(a)
keluaran itu hendaklah diimport hanya daripada pengeksport yang dinyatakan dalam Jadual;
/akn/my/act/pub/2017/412
PEMBERITAHUAN PENGECUALIAN DI BAWAH PERATURAN 31
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- 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) 412 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 Eli Lilly (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:
(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.
3
Jadual
JADUAL
Keluaran Yang Dikecualikan
Nama Keluaran
Kuantiti
Pengeksport
1.
Atopica® (25mg)
135,000 biji kapsul
Catalent Germany Eberbach
GmbH Eberbach Germany
2.
Atopica® (50mg)
135,000 biji kapsul
Catalent Germany Eberbach
GmbH Eberbach Germany
3.
Capstar® (11.4mg)
54,000 biji tablet
Elanco France SAS
Huningue France
4.
Capstar® (57mg)
54,000 biji tablet
Elanco France SAS
Huningue France
5.
Interceptor® Spectrum
(bagi anjing saiz sangat kecil)
54,000 biji tablet
Ex-Lax Inc.
Humacao Puerto Rico
6.
Interceptor® Spectrum
(bagi anjing saiz kecil)
54,000 biji tablet
Ex-Lax Inc.
Humacao Puerto Rico
7.
Interceptor® Spectrum
(bagi anjing saiz sederhana)
54,000 biji tablet
Ex-Lax Inc.
Humacao Puerto Rico
8.
Interceptor® Spectrum
(bagi anjing saiz besar)
54,000 biji tablet
Ex-Lax Inc.
Humacao Puerto Rico
9.
Panoramis®
(bagi anjing 2.3-4.5kg)
36,000 biji tablet
AbbVie Inc.
North Chicago, Illinois, USA
10.
Panoramis®
(bagi anjing 4.6-9kg)
36,000 biji tablet
AbbVie Inc.
North Chicago, Illinois, USA
11.
Panoramis®
(bagi anjing 9.1-18kg)
36,000 biji tablet
AbbVie Inc.
North Chicago, Illinois, USA
12.
Panoramis®
(bagi anjing 18.1-27kg)
36,000 biji tablet
AbbVie Inc.
North Chicago, Illinois, USA
4
13.
Panoramis®
(bagi anjing 27.1-54kg)
36,000 biji tablet
AbbVie Inc.
North Chicago, Illinois, USA
Bertarikh 27 Julai 2017
[KKM.600-11/2/22; PN(PU2)269A/IV]
DATUK SERI DR. S.SUBRAMANIAM
Menteri Kesihatan
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 Eli Lilly (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 exporter as specified in the Schedule;
(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.
6
Jadual
Exempted Products
Product Name
Quantity
Exporter
1.
Atopica® (25mg)
135,000 capsules
Catalent Germany Eberbach
GmbH Eberbach Germany
2.
Atopica® (50mg)
135,000 capsules
Catalent Germany Eberbach
GmbH Eberbach Germany
3.
Capstar® (11.4mg)
54,000 tablets
Elanco France SAS
Huningue France
4.
Capstar® (57mg)
54,000 tablets
Elanco France SAS
Huningue France
5.
Interceptor® Spectrum
(for very small size dogs)
54,000 tablets
Ex-Lax Inc.
Humacao Puerto Rico
6.
Interceptor® Spectrum
(for small size dogs)
54,000 tablets
Ex-Lax Inc.
Humacao Puerto Rico
7.
Interceptor® Spectrum
(for medium size dogs)
54,000 tablets
Ex-Lax Inc.
Humacao Puerto Rico
8.
Interceptor® Spectrum
(for large size dogs)
54,000 tablets
Ex-Lax Inc.
Humacao Puerto Rico
9.
Panoramis®
(for dogs 2.3-4.5kg)
36,000 tablets
AbbVie Inc.
North Chicago, Illinois, USA
10.
Panoramis®
(for dogs 4.6-9kg)
36,000 tablets
AbbVie Inc.
North Chicago, Illinois, USA
11.
Panoramis®
(for dogs 9.1-18kg)
36,000 tablets
AbbVie Inc.
North Chicago, Illinois, USA
12.
Panoramis®
(for dogs 18.1-27kg)
36,000 tablets
AbbVie Inc.
North Chicago, Illinois, USA
13.
Panoramis®
(for dogs 27.1-54kg)
36,000 tablets
AbbVie Inc.
North Chicago, Illinois, USA
7
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) 412 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.