(a)
keluaran itu hendaklah diimport hanya daripada pengilang yang dinyatakan dalam Jadual;
/akn/my/act/pub/2019/241
PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31
The full official text, structured for quick navigation. Copy any provision or jump straight to a section.
- 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) 241 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 My Vet Care Sdn. Bhd. daripada pemakaian subperaturan 7(1) berhubung dengan penjualan, pembekalan, pengimportan dan pemilikan keluaran veterinar sebagaimana yang diperihalkan dalam Jadual berkuat kuasa mulai 15 Mei 2019 hingga 31 Disember 2022 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 hanya kepada doktor veterinar berdaftar;
(d)
suatu salinan borang import Kastam bagi tiap-tiap pengimportan keluaran itu hendaklah dihantar dalam masa tiga puluh hari dari tarikh pengimportan kepada
Pengarah
Kanan
Perkhidmatan
Farmasi,
Kementerian Kesihatan; 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) 241 3
Jadual
JADUAL
Keluaran Yang Dikecualikan
Nama Keluaran
Kuantiti
Pengilang
1.
Canaural titis suspensi telinga untuk anjing dan kucing
(1 x 15ml)
80,000 botol
Dales
Pharmaceuticals
Limited, United
Kingdom
2.
Canaural titis suspensi telinga untuk anjing dan kucing
(10 x 15ml)
80,000 botol
Dales
Pharmaceuticals
Limited, United
Kingdom
3.
Canaural titis suspensi telinga untuk anjing dan kucing
(1 x 25ml)
80,000 botol
Dales
Pharmaceuticals
Limited, United
Kingdom
4.
Canaural titis suspensi telinga untuk anjing dan kucing
(1 x 100ml)
80,000 botol
Dales
Pharmaceuticals
Limited, United
Kingdom
5.
Framixin antibiotik salap telinga dan mata 5g
80,000 bekas
Dechra Veterinary
Products Pty. Ltd.,
Australia
6.
Framixin H antibiotik anti-radang salap telinga dan mata 5g
80,000 bekas
Dechra Veterinary
Products Pty. Ltd.,
Australia
7.
Vetropolycin 3.5g
80,000 tiub
Altaire
Pharmaceuticals
Inc., Amerika
Syarikat
8.
Vetropolycin HC 3.5g
80,000 tiub
Altaire
Pharmaceuticals
Inc., Amerika
Syarikat
P.U. (B) 241 4
9.
Prevomax 10mg/ml (10ml)
larutan bagi suntikan untuk anjing dan kucing 20,000 vial
Produlab Pharma
B.V., Belanda
10.
Prevomax 10mg/ml (20ml)
larutan bagi suntikan untuk anjing dan kucing
20,000 vial
Produlab Pharma
B.V., Belanda
11.
Prevomax 10mg/ml (25ml)
larutan bagi suntikan untuk anjing dan kucing
20,000 vial
Produlab Pharma
B.V., Belanda
12.
Prevomax 10mg/ml (50ml)
larutan bagi suntikan untuk anjing dan kucing
20,000 vial
Produlab Pharma
B.V., Belanda
13.
Phenoleptil 12.5mg tablet untuk anjing
160,000 biji tablet
Produlab Pharma
B.V., Belanda
14.
Phenoleptil 25mg tablet untuk anjing
160,000 biji tablet
Produlab Pharma
B.V., Belanda
15.
Phenoleptil 50mg tablet untuk anjing
160,000 biji tablet
Produlab Pharma
B.V., Belanda
16.
Phenoleptil 100mg tablet untuk anjing
160,000 biji tablet
Produlab Pharma
B.V., Belanda
17.
Isoflurin 1000mg/g (250ml)
wap sedutan, cecair
12,000 botol
Chemical Iberica PV,
Sepanyol
Bertarikh 25 April 2019
[KKM.R.600-1/3/72 Jld.2(8); PN(PU2)269A/VI]
DATUK SERI DR. DZULKEFLY BIN AHMAD
Menteri Kesihatan
P.U. (B) 241 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 My Vet Care 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 15 May 2019 to 31 December 2022 subject to the following conditions:
(a)
the products shall be imported only from the manufacturer 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 only 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) 241 6
Jadual
Exempted Products
Product Name
Quantity
Manufacturer
1.
Canaural ear suspension drops for dogs and cats (1 x 15ml)
80,000 bottles
Dales
Pharmaceuticals
Limited, United
Kingdom
2.
Canaural ear suspension drops for dogs and cats (10 x 15ml)
80,000 bottles
Dales
Pharmaceuticals
Limited, United
Kingdom
3.
Canaural ear suspension drops for dogs and cats (1 x 25ml)
80,000 bottles
Dales
Pharmaceuticals
Limited, United
Kingdom
4.
Canaural ear suspension drops for dogs and cats (1 x 100ml)
80,000 bottles
Dales
Pharmaceuticals
Limited, United
Kingdom
5.
Framixin ear and eye ointment antibiotic 5g
80,000 containers
Dechra Veterinary
Products Pty. Ltd.,
Australia
6.
Framixin H ear and eye ointment antibiotic anti-inflammatory 5g
80,000 containers
Dechra Veterinary
Products Pty. Ltd.,
Australia
7.
Vetropolycin 3.5g
80,000 tubes
Altaire
Pharmaceuticals
Inc., United States of
America
8.
Vetropolycin HC 3.5g
80,000 tubes
Altaire
Pharmaceuticals
Inc., United States of
America
P.U. (B) 241 7
9.
Prevomax 10mg/ml (10ml)
solution for injection for dogs and cats 20,000 vials
Produlab Pharma
Netherlands
10.
Prevomax 10mg/ml (20ml)
solution for injection for dogs and cats
20,000 vials
Produlab Pharma
Netherlands
11.
Prevomax 10mg/ml (25ml)
solution for injection for dogs and cats
20,000 vials
Produlab Pharma
Netherlands
12.
Prevomax 10mg/ml (50ml)
solution for injection for dogs and cats
20,000 vials
Produlab Pharma
Netherlands
13.
Phenoleptil 12.5mg tablets for dogs
160,000 tablets
Produlab Pharma
Netherlands
14.
Phenoleptil 25mg tablets for dogs
160,000 tablets
Produlab Pharma
Netherlands
15.
Phenoleptil 50mg tablets for dogs
160,000 tablets
Produlab Pharma
Netherlands
16.
Phenoleptil 100mg tablets for dogs
160,000 tablets
Produlab Pharma
Netherlands
17.
Isoflurin 1000mg/g (250ml)
inhalation vapour, liquid
12,000 bottles
Chemical Iberica PV,
Spain
Dated 25 April 2019
[KKM.R.600-1/3/72 Jld.2(8); PN(PU2)269A/VI]
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) 241 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.