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                                                                                                                                                                                                                                          SINGAPORE PHARMBIO GUIDE 2021/2022
  Toxic industrial and biohazardous waste should be collected by NEA licensed collectors for off-site treatment and disposal. The generation and transportation of such waste are also tracked online through NEA’s e-Tracking system. An updated list of these collectors is available at NEA’s website.
Import, Storage
and Transport of Flammable Materials
Under the Fire Safety (Petroleum and Flammable Materials) Regulations 2005, a licence from the Singapore Civil Defence Force (SCDF) is required for the import, storage and transportation of petroleum and flammable materials (PFM) gazetted in the regulation. However, SCDF excuses premises that store PFM quantities below the exemption limits from the licence requirement. For example, premises storing less than 40 litres of scheduled liquid flammable materials do not need to apply for the storage licence. Additional information may be found at www.scdf. gov.sg.
Furthermore, SCDF publishes a set of technical guidelines and fire safety requirements for premises handling chemicals. The guidelines can be downloaded from the SCDF website. In addition to the published Fire Code (2013), SCDF adopts the Singapore Standards SS 641:2019 and SS 532:2007 as well as the US National Fire Protection Association
(NFPA) Standards NFPA 45 and NFPA 55 when regulating flammable materials storage and use.
Import Licence for poisons and controlled drugs
A Form A Poisons Licence is needed by companies that intend to import, store and/or sell any of the scheduled poisons controlled under the Poisons Act, Chapter 234 and its Subsidiary Legislation. Additionally, as a requirement under the Misuse of Drugs Act, a licence is required for possession, supply, import and manufacture of the scheduled controlled drugs. Both licences may be obtained from the Centre for Drug Administration (CDA), Health Sciences Authority (HSA) (www.hsa.gov.sg).
Manufacture, Importation & Distribution of Pharmaceuticals
The Health Sciences Authority (HSA) (www.hsa.gov.sg) in Singapore serves as the regulator of manufacturing, importation and distribution of medicinal andmedicaldeviceproducts.Therelevant Manufacturer’s and Dealer’s licences may be applied via the HSA’s online application system known as PRISM@ HSA. Furthermore, all manufacturers will be periodically audited by HSA in accordance with the current international Good Manufacturing Practices (GMP) as
well as the relevant Good Distribution Practices(GDP)standards.
National Authority (Chemical Weapons Convention) NA(CWC) Licence
A NA(CWC) licence is required for the production, processing, consumption, import/export and/or local sale/ distribution of chemicals controlled under the CWC. Details on the scheduled chemicals and the application forms are available at www.customs.gov.sg.
Licence to possess & store Explosive Precursors
Under the Arms and Explosives Act, a licence from the Singapore Police Force is required to import, possess, deal in, manufacture and/or store a series of identified explosive precursors, some of which are oxidising agents commonly used for lab chemistry and industrial applications. Protective security measures as well as threat and risk assessments are to be in place prior to licence issuance. Applications may be filed online at www. spf.gov.sg.
Imports of Pathogens
The Biological Agents and Toxins Act 2006 (BATA) regulates the possession, usage, import, transfer and transportation of scheduled biological agents and toxin
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