Pemberitahuan Pengecualian di Bawah Peraturan 31
The full official text, structured for quick navigation. Copy any provision or jump straight to a section.
- Enacted
- 2019
Pemberitahuan Pengecualian di Bawah Peraturan 31 is Malaysia P.U. (B), cited as P.U. (B) 103 2019, currently marked in force and first recorded in 2019.
Front matterCover and publication detailsOpenClose
P.U. (B) 103
WARTA KERAJAAN PERSEKUTUAN
FEDERAL GOVERNMENT
GAZETTE
PEMBERITAHUAN PENGECUALIAN
DI BAWAH PERATURAN 31
NOTIFICATION OF EXEMPTION
UNDER REGULATION 31
DISIARKAN OLEH/
JABATAN PEGUAM NEGARA/
ATTORNEY GENERAL’S CHAMBERS
P.U. (B) 103 2
AKTA JUALAN DADAH 1952
PERATURAN-PERATURAN KAWALAN DADAH DAN KOSMETIK 1984
PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31
Opening note
Preamble
- PADA menjalankan kuasa yang diberikan oleh peraturan 31 Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 [P.U. (A) 223/1984], Menteri, setelah berunding dengan Pihak Berkuasa, mengecualikan Rhone Ma Malaysia Sdn. Bhd. daripada pemakaian subperaturan 7(1) berhubung dengan penjualan, pembekalan, pengimportan dan pemilikan keluaran veterinar sebagaimana yang diperihalkan dalam Jadual berkuat kuasa mulai 1 Mac 2019 hingga 31 Disember 2021 tertakluk kepada syarat yang berikut:
(b)
keluaran itu hendaklah dijual, dibekalkan dan diimport tidak melebihi kuantiti yang dinyatakan dalam Jadual;
(c)
keluaran itu hendaklah diimport hanya bagi maksud dan kegunaan doktor veterinar berdaftar dan dibekalkan dan dijual semata-mata kepada doktor veterinar berdaftar;
(d)
suatu salinan borang import Kastam mengenai keluaran itu hendaklah dihantar dalam masa tiga puluh hari dari tarikh pengimportan kepada
Pengarah Kanan Perkhidmatan Farmasi, Kementerian Kesihatan bagi tiap-tiap pengimportan; dan
(e)
suatu laporan mengenai penjualan, pembekalan, pengimportan dan pemilikan keluaran itu hendaklah dihantar kepada Pengarah Kanan
Perkhidmatan Farmasi, Kementerian Kesihatan pada tiap-tiap bulan tidak lewat daripada lima belas hari bulan pada bulan yang berikutnya.
P.U. (B) 103 3
Jadual
JADUAL
Keluaran Yang Dikecualikan
1.
Nama Keluaran
Kuantiti
Previcox (57mg)
tablet kunyah untuk anjing
54,780 biji tablet
2.
Nexgard Spectra (9mg/2mg)
tablet kunyah untuk anjing 2-3.5kg
9,400 biji tablet
3.
Nexgard
Spectra
(19mg/4mg)
tablet kunyah untuk anjing melebihi 3.5-7.5kg
14,400 biji tablet
4.
Nexgard
Spectra
(38mg/8mg)
tablet kunyah untuk anjing melebihi 7.5-15kg
27,000 biji tablet
5.
Nexgard
Spectra
(75mg/15mg)
tablet kunyah untuk anjing melebihi 15-30kg
27,000 biji tablet
6.
Nexgard Spectra (150mg/30mg)
tablet kunyah untuk anjing melebihi 30-60kg
13,200 biji tablet
Bertarikh 28 Januari 2019
[KKM.R.600-1/3/72 Jld. 2 (6); PN(PU2)269A/V]
DATUK SERI DR. DZULKEFLY BIN AHMAD
Menteri Kesihatan
P.U. (B) 103 4
SALE OF DRUGS ACT 1952
CONTROL OF DRUGS AND COSMETICS REGULATIONS 1984
NOTIFICATION OF EXEMPTION UNDER REGULATION 31
IN exercise of the powers conferred by regulation 31
of the Control of Drugs and Cosmetics Regulations 1984 [P.U. (A) 223/1984], the
Minister, after consultation with the
Authority, exempts
Rhone Ma Malaysia Sdn. Bhd. from the application of subregulation 7(1) in relation to the sale, supply, importation and possession of the veterinary products as described in the Schedule with effect from 1 March 2019 to 31 December 2021 subject to the following conditions:
(a)
the products shall be imported only from the company of
Merial, Lyon, France;
(b)
the products shall be sold, supplied and imported not exceeding the quantity specified in the Schedule;
(c)
the products shall be imported only for the purposes and use of a registered veterinary surgeon and supplied and sold solely to a registered veterinary surgeon;
(d)
a copy of the Custom’s import form for every importation of the products shall be sent within thirty days from the date of importation to the
Senior Director of Pharmaceutical Services, Ministry of Health; and
(e)
a report on the sale, supply, importation and possession of the products shall be sent to the Senior Director of Pharmaceutical Services,
Ministry of Health every month not later than the fifteenth of the following month.
P.U. (B) 103 5
Jadual
Exempted Products
1.
Product Name
Quantity
Previcox (57mg)
chewable tablets for dogs
54,780 tablets
2.
Nexgard
Spectra
(9mg/2mg)
chewable tablets for dogs 2-3.5kg
9,400 tablets
3.
Nexgard Spectra (19mg/4mg)
chewable tablets for dogs more than 3.5-7.5kg
14,400 tablets
4.
Nexgard Spectra (38mg/8mg)
chewable tablets for dogs more than 7.5-15kg
27,000 tablets
5.
Nexgard Spectra (75mg/15mg)
chewable tablets for dogs more than 15-30kg
27,000 tablets
6.
Nexgard Spectra (150mg/30mg)
chewable tablets for dogs more than 30-60kg
13,200 tablets
Dated 28 January 2019
[KKM.R.600-1/3/72 Jld. 2 (6); PN(PU2)269A/V]
DATUK SERI DR. DZULKEFLY BIN AHMAD
Minister of Health
Common questions
- What is Pemberitahuan Pengecualian di Bawah Peraturan 31?
- Pemberitahuan Pengecualian di Bawah Peraturan 31 is Malaysia P.U. (B), cited as P.U. (B) 103 2019, currently marked in force and first recorded in 2019.
- Is Pemberitahuan Pengecualian di Bawah Peraturan 31 still in force?
- Yes — Pemberitahuan Pengecualian di Bawah Peraturan 31 is currently in force.
- When did Pemberitahuan Pengecualian di Bawah Peraturan 31 take effect?
- Pemberitahuan Pengecualian di Bawah Peraturan 31 was first recorded in 2019.
- How many schedules does Pemberitahuan Pengecualian di Bawah Peraturan 31 have?
- Pemberitahuan Pengecualian di Bawah Peraturan 31 contains 2 schedules.
- Where can I read the official version of Pemberitahuan Pengecualian di Bawah Peraturan 31?
- The official text of Pemberitahuan Pengecualian di Bawah Peraturan 31 is published at lom.agc.gov.my.
Something wrong on this page?
If one provision's text doesn't match the official source, use Suggest a fix beside that provision — it opens an editor next to the source document. For anything else — a missing amendment, a broken link, out-of-date content, or a removal request — report it here.