The importation of medicinal products into Singapore is regulated under the Medicines Act[1]. In addition, medicinal products containing Controlled Drugs listed under the Misuse of Drugs Act, eg. antiretroviral drugs, are subject to additional controls.
A medicine is described in the Medicines Act as a “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”.
Many Singaporeans and permanent residents living with HIV travel to Bangkok to buy cheap, generic antiretroviral drugs. Some even procure recreational drugs there to bring back to Singapore in their luggage. If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all supporting documents like a doctor's prescription must be ready for verification when requested. Individuals may not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
The importation of medicinal products into Singapore is regulated under the Medicines Act[2]. In addition, medicinal products containing Controlled Drugs listed under the Misuse of Drugs Act, eg. antiretroviral drugs, are subject to additional controls.
A medicine is described in the Medicines Act as a “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”.
Many Singaporeans and permanent residents living with HIV travel to Bangkok to buy cheap, generic antiretroviral drugs. Some even procure recreational drugs there to bring back to Singapore in their luggage. If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all supporting documents like a doctor's prescription must be ready for verification when requested. Individuals may not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Medicinal products not containing controlled substances[]
Medicinal products not containing any substance listed in Appendix A may be imported into Singapore without the need for prior approval from the Health Sciences Authority (HSA).
The quantity imported in each instance should not exceed 3 months' supply based on the dosage prescribed by the doctor or the dosage recommended by the manufacturer or supplier of the medicinal product.
The relevant supporting documents (i.e. a letter from the doctor and/or a copy of the prescription) should accompany the medicinal product(s) as proof that they are for personal medical use.
The person importing the medicinal product(s) shall take full responsibility for the use of the medicinal product(s) in Singapore.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
<br style="clear: left"/>
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[3].
Acknowledgements[]
This article was written by Roy Tan.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
<br style="clear: left"/>
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[4].
Acknowledgements[]
This article was written by Roy Tan.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
<br style="clear: left"/>
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[5].
Acknowledgements[]
This article was written by Roy Tan.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
<br style="clear: left"/>
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[6].
Acknowledgements[]
This article was written by Roy Tan.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
<br style="clear: left"/>
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[7].
Acknowledgements[]
This article was written by Roy Tan.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
<br style="clear: left"/>
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[8].
Acknowledgements[]
This article was written by Roy Tan.
Medicinal products containing controlled substances[]
Prior approval from the Health Sciences Authority (HSA) is required for each import of medicinal products containing any substance listed in Part I of Appendix A.
To apply for approval, this application form must be downloaded and the completed form must be submitted at least ten working days before the arrival date.
The following documents and information are required to be submitted with the application:
A copy of a doctor's letter or prescription verifying
- the need for the medicinal products
- the total quantity of the medicinal products to be imported into Singapore
- a copy of the travel itinerary indicating intended arrival and departure dates into/from Singapore (applicable for visiting tourists)
- a copy of the passport page with personal particulars
The application form must be submitted (preferably in one pdf file) via:
E-mail : hsa_info@hsa.gov.sg
Fax : (65) 64789068; or
Mail :
Audit and Licensing Division
Health Products Regulation Group
Health Sciences Authority
150 Cantonment Road, Cantonment Centre
Blk A, #01-02, Singapore 089762
Upon approval, the licence / permit will be sent to the applicant via email / fax.
Import of substances listed in Part II of Appendix A is prohibited as these substances have limited or no medicinal use.
Medicinal products containing Ephedrine and Pseudoephedrine
Routine check upon arrival
If an individual is bringing in the medicinal products with his personal belongings, he are not required to declare them upon his arrival in Singapore. However, all the supporting documents must be ready for verification when requested.
Individuals are reminded not to sell or supply the medicinal products to anyone in Singapore. For tourists visiting Singapore, the remaining medicinal products must be brought with them when they leave Singapore.
Availability of medicinal products in Singapore
If you need additional supplies of medicinal products while you are in Singapore, please seek advice from a pharmacist or consult a medical doctor in Singapore.
If the medicinal products needed are not registered in Singapore and there are no suitable alternatives available locally, a Singapore-registered doctor may seek approval from the Therapeutic Products Branch, Pre-Marketing Division, Health Products Regulation Group, HSA MedProd Enquiry (HSA) (HSA_MedProd_Enquiry@hsa.gov.sg) for a permit to import the medicinal products.
Helplines[]
For further clarification, enquiries may be e-mailed to the Health Sciences Authority's information service at: hsa_info@hsa.gov.sg
Alternatively, one may call Tel. (65) 6866 3522 or (65) 6866 3592 for assistance.
eForms[]
- The latest copy of the following application form must be downloaded at http://www.hsa.gov.sg
- The application form (Sections A to E) must be completed neatly in English and in BLOCK LETTERS.
- All mandatory fields (indicated red boxes) must be completed including the declaration in Section E. Incomplete forms will not be processed and will be rejected.
- Upon completing the form, click on the Save button at the top right hand corner on the first page to validate and save the form.
- The completed application form should be saved to the applicant's computer.
- E-mail or fax the completed application form and copies of the requested supporting documents (in Section D) to the HSA office. E-mail: hsa_info@hsa.gov.sg Fax: (65) 6478 9068
Product Licence[]
All medicinal products imported or sold in Singapore require the HSA’s Product Licence. 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 Licence will be issued. Depending on the nature of the product and the evaluation involved, the registration process will take from 60 to 270 days after the application has been screened and accepted.
Licences for import[]
Import Licence[]
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 Licence[]
Imports for the purpose selling to others, who resell the products, require Wholesale dealer’s Licence. 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 Licence (On consignment basis)[]
This licence is issued to importers, who are not product license holders or authorised 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 Authorisation letter from the Product Licence 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 the Licence 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 licence 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.
See also[]
References[]
- Tham Lijing, "The Curious Case of Drug Importation", Law Gazette, September 2013[9].
Acknowledgements[]
This article was written by Roy Tan.