Malaysia: Updated Marketing Authorization Holder (MAH) Procedures

In Malaysia, only local distribution companies can submit a pharmaceutical product registration application. Therefore, foreign companies with no local presence in Malaysia must use a MAH as their local representative. The MAH is responsible for the product application, as well as the quality, safety and efficacy of the product. Companies wishing to change their MAH may do so through a specific application process. Recently, Malaysia’s Drug Control Authority (DCA) under the Ministry of Health released new guidance on the transferring of Marketing Authorization Holders (MAHs).

Before applying for a MAH transfer, several conditions must be met. First, no other changes may be included in the MAH transfer, such as a change in labeling or technical data; only the MAH name and address can be changed. Second, the current product registration should be valid for at least six months. If it is valid for less than six months, the current MAH should renew the registration first, prior to the transfer. Third, the new MAH should submit the transfer application.

The following are required for the application submission: (1) transfer application form, either submitted as a hard copy or online; (2) confirmation letter/agreement between the current MAH, new MAH and product owner agreeing to the transfer; and (3) a nonrefundable application processing fee. Once the application is approved by the DCA, the new MAH license will be valid for the time remaining on the previous MAH license. The product registration number will remain unchanged.