/akn/my/act/pub/2019/242

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) 242 2019, currently marked in force and first recorded in 2019.

Opening note

Preamble

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  1. 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 Bayer Co. (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 15 Mei 2019 hingga 31 Disember 2022 tertakluk kepada syarat yang berikut:

(a)

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

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(b)

keluaran itu hendaklah dijual, dibekalkan dan diimport tidak melebihi kuantiti yang dinyatakan dalam Jadual;

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(c)

keluaran itu hendaklah diimport hanya bagi maksud dan kegunaan doktor veterinar berdaftar dan dibekalkan dan dijual hanya kepada doktor veterinar berdaftar;

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(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

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(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) 242 3

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Jadual

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JADUAL

Keluaran Yang Dikecualikan

Nama Keluaran

Kuantiti

Pengilang

Veraflox 25mg/ml (15ml)

suspensi mulut untuk kucing

4,000 botol

KVP Pharma +

Veterinar Produkte

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) 242 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

Bayer Co. (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 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) 242 5

Jadual

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Exempted Products

Product Name

Quantity

Manufacturer

Veraflox 25mg/ml (15ml) oral suspension for cats

4,000 bottles

KVP Pharma +

Veterinar Produkte

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) 242 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.
PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31 (2019, No. 242)