(a)
keluaran itu hendaklah diimport hanya daripada pengeksport yang dinyatakan dalam Jadual;
/akn/my/act/pub/2019/105
PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31
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- Type
- P.U. (B)
- Status
- In force
- Enacted
- 2019
- Sections
- 2
Quick answer
About this p.u. (b)
PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31 is Malaysia P.U. (B), cited as P.U. (B) 105 2019, currently marked in force and first recorded in 2019.
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 Elanco 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.
3
Jadual
JADUAL
Keluaran Yang Dikecualikan
Nama Keluaran
Kuantiti
Pengeksport
1.
Milbemax (4/10mg)
tablet bersalut nipis untuk kucing saiz kecil dan anak kucing
1,355,000
biji tablet
Elanco, Perancis
2.
Milbemax (16/40mg)
tablet bersalut nipis untuk kucing saiz kecil dan anak kucing
1,355,000
biji tablet
Elanco, Perancis
3.
Onsior (5mg) untuk anjing
2,310,000
biji tablet
Elanco, Perancis
4.
Onsior (10mg) untuk anjing
1,750,000
biji tablet
Elanco, Perancis
5.
Onsior (20mg) untuk anjing
1,750,000
biji tablet
Elanco, Perancis
6.
Onsior (40mg) untuk anjing
1,165,000
biji tablet
Elanco, Perancis
7.
Onsior (6mg) untuk kucing
6,725,000
biji tablet
Elanco, Perancis
8.
Onsior (20mg/ml)
larutan bagi suntikan untuk kucing dan anjing
70,000 vial
Bela-Pharm
GmbH & Co. KG,
Jerman
9.
Fortekor Plus (1.25mg/2.5mg)
untuk anjing
1,130,000
biji tablet
Lek
Pharmaceuticals,
Slovenia
4
10.
Fortekor Plus (5mg/10mg)
untuk anjing
1,340,000
biji tablet
Lek
Pharmaceuticals,
Slovenia
11.
Galliprant (20mg)
208,000
biji tablet
Argenta Limited,
New Zealand
12.
Galliprant (60mg)
155,000
biji tablet
Argenta Limited,
New Zealand
13.
Galliprant (100mg)
155,000
biji tablet
Argenta Limited,
New Zealand
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
5
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 Elanco 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 exporter as specified in the Schedule;
(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.
6
Jadual
Exempted Products
Product Name
Quantity
Exporter
1.
Milbemax (4/10mg)
film coated tablets for small cats and kittens
1,355,000 tablets
Elanco, France
2.
Milbemax (16/40mg)
film coated tablets for small cats and kittens
1,355,000 tablets
Elanco, France
3.
Onsior (5mg) for dogs
2,310,000 tablets
Elanco, France
4.
Onsior (10mg) for dogs
1,750,000 tablets
Elanco, France
5.
Onsior (20mg) for dogs
1,750,000 tablets
Elanco, France
6.
Onsior (40mg) for dogs
1,165,000 tablets
Elanco, France
7.
Onsior (6mg) for cats
6,725,000 tablets
Elanco, France
8.
Onsior (20mg/ml)
solution for injection for cats and dogs
70,000 vials
Bela-Pharm
GmbH & Co. KG,
Germany
9.
Fortekor Plus (1.25mg/2.5mg)
for dogs
1,130,000 tablets
Lek
Pharmaceuticals,
Slovenia
7
10.
Fortekor Plus (5mg/10mg)
for dogs
1,340,000 tablets
Lek
Pharmaceuticals,
Slovenia
11.
Galliprant (20mg)
208,000 tablets
Argenta Limited,
New Zealand
12.
Galliprant (60mg)
155,000 tablets
Argenta Limited,
New Zealand
13.
Galliprant (100mg)
155,000 tablets
Argenta Limited,
New Zealand
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) 105 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.