(a)
keluaran itu hendaklah diimport hanya daripada pengilang yang dinyatakan dalam Jadual;
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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
keluaran itu hendaklah diimport hanya daripada pengilang yang dinyatakan dalam Jadual;
keluaran itu hendaklah dijual, dibekalkan dan diimport tidak melebihi kuantiti yang dinyatakan dalam Jadual;
keluaran itu hendaklah diimport hanya bagi maksud dan kegunaan doktor veterinar berdaftar dan dibekalkan dan dijual hanya kepada doktor veterinar berdaftar;
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
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
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
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