SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
A wholesaler’s licence is not required if the wholesal- ing is for a clinical purpose in clinical research. A wholesaler’s licence is generally valid for 12 months from the date of licence approval. Renewals must be submitted and processed before the expiry of the licence. 6.2 Different Classifications Applicable to Pharmaceuticals Therapeutic products in Singapore are classified as Prescription Only Medicines, Pharmacy Only Medi- cines and General Sale List Medicines. Prescription Only Medicines may only be supplied by a registered medical practitioner or pharmacist in accordance with a prescription. Pharmacy Only Medicines may be sup- plied by a pharmacist without a prescription, and Gen- eral Sale List Medicines can be freely obtained from any retailer. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The import and export of therapeutic products and medical devices are governed by the Health Prod- ucts (Therapeutic Products) Regulations 2016 and the Health Products (Medical Devices) Regulations 2010, respectively. In addition, all goods imported into Sin- gapore are regulated under the Customs Act 1960, the Goods and Services Tax Act 1993 and the Regulation of Imports and Exports Act 1995. The Singapore Customs applies and enforces import regulations at the point of entry; thereafter, the regula- tions are applied and enforced by the HSA. 7.2 Importer of Record of Pharmaceuticals and Medical Devices A licensed importer or licensed wholesaler of thera- peutic products has to appoint a responsible person who is able to implement and maintain the quality system to meet the Good Distribution Practice (GDP) Standard. For Pharmacy Only Medicines or Prescrip- tion Only Medicines for local use, or unregistered therapeutic products for patients’ use, only a qualified
pharmacist may act as the responsible person under an importer’s licence. There are no specific require- ments regarding the importer of record of medical devices. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices An importer’s licence is required to import therapeutic products and medical devices. In general, only regis- tered therapeutic products and medical devices may be imported. There are certain exemptions from holding an import- er’s licence, including the following: • a healthcare institution may import an unregistered therapeutic product without a licence, on a named- patient basis with the prior approval of the HSA; • a person may import a therapeutic product that does not contain psychotropic substances or amounts of codeine and dextromethorphan greater than that specified by the HSA without a licence for personal use with the prior approval of the HSA; • a licensed manufacturer may import any therapeu- tic product or medical device if required for the purpose of carrying out the licensed manufacture of a therapeutic product or another medical device; and • medical devices may be imported without a licence for personal use subject to conditions set out by the HSA or for use in a clinical purpose in any clini- cal research. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports Harmonised System (HS) codes are required in Sin- gapore in the permit declaration of goods, and are used to determine the tariffs, controls and rule of ori- gin applicable to the relevant goods. The HS code of goods used in Singapore is an eight-digit code known as the ASEAN Harmonised Tariff Nomenclature code. The HS codes are listed in the Singapore Trade Clas- sification, Customs and Excise Duties, published by the Singapore Customs. 7.5 Trade Blocs and Free Trade Agreements Singapore is part of the ASEAN trade bloc and is a party to free trade agreements containing provisions
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