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/2017/413

PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31

The full official text, structured for quick navigation. Copy any provision or jump straight to a section.

Open source PDF

Type: P.U. (B)
Status: In force
Enacted: 2017
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) 413 2017, currently marked in force and first recorded in 2017.

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 Rhone Ma 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 Mei 2017 hingga 31 Disember 2020 tertakluk kepada syarat yang berikut:

(a)

keluaran itu hendaklah diimport hanya daripada syarikat Merial, Lyon,

France;

(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 anggota Persatuan Doktor Veterinar Haiwan Kesayangan Malaysia dan dibekalkan dan dijual semata-mata kepada anggota Persatuan Doktor

Veterinar Haiwan Kesayangan Malaysia;

(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.

P.U. (B) 413 3

Jadual

JADUAL

Keluaran Yang Dikecualikan

Nama Keluaran

Kuantiti

NexGard® (11mg)

54,000 biji tablet

NexGard® (28mg)

126,000 biji tablet

NexGard® (68mg)

144,000 biji tablet

NexGard® (136mg)

243,000 biji tablet

Broadline® (0.3ml)

Spot-on Solution untuk kucing

81,000 unit 6.

Broadline® (0.9ml)

Spot-on Solution untuk kucing

121,500 unit 7.

Biodyl®(50ml)

21,000 botol

Bertarikh 27 Julai 2017

[KKM.600-11/2/22; PN(PU2)269A/IV]

DATUK SERI DR. S.SUBRAMANIAM

Menteri Kesihatan

P.U. (B) 413 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 Rhone Ma 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 May 2017

to 31 December 2020 subject to the following conditions:

(a)

the products shall be imported only from the company of Merial, Lyon,

France;

(b)

the products shall be sold, supplied and imported not exceeding the quantity as specified in the Schedule;

(c)

the products shall be imported only for the purposes and use of the members of the Malaysian Small Animal Veterinary Association and supplied and sold solely to the members of the Malaysian Small Animal

Veterinary Association;

(d)

a copy of 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) 413 5

Jadual

Exempted Products

Product Name

Quantity

NexGard® (11mg)

54,000 tablets

NexGard® (28mg)

126,000 tablets

NexGard® (68mg)

144,000 tablets

NexGard® (136mg)

243,000 tablets

Broadline® (0.3ml)

Spot-on Solution for cats

81,000 units 6.

Broadline® (0.9ml)

Spot-on Solution for cats

121,500 units 7.

Biodyl®(50ml)

21,000 bottles

Dated 27 July 2017

[KKM.600-11/2/22; PN(PU2)269A/IV]

DATUK SERI DR. S.SUBRAMANIAM

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) 413 2017, currently marked in force and first recorded in 2017.
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 2017.
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.