Importing Healthcare Products into Singapore Part 2: Importing Western Medicine
A medicine is described in the Singapore Medicines Act as “Substance used for administration to human beings and animals for the diagnosis, prevention or treatment of ailments including preparations intended for the promotion of health, for anesthesia or for contraception”.
This guide provides a brief overview of the various regulations and requirements for importing medicines (popularly known as western medicine) into Singapore. For a general overview of the regulatory regime for importing other types of healthcare products, refer to Importing Health Care Products into Singapore – An Overview. Note that this is neither a comprehensive compilation of requirements nor a professional advice but just a general overview.
PRODUCT LICENSE
All medicinal products imported or sold in Singapore require HSA’s Product License. Therefore a locally registered company that is responsible for the safety, quality and efficacy of the product must obtain a Product License from the HSA.
Singapore has a New Drug Application (NDA) and a Generic Drug Application (GDA) process. For products already approved by certain regulatory agencies (such as Australia’s TGA, the US FDA, etc.), submitting an abridged dossier is possible. Applicants submit an online application through PRISM (Pharmaceutical Regulatory and Information System) and also submit an accompanying dossier. Accompanying dossier must be in International Conference on Harmonization (ICH) Common Technical Document (CTD) format or the ASEAN Common Technical Document (ACTD) format.
The applications are first screened for any deficiency and discrepancy. Upon correction and fulfillment of details the application will be accepted for evaluation.
Three types of evaluations are applicable as the case may be:
- Full Dossier: applies to any product that has not been approved by any drug regulatory agency at the time of submission.
- Abridged Dossier: Applies to any product that has been evaluated and approved by at least one drug regulatory agency.
- Verification Dossier: Applies to any product that has been evaluated and approved by HSA’s reference drug regulatory agencies.
After evaluation and upon an approval of regulatory decision, a Product License will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take between 60 to 270 days after the application has been screened and accepted.
LICENSES FOR IMPORT
Import License
Importers, who do not hold the Product License but are Authorized Agents of the holders of Product License, can apply for an Import License. The company, which is applying for an Import Licence as Authorized Agent, must demonstrate compliance with standards of Good Distribution Practices (GDP) set out by the HSA.
Good Distribution Practice are standards to ensure medicinal products are stored and handled consistently under appropriate conditions as required by the marketing authorization or product specification so that the quality of the products will be maintained during storage and distribution.
Wholesale dealer’s License
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s License. Compliance with the standards of GDP is a prerequisite to obtain this license. It must be noted that licensed manufacturers, who sell to others for the purpose of reselling do not require a license.
Import License (On Consignment Basis)
This license is issued to importers, who are not product license holders or authorized agents, to import registered products on a per consignment basis. In order to obtain this license the applicant must prove to the licensing authority that the product to be imported is in all respects the same as the medicinal product registered in Singapore.
Importation of Medicinal Products for Re-Export
HSA’s approval is required for the importation of medicinal products into Singapore, where the intention is to export these products to other countries. Each consignment must be imported within six months of the approval date. Currently, no fee is charged for obtaining approval. However, the consignment must be exported from Singapore within two years from the date of import.
APPLICATION PROCEDURE
Application must be accompanied by relevant documents such as Authorization letter from the Product License holder, records of compliance with GDP, standard operation procedure, store layout etc as the case may be.
Applications can be submitted online via Pharmaceutical Regulatory Information System (PRISM).
Issuance of License will be preceded by an audit by the inspectors from the HSA to ensure GDP compliance. Suitable audit date may be arranged and any non-compliance notified must be corrected and failure to respond within three months from date of license application will cause the application to lapse.
After approval of license there will be routine audits by HSA inspectors, unannounced audits are also normal. Any changes to the venue of storage, list of authorized products should be notified to the HSA by submitting an amendment application.
Applications thus issued are valid for a period of one year and must be renewed via an application made two months before the expiry of the current license. Renewal is not possible upon the expiry of license and fresh application has to be filed.
For information about importing other types of healthcare products into Singapore, refer to the following guides: