Poisons (Form A Poisons licence)
Regulatory Guidelines and Standards
Poisons are defined as any substances specified in the Schedule of the Poisons Act, Chapter 234. Any company, unless exempted under the Poisons Act, would need a licence for the purpose of import, possess for sale, sell or offer for sale any poisons.
Form A Poisons Licence (FAPL) is issued under the Poisons Act to allow the licensee to import, store and sell poisons by way of wholesale at the premises stated in the licence.
The licensee for FAPL must be working full time for the company and be given the responsibilities and accountabilities for all poisons transactions.
There is no limit to the number of FAPL holder a company may appoint. However, a principal licence holder should be appointed for each company. For the secondary licence holders, the validity of their licences is subject to the continued validity of the FAPL of the principal licence holder. For companies which are not dealing with Active Pharmaceutical Ingredients (API) that are intended for local clinical use or controlled drugs, the company can appoint non-pharmacists to apply to be the licence holders.
For companies which are dealing with poisons that fall in the above-mentioned categories, the principal licensee must be a registered pharmacist. Without prejudice to the liability of any person who may be licensed, the principal licensee shall be held responsible for any offence committed under the Poisons Act and Poisons Rules.
Non-pharmacists applicants should be familiar with the legal requirements stipulated in the Poisons Act and Poisons Rules. They are required to attend a briefing session before their applications can be approved.
For companies, with core business in wholesale dealing of API intended for local sales, they are expected to comply with HSA's Good Distribution Practice Standard.
Form A Poisons Licence (FAPL) is not required for dealings in Therapeutic Products (TP). However, FAPL is still required for dealings in other product categories containing poisons such as Active Pharmaceutical Ingredients (API), laboratory reagents and veterinary products etc.
Licensed manufacturers of TP importing substances (e.g. API and test reagents) containing poisons for use in the manufacture of their own TPs, including QC testing, are not required to hold FAPL.
With effect from 1 November 2016, some of the licensing conditions reflecting in the existing Form A Poisons Licence (FAPL) will be revised. The revisions include the following: