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Frequently Asked Questions

Health Products Regulation

Manufacturing, Importation & Distribution > Therapeutic Products > Licence Requirements (General)

1.
What is the procedure to apply for Importer’s Licence (IL) and Wholesaler’s Licence (WL) to import and wholesale Therapeutic Products (TP)?

The application for IL and/or WL can be submitted online via ‘Apply for Licence to Import and/or Sell Therapeutic Product by Wholesale modules under apply@prism on PRISM e-Services webpage. Please refer to Guide on New Application for Importer’s Licence and/or Wholesaler’s Licence for Therapeutic Products when making an application. As part of the application, supporting documents such as the store layout plan, and Standard Operating Procedures (SOPs)/ Records/ Forms that serve to demonstrate compliance with the requirements stipulated in the Guidance Notes on Good Distribution Practice (Last update in August 2015) should be submitted. 

For therapeutic product not registered under the applicant’s name, a letter of authorization given by the product registrant has to be submitted. If the Responsible Person (RP) is a registered pharmacist, the Pharmacist Practising Certificate is also required. Completeness of these documents and a satisfactory outcome of the site audit are pre-requisites for the approval of the application.

2.
Do companies holding Product Registrations need to apply for new licences under the Health Products (Therapeutic Products) Regulations?

Under the Health Products (Therapeutic Products) Regulations, companies need to apply for Importer's Licence (IL) and Wholesaler's Licence (WL) to import and wholesale Therapeutic Products (TP) respectively. This ensures that there is regulatory oversight on companies carrying out these activities.

As such, companies previously holding product registrations (i.e. product registrants) and who are importing and/or wholesaling their own registered TP need to apply for the appropriate licence to continue such activities.

Although new licences are required, companies may apply for both the IL and WL in a single application form to qualify for a lower bundled application fee (see Fees).

For more information on the requirements for IL and WL, please click here. To apply for IL and WL, please click here.

3.
What should first time applicants for Importer's Licence (IL) and Wholesaler's Licence (WL) take note of and where can we get more information about IL and WL applications?

An overview of the IL and WL for Therapeutic Products can be found here.

Some of the considerations you should take note of include:-

(1) To maintain an effective quality system that complies with HSA’s Good Distribution Practice (GDP) standards. For more information, please refer to Guidance Notes on Good Distribution Practice (Last update in August 2015).

(2) To nominate one or more Responsible Person (RP) to be named in the IL and/or WL. The RP is a person employed and appointed by your company to implement and maintain an effective quality system that meets HSA’s GDP standards. For more information on the responsibilities of the RP, please refer to Guidance Notes on Duties of Responsible Persons Named in the Importer’s Licence and Wholesaler’s Licence. 

Companies may apply for both the IL and WL in a single application to qualify for a lower bundled application fee (see Fees). 

4.
When applying for the Importer’s Licence (IL) and Wholesaler’s Licence (WL) for Therapeutic Products (TP), do I need to apply for any other licences?

The IL and WL for TP are issued for your company to deal with TP. If you are also dealing in Chinese Proprietary Medicines, Controlled Drugs or other category of products, other relevant licences are required.

5.
For the Importer’s Licence and Wholesaler’s Licence for Therapeutic Products, how should we prepare for the audit and how are the audits conducted?

During the audit, your company’s quality system and premises would be assessed for compliance with the HSA’s Good Distribution Practice (GDP) standards. As such, you are advised to be familiar with the Guidance Notes on Good Distribution Practice (Last update in August 2015) and ensure that the premises and quality system (Standard Operating Procedures, Records, Forms, etc.) are available for the audit.

Upon receiving the application via PRISM, an officer will contact you to arrange for a suitable date for the audit. All deficiencies raised during the audit would have to be satisfactorily addressed and a follow-up audit may be conducted to verify your proposed corrective actions. If the outcome of the audit was satisfactory, the licence will be issued within 10 working days from the date of close-out of the audit (excluding any stop-clock time incurred by the applicant).

Following approval of the licence, regular routine audit will be conducted to assess your company’s continued compliance with the requirements in the Guidance Notes on Good Distribution Practice (Last update in August 2015). The frequency of the routine audit would depend on risk factors including the activities conducted by your company as well as your level of compliance. Unannounced audit may also be conducted should circumstances arise.

