lengkap akan ditolak oleh pegawai farmasi 3. Pengimport / konsaini / ejen membawa sampel untuk pemeriksaan fisikal sekiranya perlu. 4. Jika mematuhi undang-undang pengimportan akan diluluskan didalam program SMK
60 5. Jika TIDAK mematuhi undang-undang, surat tahan / rampasan dikeluarkan oleh pegawai. 6. Penjelasan secara bertulis oleh pengimport / konsaini boleh dikemukakan ke Ibupejabat, Bahagian Perkhidmatan Farmasi di Shah Alam. 7. Sebarang keputusan ibu pejabat akan dimaklumkan secara bertulis kepada pegawai farmasi di pintu masuk dan kepada konsaini
61 Lesen / Kebenaran Import ( dengan senarai keluaran yang dibenarkan import) Senarai Pembungkusan Bill of Lading/ Airway Bill Inbois pengimportan Keterangan Barangan/MSDS (Jika perlu)
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63 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
64 Pelabuhan Utara & Pelabuhan Barat: Waktu Operasi: Isnin- Jumaat (8.00am 5.00pm) Sabtu (8.00am pm) Pelabuhan Utara
65 Tugas Menyaring semua pengimportan konsaimen yang dirujuk kpd Cawangan Penguatkuasa Farmasi sebelum kelulusan diberikan. Memberikan khidmat nasihat kepada pengimport berkenaan keperluan undang-undang bagi sesuatu konsaimen yang dikawal oleh Bahagian Perkhidmatan Farmasi.
66 Tugas Menjalankan pemeriksaan fizikal ke atas konsaimen yang mencurigakan atau memerlukan pemeriksaan yang lebih teliti sebelum kelulusan diberikan. Melaksanakan ON CALL terhadap konsaimen yang memerlukan kelulusan di luar waktu pejabat.
67 Tugas Menjalankan tindakan serbuan atau rampasan terhadap konsaimen yang didapati melanggar peruntukkan undang-undang Farmasi. Memberikan khidmat nasihat kepada pihak KASTAM berkenaan pengimportan yang melibatkan pihak FARMASI
68 BARANGAN YANG DIKAWAL OLEH FARMASI AKTA DAN HUKUMAN DADAH BERBAHAYA & BAHAN PSIKOTROPIK PERMIT KAWALAN BAWAH AKTA KASTAM LESEN DAN PERMIT VETERINAR PENGIMPORT / KONSAINI / EJEN PEGAWAI FARMASI GALERI
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73 Pendaftaran PBKD Lesen Jenis A Lesen Jenis B Lesen Jenis E Lesen Mengimport PBKD Kebenaran Kelulusan Import BPF, KKM Sijil Analisis Dari Negara Asal Pengecualian BPF, KKM Pengecualian PBKD Senarai Semak LESEN / KEBENARAN IMPORT KATEGORI BARANGAN 1. VETERINAR Ubat-ubatan kegunaan haiwan mengandungi racun berjadual Makanan ternakan haiwan mengandungi Beta Agonist : Clenbuterol Sabutamol Salmaterol Terbutaline Formaterol Ractopamine 2. TRADISIONAL Ubat Tradisional Senarai racun berjadual sila rujuk jadual 1 Akta Racun KOSMETIK Keluaran kosmetik NOTIFIKASI
74 Pendaftaran PBKD Lesen Jenis A Lesen Jenis B Lesen Jenis E Lesen Mengimport PBKD Kebenaran Kelulusan Import BPF, KKM Sijil Analisis Dari Negara Asal Pengecualian BPF, KKM Pengecualian PBKD sambungan LESEN / KEBENARAN IMPORT KATEGORI BARANGAN 4. BAHAN KIMIA Bahan kimia racun berjadual : Semua jenis Kimia Industri sahaja Sodium Hydroxide sahaja Prekursor dan Bahan Kimia Terkawal : Ephedrine, Pseudoephedrine, Norephedrine * Acetic Anhydride, Acetyl Chloride, Bromide Ergometrine () & its salts * Ergotamine & its salts Lysergic Acid & its salts * 1-Phenyl-2-Propanone Safrole Isosafrole Piperanole Potassium Permanganate N-Acetylantranilic Acid 3-4 Methylenedioxyphenyl-2-propanone
75 Pendaftaran PBKD Lesen Jenis A Lesen Jenis B Lesen Jenis E Lesen Mengimport PBKD Kebenaran Kelulusan Import BPF, KKM Sijil Analisis Dari Negara Asal Pengecualian BPF, KKM Pengecualian PBKD sambungan LESEN / KEBENARAN IMPORT KATEGORI BARANGAN 5. FARMASEUTIKAL Ubat-ubatan racun berjadual (kegunaan manusia) Ubat-ubatan bukan racun (kegunaan manusia) Suplemen kesihatan / makanan (Health/dietery supplements) Bahan Psikotropik & Dadah Berbahaya Ubat Bahan Mentah - - Produk berdarah (Blood Products) Bahan Mentah Farmaseutikal (racun berjadual) Caffeine Beta Agonist (bahan mentah) Ubat tidak berdaftar untuk penyakit yang mengancamkan nyawa : racun berjadual bukan racun - Sampel ubat tidak berdaftar yang mana pendaftaran telah dipohon : racun berjadual bukan racun -
76 Contact Detail Cawangan Penguatkuasa Farmasi, Wisma Kastam Pelabuhan Klang Utara Tel: Fax: Emel : northport.bpf@gmail.com ridzuan.hafiz@moh.gov.my
LEMBAGA JURUTERA MALAYSIA PENDAFTARAN ENGINEERING CONSULTANCY PRACTICE
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