P.U. (A)In force

Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013

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Enacted: 2013
Sections: 14

Front matterCover and publication detailsOpen

P.U. (A) 105

WARTA KERAJAAN PERSEKUTUAN

FEDERAL GOVERNMENT

GAZETTE

PERATURAN-PERATURAN KAWALAN DADAH DAN

KOSMETIK (PINDAAN) 2013

CONTROL OF DRUGS AND COSMETICS (AMENDMENT)

REGULATIONS 2013

DISIARKAN OLEH/

JABATAN PEGUAM NEGARA/

ATTORNEY GENERAL’S CHAMBERS

P.U. (A) 105 2

AKTA JUALAN DADAH 1952

PERATURAN-PERATURAN KAWALAN DADAH DAN KOSMETIK (PINDAAN) 2013

Opening note

Preamble

PADA menjalankan kuasa yang diberikan oleh subseksyen 26(1) Akta Jualan Dadah 1952 [Akta 368], Menteri membuat peraturan-peraturan yang berikut: Nama dan permulaan kuat kuasa

Seksyen 1

(1)

Peraturan-peraturan ini bolehlah dinamakan Peraturan-Peraturan

Kawalan Dadah dan Kosmetik (Pindaan) 2013.

(2)

Peraturan-Peraturan ini mula berkuat kuasa pada 28 Mac 2013.

Seksyen 2

Pindaan subperaturan 7(1A)

Peraturan-Peraturan Kawalan Dadah dan Kosmetik 1984 [P.U. (A) 223/1984], yang disebut “Peraturan-Peraturan ibu” dalam Peraturan-Peraturan ini, dipinda dalam subperaturan 7(1A) dengan memasukkan selepas perenggan (g), perenggan berikut:

“(h)

yang mengandungi bahan cemaran logam melainkan jika terjadi secara semula jadi, yang terdapat di dalam mana-mana ubat tradisional sebagaimana yang dinyatakan dalam ruang (1) Daftar I kepada Jadual, dalam kadar yang tidak melebihi kadar maksimum yang dibenarkan yang dinyatakan bersetentangan dengan bahan itu dalam ruang (2) Daftar itu.”.

Seksyen 3

Peraturan baru 7A

Peraturan-Peraturan ibu dipinda dengan memasukkan selepas peraturan 7, peraturan yang berikut:

Seksyen 7A

Tiada seorang pun boleh mengilang, menjual, membekal, mengimport, memiliki atau memberi apa-apa ubat tradisional yang mengandungi apa-apa bahan yang dinyatakan dalam Daftar II kepada Jadual.”.

“Larangan berkaitan ubat tradisional

P.U. (A) 105 3

Pindaan Jadual 4.

Jadual kepada Peraturan-Peraturan ibu dipinda dengan memasukkan selepas

Borang 5, daftar yang berikut:

“DAFTAR I

(Peraturan 7)

KADAR MAKSIMUM BAHAN CEMARAN LOGAM YANG TERJADI SECARA SEMULA JADI

YANG DIBENARKAN DI DALAM UBAT TRADISIONAL

(1)

Bahan

(Cemaran Logam)

(2)

Kadar maksimum yang dibenarkan

Arsenik 5.0 mg/kg atau 5.0 mg/liter atau 5.0 ppm

Kadmium 0.3 mg/kg atau 0.3 mg/liter atau 0.3 ppm

Plumbum 10.0mg/kg atau 10.0 mg/liter atau 10.0 ppm

Merkuri 0.5 mg/kg atau 0.5 mg/liter atau 0.5 ppm

DAFTAR II

(Peraturan 7A)

BAHAN-BAHAN YANG DILARANG DI DALAM UBAT TRADISIONAL

Bahan-bahan berikut adalah dilarang di dalam ubat tradisional:

Seksyen 1

Kafeina

Seksyen 2

Nikotinamida

Seksyen 3

Parasetamol

Seksyen 4

Racun mengikut pengertian Akta Racun 1952 [Akta 366]”.

P.U. (A) 105 4

Dibuat 11 Mac 2013

[KK(R) 608(13/2)Bhg. ; PN(PU2)269A/IV]

DATO’ SRI LIOW TIONG LAI

Menteri Kesihatan

P.U. (A) 105 5

SALE OF DRUGS ACT 1952

CONTROL OF DRUGS AND COSMETICS (AMENDMENT) REGULATIONS 2013

Opening note

Preamble

IN exercise of the powers conferred by subsection 26(1) of the Sale of Drugs Act 1952 [Act 368], the Minister makes the following regulations: Citation and commencement 1.

(1)

These regulations may be cited as the Control of Drugs and

Cosmetics (Amendment) Regulations 2013.

(2)

These Regulations come into operation on 28 March 2013.

Amendment of subregulation 7(1A)

Seksyen 2

The Control of Drugs and Cosmetics Regulations 1984 [P.U. (A) 223/1984], which are referred to as the “principal Regulations” in these Regulations, are amended in subregulation 7(1A) by inserting after paragraph (g) the following paragraph:

“(h)

which contains any metal contaminant unless naturally occurs, which contained in any traditional medicine as specified in column (1) of Table I to the

Schedule in a proportion not greater than the maximum permitted proportion specified opposite the substance in column (2) of the Table.”.

New regulation 3.

The principal Regulations are amended by inserting after regulation 7, the following regulation:

Seksyen 7A

No person shall manufacture, sell, supply, import, possess or administer any traditional medicine which contains any substance as set out in Table II to the Schedule.”.

“Prohibition regarding traditional medicine

P.U. (A) 105 6

Amendment of Schedule 4.

The Schedule of the principal Regulations is amended by inserting after Form 5, the following tables:

“TABLE I

(Regulation 7)

MAXIMUM PERMITTED PROPORTION OF NATURALLY OCCURRING METAL

CONTAMINANT IN TRADITIONAL MEDICINE

(1)

Substance

(Metal Contaminant)

(2)

Maximum permitted proportion

Arsenic 5.0 mg/kg or 5.0 mg/litre or 5.0 ppm

Cadmium 0.3 mg/kg or 0.3 mg/litre or 0.3 ppm

Lead 10.0mg/kg or 10.0 mg/litre or 10.0 ppm

Mercury 0.5 mg/kg or 0.5 mg/litre or 0.5 ppm

TABLE II

(Regulation 7A)

PROHIBITED SUBSTANCES IN TRADITIONAL MEDICINE

The following substances are prohibited in traditional medicine:

Seksyen 1

Caffeine

Seksyen 2

Nicotinamide

Seksyen 3

Paracetamol

Seksyen 4

Poison within the meaning of the Poisons Act 1952 [Act 366]”.

Made 11 March 2013

[KK(R) 608(13/2)Bhg. ; PN(PU2)269A/IV]

DATO’ SRI LIOW TIONG LAI

Minister of Health

Common questions

What is Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013?: Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 is Malaysia P.U. (A), cited as P.U. (A) 105 2013, currently marked in force and first recorded in 2013.
Is Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 still in force?: Yes — Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 is currently in force.
When did Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 take effect?: Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 was first recorded in 2013.
How many sections does Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 have?: Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 contains 14 sections.
Where can I read the official version of Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013?: The official text of Peraturan-Peraturan Kawalan Dadah dan Kosmetik (Pindaan) 2013 is published at lom.agc.gov.my.

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