6.
When do I need to renew my Importer’s Licence and Wholesaler’s Licence?

The licence is valid for 1 year. Renewal notices and reminders will be sent to the licensee 60 days before expiry via the preferred mode of contact.

If your company has a GIRO account with HSA, the licence will be automatically renewed upon successful deduction of the licence fee. If your company does not wish to renew the licence, an application to opt-out of auto-renewal should be submitted at least 1 month before the expiry of the licence.

If your company does not have a GIRO account with HSA, you should remember to login PRISM and use the “Renew Licence to Import Therapeutic Product” and/or “Renew Licence to Sell Therapeutic Product by Wholesale” modules under renew@prism on PRISM e-Services webpage to submit a renewal application before the licence expires. You may submit the application 2 months before the expiry of the licence. Please refer to the Guide on Renewal Application for Therapeutic Products Importer's Licence and Guide on Renewal Application for Therapeutic Products Wholesaler's Licence when renewing your licence.

If your licence is not renewed upon expiry, it would be considered lapsed and you would not be able to continue with the activities previously authorized under that licence. A lapsed licence would not be renewed and a new application would have to be made. You are encouraged to apply for a GIRO account with HSA and maintain sufficient funds for licence fee deductions, to prevent inadvertent lapses of licence validity.

Please click here for more information on the application fee. 

7.
Does the implementation of Health Products (Therapeutic Products) Regulations have any impact on my dealing in Active Pharmaceutical Ingredients (API)?

No, the regulatory controls under the Health Products (Therapeutic Products) Regulations are only applicable to Therapeutic Products (finished products) intended for human use. They are not applicable to other products such as API, laboratory reagents/standards and veterinary products etc.

For the definition of Therapeutic Products, please click here.

8.
Do companies require an Importer’s Licence (IL) to import Active Pharmaceutical Ingredients (API)?

No, companies are not required to hold an Importer’s Licence to import API. Importer’s Licence is required under the Health Products (Therapeutic Products) Regulations for the import of Therapeutic Products (finished products) intended for human use.

However, if an API is a scheduled poison, it remains under the regulatory controls of the Poisons Act and companies are required to hold Form A Poisons Licence.

9.
Do companies still need to hold a Form A Poisons Licence (FAPL) to deal in products containing poisons?

Yes, companies still need to hold a FAPL to deal in products containing poisons, such as Active Pharmaceutical Ingredients, laboratory reagents/standards and veterinary products etc.

However, the regulatory controls of the Poisons Act no longer apply to Therapeutic Products (TP). Therefore, a FAPL is not required if your company is solely dealing in TP and not any other products containing poisons.

10.
Since Poisons Act is no longer applicable to Therapeutic Products (TP), can a pharmacist continue to purchase TP from the distributor without a Form A Poisons Licence (FAPL)?

Yes, a pharmacist working for a licensed retail pharmacy business or a licensed wholesale business can continue to purchase TP (finished products) from distributors for business purposes without a FAPL.

However, please note that the regulatory controls under the Poisons Act remains applicable to other types of products containing scheduled poisons such as Active Pharmaceutical Ingredients, laboratory reagents/standards and/or veterinary products. A pharmacist dealing in poisons other than those in the form of finished TP is required to hold a FAPL to deal in these poisons.

11.
What are the regulatory controls and licences required for my supply of Therapeutic Products (TP) that are prescribed for veterinary use? For example, can my retail pharmacy still fill a prescription for such TP requested by a veterinarian?

The regulatory controls under the Health Products (Therapeutic Products) Regulations are only applicable to TP intended for use in humans.

Your supply of any products (including TP) at retail pharmacies and/or by wholesalers for the eventual use in animals comes under the purview of the Agri-Food & Veterinary Authority of Singapore (AVA).Therefore, the supply and the conditions pertaining to such supply for use in animals must fulfil the requirements stipulated by AVA. 

In general, HSA-licensed retail pharmacies and wholesalers may continue to supply TP for animal use based on valid veterinary prescriptions and signed (purchase) orders from Agri-Food & Veterinary Authority (AVA)-licensed veterinarians, veterinary clinics, feedmills, farms and AVA-registered wholesalers* which are supplying TP solely for veterinary use.

*The “List of Registered Wholesalers of Therapeutic Products for Veterinary Purposes” can be located by selecting “Circulars” and “Pets & Animals” under the search function in the AVA newsroom webpage.

