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/2019/104

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) 104 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 Zoetis 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.

P.U. (B) 104 3

Jadual

JADUAL

Keluaran Yang Dikecualikan

Nama Keluaran

Kuantiti

Pengeksport

Revolution Plus (15mg/2.5mg)

66,000 tiub

Zoetis Inc.,

Amerika Syarikat

Revolution Plus (30mg/5mg)

195,000 tiub

Zoetis Inc.,

Amerika Syarikat

Revolution Plus (60mg/10mg)

12,000 tiub

Zoetis Inc.,

Amerika Syarikat

Simparica Tablet Kunyah

(5mg)

12,000 biji tablet

Zoetis Inc.,

Amerika Syarikat

Simparica Tablet Kunyah

(10mg)

33,000 biji tablet

Zoetis Inc.,

Amerika Syarikat

Simparica Tablet Kunyah

(20mg)

57,000 biji tablet

Zoetis Inc.,

Amerika Syarikat

Simparica Tablet Kunyah

(40mg)

45,000 biji tablet

Zoetis Inc.,

Amerika Syarikat

Simparica Tablet Kunyah

(80mg)

57,000 biji tablet

Zoetis Inc.,

Amerika Syarikat

Simparica

Tablet

Kunyah

(120mg)

12,000 biji tablet

Zoetis Inc.,

Amerika Syarikat

P.U. (B) 104 4

10.

Cytopoint (10mg)

larutan bagi suntikan untuk anjing

11,000 vial

Zoetis Inc.,

Belgium

11.

Cytopoint (20mg)

larutan bagi suntikan untuk anjing

17,000 vial

Zoetis Inc.,

Belgium

12.

Cytopoint (30mg)

larutan bagi suntikan untuk anjing

19,000 vial

Zoetis Inc.,

Belgium

13.

Cytopoint (40mg)

larutan bagi suntikan untuk anjing

4,000 vial

Zoetis Inc.,

Belgium

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

P.U. (B) 104 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

Zoetis 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.

P.U. (B) 104 6

Jadual

Exempted Products

Product Name

Quantity

Exporter 1.

Revolution Plus (15mg/2.5mg)

66,000 tubes

Zoetis Inc.,

United States of America 2.

Revolution Plus (30mg/5mg)

195,000 tubes

Zoetis Inc.,

United States of America 3.

Revolution Plus (60mg/10mg)

12,000 tubes

Zoetis Inc.,

United States of America 4.

Simparica Chewables (5mg)

12,000 tablets

Zoetis Inc.,

United States of America 5.

Simparica Chewables (10mg)

33,000 tablets

Zoetis Inc.,

United States of America 6.

Simparica Chewables (20mg)

57,000 tablets

Zoetis Inc.,

United States of America 7.

Simparica Chewables (40mg)

45,000 tablets

Zoetis Inc.,

United States of America 8.

Simparica Chewables (80mg)

57,000 tablets

Zoetis Inc.,

United States of America

P.U. (B) 104 7

Simparica Chewables (120mg)

12,000 tablets

Zoetis Inc.,

United States of America

10.

Cytopoint (10mg)

solution for injection for dogs

11,000 vials

Zoetis Inc.,

Belgium

11.

Cytopoint (20mg)

solution for injection for dogs

17,000 vials

Zoetis Inc.,

Belgium

12.

Cytopoint (30mg)

solution for injection for dogs

19,000 vials

Zoetis Inc.,

Belgium

13.

Cytopoint (40mg)

solution for injection for dogs

4,000 vials

Zoetis Inc.,

Belgium

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) 104 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.