05 Feb 2014, BioSpectrum Bureau , BioSpectrum
Singapore: Hong Kong-based DKSH, a provider of market expansion services, has obtained "License for Manufacturer (secondary packaging)" and the "License to Manufacture Preparations of Dangerous Drugs", issued by the Hong Kong Department of Health, enabling to provide uninterrupted continuation in the provision of its services in secondary packaging in 2014.
The new license fulfills new requirements set out by the Department of Health starting in 2014 in Hong Kong for secondary packaging, an important process in the pharmaceutical value chain that ensures products are labeled and packed according to local regulations.
Since January 1, 2014, all secondary packaging activities, including labeling, re-labeling, cartooning, re-cartooning or adding additional information (including inserts) to pharmaceutical products should only be performed by holders of the "License for Manufacturer (secondary packaging)". The Department of Health in Hong Kong issues this license to market expansion services providers, distributors and wholesalers, who can fulfill both legal and good manufacturing practices (GMP) requirements for secondary packaging.
DKSH Hong Kong also secured the "License to Manufacture Preparations of Dangerous Drugs", under which a registered pharmacist is required to supervize the dangerous drugs secondary packaging process.
"We are very proud that DKSH Business Unit Healthcare in Hong Kong is among the first Market Expansion Services providers to fulfill all the new regulatory requirements and successfully passed all the on-site inspections to obtain these licenses," said Mr Richard Holloway, VP, business unit healthcare, DKSH Hong Kong.
He added, "Secondary packaging is a critical step in the value chain, which may affect the quality and integrity of pharmaceutical products. Since 2009, DKSH has been accredited by SGS, the world's leading certification auditing company, to fulfill WHO GMP standards for secondary packaging. We are glad to have full capabilities and to have gained accreditation to perform this service well before this is required by the government body. At the moment, over 50 percent of our clients rely on DKSH to provide secondary packaging services for them. We will make sure to increase that number in the future by continuously enhancing our services while complying with upcoming regulation changes."