MoH monitoring continues to ensure medicines regulated

THE Department of Pharmaceutical Services, Ministry of Health (MoH) would like to refer to the letter ‘Are medicines prescribed from private clinics regulated’ by Sibling published in the Opinion page of the Weekend Bulletin on November 24.

We would like to thank the writer for the concern with regards to the regulation of medicines (pharmaceuticals/medicinal products).

The MoH through the Department of Pharmaceutical Services has the responsibility of regulating and controlling the manufacture, sell, supply or import of any medicinal products in Brunei Darussalam in line with the Medicines Order, 2007 and its related regulations, Poison Act 1956 and other related legislation and guidelines.

With the commencement of the Medicines Order, 2007 and its related regulations, registration of medicinal products is mandatory since July 1, 2012 before they can be marketed in Brunei Darussalam.

All medicinal products imported and marketed in the country must be registered and approved by the Brunei Darussalam Medicines Control Authority (BDMCA).

Every consignment of medicinal products imported into Brunei Darussalam (both for MoH and non-MoH facilities) must be declared through the Brunei Darussalam National Single Window (BDNSW) by the company importing the products.

The importers must also have a valid Import Licence, as well as a valid product licence/permit for the medicinal products to be imported.

These consignments will later be endorsed by the Compliance and Licensing Section, Department of Pharmaceutical Services.

Wholesalers dealing with medicinal products must also have a Wholesale Dealer’s Licence which will enable them to sell to other premises such as pharmacies which holds Poison Licences.

Both importers and wholesalers must abide to the standard provisions under the second and third schedule of the Medicines (Licensing, Standard Provisions and Fees Regulations), 2010 of the Medicines Order, 2007.

The Department of Pharmaceutical Services also conducts Post Marketing Surveillance to monitor the quality and safety of medicinal products marketed in the country.

This includes regular inspections to supermarkets, retail outlets, importers, wholesalers, medical halls, pharmacies, private clinics, expos, exhibitions, trade fairs and entry points.

Random sampling of medicinal products (as well as traditional medicines, health supplements and cosmetic products) in the market is carried out to ensure the product meets the specifications and have the approval or notification to the MoH.

Public cooperation to report any suspected products are encouraged where appropriate investigation and further action would be taken.

Healthcare professionals are also encouraged to report adverse events of suspected medicinal products which can assist in detecting substandard/ spurious/ falsely labelled/ falsified/ counterfeit (SSFFC) medical products.

Medicinal products sold without a licence or approval will be confiscated.

Compounding can be initiated by the authorities in line with Section 77 of the Medicines Order, 2007 by collecting from the person reasonably suspected of having committed the offence a sum not exceeding BND2,000.

We invite the public to contact us directly for queries or reports at the Compliance and Licensing Section at 2393298 (ext 208) or email to pharmacy.enforcement@moh.gov.bn or visit 1st floor, Department of Pharmaceutical Services’ Building, Kampong Madaras, Mukim Gadong ‘A’, Brunei Darussalam.

The MoH endeavours to continuously monitor all medicinal products in the market to ensure its quality, efficacy and safety for the population of Brunei Darussalam.

– Pengiran Anuar bin Pengiran Rambli

Head of Corporate Communications

Level 2, Ministry of Health Building

Commonwealth Drive, Brunei Darussalam