For any enquiry or feedback relating to veterinary products, please contact AVA at AVA_Import&Export_Animals@ava.gov.sg or call 6805 2991.

12.
Does my company need to obtain a separate Good Distribution Practice (GDP) Certificate before making an application for an Importer's Licence (IL) or Wholesaler's Licence (WL) for Therapeutic Products (TP)?

No, your company does not need to obtain any GDP Certificate prior to applying for an IL or WL since this is not a prerequisite of the application. HSA will audit your company to assess for GDP compliance before an IL or a WL for TP is granted.

For more information on HSA’s GDP standards, please refer to the Guidance Notes on Good Distribution Practice (Last update in August 2015).

13.
Does my company need to hold separate Importer's Licence (IL) for different Restricted Activities conducted (for example, to import for re-export, for non-clinical use or for ships/aircraft use)?

Generally, your company needs to apply for one IL to cover all ranges of import activities which include importing TP for local supply and/or for one or more restricted activities, such as import solely for re-export, non-clinical use or for use in ships and/or aircrafts.

However, if your company imports TP for restricted activities only, but on an infrequent basis, you can apply for a one-off IL for each consignment of TP on different occasions to cater for business needs.

If you conduct these restricted activities on more than one occasion in a year, you can consider applying for a term IL for Restricted Activities on an annual basis instead (see Fees).

14.
What must I do if there are changes, such as in the types of activities and/or types of Therapeutic Products (TP), to what were previously approved in the Importer’s Licence (IL) and Wholesaler's Licence (WL)?

You need to submit an amendment application and obtain prior approval for any changes in the scope of activities previously approved in your licences before the changes can be implemented. Such changes in scope may include but are not limited to:-

(i) adding or removing other aspects of activities e.g. addition or removal of import of unregistered TP in the IL;

(ii) dealing in another type of TP e.g. cold chain products, Prescription-only TP and/or Pharmacy-only TP or General Sale List TP;

(iii) changes in warehouse address; and/or

(iv) changes in Responsible Person.

Amendment application can be submitted via ‘Amend Licence to Import Therapeutic Products’ and/or ‘Amend Licence to Sell Therapeutic Products by Wholesale’ modules under amend@prism on PRISM e-Services webpage. Please refer to the Guide on Amendment Application for Importer’s Licence for Therapeutic Products and/or Guide on Amendment Application for Wholesaler's Licence for Therapeutic Products when making an amendment application.

Please click here for more information on the application fee.

15.
How do I submit an amendment to change company information or applicant details for the Importer’s Licence and Wholesaler’s Licence for Therapeutic Products?

For changes in company’s business address or company name (but no change to the company’s Unique Entity Number, i.e. UEN), you can submit amendment via the ‘Amend Company Information’ module under amend@prism on PRISM e-Services webpage. 

For changes in applicant details, you can submit amendment via the ‘Amend Applicant’s Details for Licences and Applications’ module under amend@prism on PRISM e-Services webpage.

16.
If I leave the company, do I have to cancel the Importer’s Licence (IL) and Wholesaler’s Licence (WL)?

The IL and WL for therapeutic products (TP) are issued to your company. Cancellation of licence would only be required when your company decides not to import or wholesale TP. You can submit a cancellation application via ‘Cancel Licence to Import Therapeutic Products’ and/or ‘Cancel Licence to sell Therapeutic Products by Wholesale’ modules under cancel@prism on PRISM e-Services webpage. Please refer to the Guide on Cancellation Application for Therapeutic Products Importer's Licence and Guide on Cancellation Application for Therapeutic Products Wholesaler's Licence when cancelling licence.

17.
Does my company still need to comply with those terms and conditions listed in the licence issued by HSA under Medicines Act but which are not specified in the Therapeutic Product (TP) Manufacturer’s Licence, Importer’s Licence or Wholesaler’s Licences?

Some of the terms and conditions which were previously listed in the licences issued under the Medicines Act have already been incorporated as regulatory requirements into the Health Products (Therapeutic Products) Regulations. Thus, these are not repeated as licensing conditions in the TP Manufacturer’s Licence, Importer’s Licence or Wholesaler’s Licences. Your company should comply with the regulations specified in the legislation and the terms and conditions listed in your licences issued under the Health Products (Therapeutic Products) Regulations. Please refer to the duties and obligations of the Manufacturer, Importer and Wholesaler which are stipulated under the Health Products Act and its regulations.

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