Bandar Seri Begawan - The Ministry of Health (MoH) has announced that it is mandatory for all medicinal products in the country to be registered in accordance with the Medicines Order 2007 and its regulations. Failure to comply may result in prosecution under strict laws.
In a press release to inform the public and relevant stakeholders - including pharmaceutical importers, wholesalers and retailers - it said the mandatory requirement has been in effect since July 1, 2012 in line with the Medicines Order 2007 and its regulations, namely, Medicines (Licensing, Standard Provisions and Fees) Regulations, 2010 and Medicines (Labelling) Regulations, 2010.
According to Section 10 (1) of the Medicines Order 2007, all medicinal products must be registered with the MoH before being manufactured, sold, supplied in or imported into Brunei Darussalam.
Additionally, the person must have appropriate licences to conduct the mentioned activities, except for retailers selling or supplying medicinal products on general sale.
Types of licence granted to conduct the mentioned activities in accordance with Regulation 2 of the Medicines (Licensing, Standard Provisions and Fees) Regulations 2010 are as follows:
- Product Licence issued upon registration of medicinal products authorising the product to be marketed in Brunei Darussalam;
- Import Licence authorises the licensee to import, store and sell by wholesale or supply registered medicinal products from the specified business premise;
- Wholesale Dealer's Licence authorises the licensee to sell by wholesale or supply registered medicinal products from the specified business premise; and
- Manufacturer's Licence authorises the licensee to manufacture from specified premise and to sell by wholesale or supply registered medicinal products.
In line with the enforcement of the above requirements, a dispensed medicinal product must be labelled appropriately in accordance with Regulation 3 of the Medicines (Labelling) Regulations 2010. The immediate container of the dispensed medicinal product must be labelled to show the following particulars:
- The name of the person to whom the medicinal product is to be administered;
- The name and address of the medical or dental practice, registered pharmacy or hospital or any other institution where the medicinal product is supplied or dispensed and any other identification number or mark;
- The date upon which the medicinal product is dispensed;
- The direction for use of the medicinal product;
- The name of the medicinal product being either in the appropriate non-proprietary name or the proprietary designation;
- Where the appropriate non-proprietary name is labelled, the appropriate quantitative particulars of the active ingredients of the medicinal product.
The press release further states that contravention or failure to comply with the licensing and/or labelling requirements are offences under the Medicines Order 2007, Medicines (Licensing, Standard Provisions and Fees) Regulations 2010 and Medicines (Labelling) Regulations 2010, which, if found guilty, carries a fine not exceeding B$5,000, imprisonment for a term not exceeding two years, or both.
The ministry would also like to advise all relevant agencies that, effective July 1, 2012, any medicinal product not registered with the MoH will not be allowed to be imported and marketed in Brunei. This is to ensure that all medicinal products that are marketed in Brunei are safe, efficacious and of quality.
For further information, the public can visit the Drug Registration Unit, Drug Administration Section, Block 2G:8:03, 8th Floor, Ong Sum Ping Condominium, Bandar Seri Begawan or dial 2230001 or 2230041.--Courtesy of Borneo Bulletin