Press Release

License of pharmaceutical company suspended

12 Mar 2009

The Licensing Committee of the Pharmacy and Poisons Board today (March 12) suspended the manufacturer's license of Marching Pharmaceutical Ltd for one month to facilitate investigations into the operation of the company which had failed to comply with the standard of Good Manufacturing Practice (GMP) in the production of 216 pharmaceutical products (annex 1

The label expiry dates of the products concerned were found to be not substantiated by laboratory data, a spokesman for the Department of Health (DH) said.

He reiterated that risk assessment made by the department so far concluded that the case only involved the stability and not the safety of the pharmaceutical products concerned.

However, DH will continue its thorough investigations into the case, with emphasis on the application by the company for de-registration of 120 of the 216 products.

"We will further examine if the application was related to any hidden malpractice affecting public health," the spokesman said.

DH yesterday instructed the company to recall the 216 products orderly including setting up hotline and providing brand names of the products to the retailers and public with details e.g. collection spots (annex 2).

"The department today reminded the company to strictly observe the recall procedures and requirements.

"DH will continue to closely monitor the actions taken in the recall exercise to ensure that all the necessary steps are effectively and efficiently adhered to," the spokesman said.

The spokesman said the case had also been reported to the Police as during the course of DH investigations, certain irregularities in the documents submitted by the company were found.

Meanwhile, DH would conduct a thorough review of the existing pharmaceutical regulatory framework which included routine inspections, market surveillance and enforcement with a view to further enhancing its effectiveness to protect public health, the spokesman said

The spokesman called on members of the public in possession of any of the 216 products to stop using the products and to contact Marching Pharmaceutical Ltd through its hotline 2781 6320 for recall arrangements. They can also call DH's hotline 2125 1122 for advice.

The brand names of the 216 pharmaceutical products are available at DH websitehttps://www.dh.gov.hk/english/press/2009/files/marching_list(090311).pdf.