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/2019/237

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) 237 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 Intervet (M) 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:

(a)

keluaran itu hendaklah diimport hanya daripada pengilang 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 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) 237 3

Jadual

JADUAL

Keluaran Yang Dikecualikan

Nama Keluaran

Kuantiti

Pengilang

Bravecto 112.5mg tablet kunyah untuk anjing saiz sangat kecil

(2-4.5kg)

60,000 biji tablet

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 250mg tablet kunyah untuk anjing saiz kecil (melebihi 4.5–10kg)

60,000 biji tablet

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 500mg tablet kunyah untuk anjing saiz sederhana

(melebihi 10–20kg)

195,000 biji tablet

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 1000mg tablet kunyah untuk anjing saiz besar

(melebihi 20-40kg)

195,000 biji tablet

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 1400mg tablet kunyah untuk anjing saiz sangat besar

(melebihi 40-56kg)

195,000 biji tablet

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 112.5mg Spot-on

Solution untuk anjing saiz sangat kecil (2-4.5kg)

60,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

Bravecto 250mg Spot-on

Solution untuk anjing saiz kecil

(melebihi 4.5-10kg)

60,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

Bravecto 500mg Spot-on

Solution untuk anjing saiz sederhana (melebihi 10-20kg)

195,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

P.U. (B) 237 4

Bravecto 1000mg Spot-on

Solution untuk anjing saiz besar

(melebihi 20-40kg)

195,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

10.

Bravecto 1400mg Spot-on

Solution untuk anjing saiz sangat besar (melebihi 40-56kg)

195,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

11.

Bravecto 112.5mg Spot-on

Solution untuk kucing saiz kecil

(1.2-2.8kg)

145,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

12.

Bravecto 250mg Spot-on

Solution untuk kucing saiz sederhana (melebihi 2.8-6.25kg)

300,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

13.

Bravecto 500mg Spot-on

Solution untuk kucing saiz besar

(melebihi 6.25-12.5kg)

300,000 pipet

Patheon

Manufacturing

Services LLC,

Amerika Syarikat

14.

Posatex, titis suspensi telinga untuk anjing

20,000 botol

Vet Pharma

Friesoythe GmbH,

Jerman

15.

Imizol

30,000 vial

Vet Pharma

Friesoythe GmbH,

Jerman

16.

Dexafort

25,000 vial

Vet Pharma

Friesoythe GmbH,

Jerman

17.

Vivitonin 50mg tablet bersalut nipis untuk anjing

2,000 biji tablet

Intervet GesmbH

(MSD Animal

Health), Austria

18.

Vivitonin 100mg tablet bersalut nipis untuk anjing

2,000 biji tablet

Intervet GesmbH

(MSD Animal

Health), Austria

P.U. (B) 237 5

19.

Dolorex 10mg/ml larutan bagi suntikan untuk kuda, anjing dan kucing

2,000 vial

Intervet

International

GmbH,

Jerman

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) 237 6

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

Intervet (M) 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) 237 7

Jadual

Exempted Products

Product Name

Quantity

Manufacturer

Bravecto 112.5mg chewable tablets for very small dogs

(2-4.5kg)

60,000 tablets

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 250mg chewable tablets for small dogs (more than 4.5-10kg)

60,000 tablets

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 500mg chewable tablets for medium-sized dogs

(more than 10-20kg)

195,000 tablets

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 1000mg chewable tablets for large dogs (more than 20-40kg)

195,000 tablets

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 1400mg chewable tablets for very large dogs

(more than 40-56kg)

195,000 tablets

Intervet GesmbH

(MSD Animal

Health),

Austria

Bravecto 112.5mg Spot-on

Solution for very small dogs

(2-4.5kg)

60,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

Bravecto 250mg Spot-on

Solution for small dogs (more than 4.5-10kg)

60,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

P.U. (B) 237 8

Bravecto 500mg Spot-on

Solution for medium-sized dogs

(more than 10-20kg)

195,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

Bravecto 1000mg Spot-on

Solution for large dogs (more than 20-40kg)

195,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

10.

Bravecto 1400mg Spot-on

Solution for very large dogs

(more than 40-56kg)

195,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

11.

Bravecto 112.5mg Spot-on

Solution for small cats (1.2-

2.8kg)

145,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

12.

Bravecto 250mg Spot-on

Solution for medium-sized cats

(more than 2.8-6.25kg)

300,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

13.

Bravecto 500mg Spot-on

Solution for large cats (more than 6.25-12.5kg)

300,000 pipettes

Patheon

Manufacturing

Services LLC,

United States of

America

14.

Posatex, ear suspension drops for dogs 20,000 bottles

Vet Pharma

Friesoythe GmbH,

Germany

15.

Imizol

30,000 vials

Vet Pharma

Friesoythe GmbH,

Germany

16.

Dexafort

25,000 vials

Vet Pharma

Friesoythe GmbH,

Germany

P.U. (B) 237 9

17.

Vivitonin 50mg film-coated tablets for dogs

2,000 tablets

Intervet GesmbH

(MSD Animal

Health), Austria

18.

Vivitonin 100mg film-coated tablets for dogs

2,000 tablets

Intervet GesmbH

(MSD Animal

Health), Austria 19.

Dolorex 10mg/ml solution for injection for horse, dog and cat 2,000 vials

Intervet

International GmbH,

Germany

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) 237 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.