Is PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31 still in force?

Yes — PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31 is currently in force.

How many schedules does PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31 have?

PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31 contains 2 schedules.

/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:

(a)

keluaran itu hendaklah diimport hanya daripada pengeksport yang dinyatakan dalam Jadual;

(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.

Jadual

JADUAL

Keluaran Yang Dikecualikan

Nama Keluaran

Kuantiti

Pengeksport

Milbemax (4/10mg)

tablet bersalut nipis untuk kucing saiz kecil dan anak kucing

1,355,000

biji tablet

Elanco, Perancis

Milbemax (16/40mg)

tablet bersalut nipis untuk kucing saiz kecil dan anak kucing

1,355,000

biji tablet

Elanco, Perancis

Onsior (5mg) untuk anjing

2,310,000

biji tablet

Elanco, Perancis

Onsior (10mg) untuk anjing

1,750,000

biji tablet

Elanco, Perancis

Onsior (20mg) untuk anjing

1,750,000

biji tablet

Elanco, Perancis

Onsior (40mg) untuk anjing

1,165,000

biji tablet

Elanco, Perancis

Onsior (6mg) untuk kucing

6,725,000

biji tablet

Elanco, Perancis

Onsior (20mg/ml)

larutan bagi suntikan untuk kucing dan anjing

70,000 vial

Bela-Pharm

GmbH & Co. KG,

Jerman

Fortekor Plus (1.25mg/2.5mg)

untuk anjing

1,130,000

biji tablet

Lek

Pharmaceuticals,

Slovenia

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

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.

Jadual

Exempted Products

Product Name

Quantity

Exporter

Milbemax (4/10mg)

film coated tablets for small cats and kittens

1,355,000 tablets

Elanco, France

Milbemax (16/40mg)

film coated tablets for small cats and kittens

1,355,000 tablets

Elanco, France

Onsior (5mg) for dogs

2,310,000 tablets

Elanco, France

Onsior (10mg) for dogs

1,750,000 tablets

Elanco, France

Onsior (20mg) for dogs

1,750,000 tablets

Elanco, France

Onsior (40mg) for dogs

1,165,000 tablets

Elanco, France

Onsior (6mg) for cats

6,725,000 tablets

Elanco, France

Onsior (20mg/ml)

solution for injection for cats and dogs

70,000 vials

Bela-Pharm

GmbH & Co. KG,

Germany

Fortekor Plus (1.25mg/2.5mg)

for dogs

1,130,000 tablets

Lek

Pharmaceuticals,

Slovenia

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.