Overview
You will need a Form A Poisons Licence (FAPL) issued under the Poisons Act to import, store and wholesale products containing poisons such as active pharmaceutical ingredients (API), laboratory reagents and veterinary products.
If your core business is in the wholesale of API containing poisons intended for local clinical use, your company must comply with Good Distribution Practice standard.
Note: The Poisons Act does not apply to cell, tissue and gene therapy products, therapeutic products or medical devices containing poisons. This means that you do not need a FAPL to import and wholesale a cell, tissue and gene therapy product, therapeutic product or a medical device containing poisons.
If you hold a valid manufacturer’s licence for therapeutic products, you are also not required to apply for a FAPL to import and store substances or products containing poisons that are required for carrying out the manufacture of your therapeutic products. This includes API or products that are required for quality control testing during the manufacture of therapeutic products such as test reagents.
Dealing in controlled drugs or psychotropic substances?
If you are dealing in products containing controlled drugs or psychotropic substances, you will also need to apply for the relevant dealer's licence for controlled drugs or psychotropic substances.
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Principal licence holder
The appointed FAPL holder must be employed by your company and be given the responsibilities and accountabilities for all poisons transactions. There is no limit to the number of FAPL holders your company may appoint, but a principal licence holder must be appointed for each company. In general, the principal licence holder will be held responsible for any offence committed under the Poisons Act and Poisons Rules.
If your company is dealing with API containing poisons that are intended for local clinical use or controlled drugs, the principal licence holder must be a registered pharmacist. Otherwise, you can appoint a non-pharmacist to be the principal licence holder. However, non-pharmacist applicants should be familiar with the legal requirements stipulated in the Poisons Act and Poisons Rules, and are required to attend a briefing session before your applications can be approved. The briefing sessions will be arranged accordingly once we receive your application.
The validity of secondary FAPL is subject to the validity of the principal FAPL.