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.
Pindaan subperaturan 7(1A)
/akn/my/act/pua/2013/105
PERATURAN-PERATURAN KAWALAN DADAH DAN KOSMETIK (PINDAAN) 2013
The full official text, structured for quick navigation. Copy any provision or jump straight to a section.
- Type
- P.U. (A)
- Status
- In force
- Enacted
- 2013
- Sections
- 14
Quick answer
About this p.u. (a)
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.
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 2
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
(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
(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.