Many of us in this lifetime have bought and taken medicines. What is the probability that some of the medicines that we have been using is not registered with the Ministry of Health of Malaysia? The Control of Drugs and Cosmetics Regulations 1984 require all products imported, manufactured or sold to be registered with the Drug Control Authority (DCA). Any individual who contravenes this Regulations commits an offence and can be fined up to a maximum of RM 25,000.00 or a jail sentence for a term not exceeding 3 years or both for the first offence. For the second or subsequent offences the fine is not exceeding RM 50,000.00 or jail sentence for a term not exceeding five years or both. A company found guilty can be fined up to RM 50,000 for the first offence and up to a maximum of RM 100,000.00 for the second or subsequent offences.
Under this Regulations DCA has been established as the executive body to regulate product registration in Malaysia. The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia. Registered producs have been evaluated and tested for its efficacy, safety and quality. A registration number will be given when a product is registered with DCA. The registration number is specific to the product registered with the name, identity, composition, characteristics, origin (manufacturer) and marketing authorization holder as specified in the registration documents. It may not be used for any other product. Every registered product must have their registration number printed on its label or package. A security label (hologram Meditag®) is affixed to a registered product so that patient and enforcement officers can identify genuine products. The security label is only one of the many means that is used by the ministry to complement its enforcement activities to ensure public safety. The requirement for affixation of this security device to product label is only applicable to pharmaceutical product including health supplement and traditional product.
Registration number can be identified as a set of numbers with the alphabets “MAL” in front, followed by eight digits of number and ended with one or more alphabets. Registration of product in Malaysia has been divided into 3 categories. Each category of product can be identified by the first alphabet after the eight digits.
1) Alphabet “A” - for product containing scheduled poison as defined in the Poisons Act 1952
2) Alphabet “X” - for product not containing scheduled poison as defined in Poisons Act 1952
3) Alphabet “T” - for traditional product
Other alphabets used include C, E, R, S & V which is usually printed after the three main alphabet A, X, and T .
Monitoring of the quality of registered product in the market is carried out continuously by the Authority. Sample of products registered by the DCA may be taken and tested for compliance with official or pharmacopoeia standard or specifications. If the sample fails the test the market authorization holder will be issued a directive to recall of the product. The marketing authorization holder also is required to identify the source or cause of quality defect and action to be taken to improve quality. The registration of any product may be rejected, cancelled or suspended by the DCA if there are major deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration.
Public is advised to report any adverse or side effect experienced due to the product consumed or used to the authority. Such reporty will be discussed by MADRAC (Malaysian Adverse Drug Reaction Committee) for further action.
MOH urged the public to stop using unregistered products. Unregistered products have not been tested for its safety, quality and efficacy and thus pose a treat to the public health. It also might be adulterated or contaminated with heavy metals or banned substances. The authenticity of the MAL number can be verified through the website, http://www.bpfk.gov.my/.
© Sabah State Pharmacy Enforcement Branch
Under this Regulations DCA has been established as the executive body to regulate product registration in Malaysia. The main task of this Authority is to ensure the safety, quality and efficacy of pharmaceuticals, health and personal care products that are marketed in Malaysia. Registered producs have been evaluated and tested for its efficacy, safety and quality. A registration number will be given when a product is registered with DCA. The registration number is specific to the product registered with the name, identity, composition, characteristics, origin (manufacturer) and marketing authorization holder as specified in the registration documents. It may not be used for any other product. Every registered product must have their registration number printed on its label or package. A security label (hologram Meditag®) is affixed to a registered product so that patient and enforcement officers can identify genuine products. The security label is only one of the many means that is used by the ministry to complement its enforcement activities to ensure public safety. The requirement for affixation of this security device to product label is only applicable to pharmaceutical product including health supplement and traditional product.
Registration number can be identified as a set of numbers with the alphabets “MAL” in front, followed by eight digits of number and ended with one or more alphabets. Registration of product in Malaysia has been divided into 3 categories. Each category of product can be identified by the first alphabet after the eight digits.
1) Alphabet “A” - for product containing scheduled poison as defined in the Poisons Act 1952
2) Alphabet “X” - for product not containing scheduled poison as defined in Poisons Act 1952
3) Alphabet “T” - for traditional product
Other alphabets used include C, E, R, S & V which is usually printed after the three main alphabet A, X, and T .
Monitoring of the quality of registered product in the market is carried out continuously by the Authority. Sample of products registered by the DCA may be taken and tested for compliance with official or pharmacopoeia standard or specifications. If the sample fails the test the market authorization holder will be issued a directive to recall of the product. The marketing authorization holder also is required to identify the source or cause of quality defect and action to be taken to improve quality. The registration of any product may be rejected, cancelled or suspended by the DCA if there are major deficiencies in safety, quality or efficacy of the product or failure to comply with conditions of registration.
Public is advised to report any adverse or side effect experienced due to the product consumed or used to the authority. Such reporty will be discussed by MADRAC (Malaysian Adverse Drug Reaction Committee) for further action.
MOH urged the public to stop using unregistered products. Unregistered products have not been tested for its safety, quality and efficacy and thus pose a treat to the public health. It also might be adulterated or contaminated with heavy metals or banned substances. The authenticity of the MAL number can be verified through the website, http://www.bpfk.gov.my/.
© Sabah State Pharmacy Enforcement Branch
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2 comments:
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