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This application is a service of the Singapore Government.

Health Sciences Authority

Key Features and Changes

HEALTH PRODUCTS (THERAPEUTIC PRODUCTS) REGULATIONS 2016

CHANGES TO THE LICENSING FRAMEWORK

Some of the key changes in the licensing framework include:

  1. Change in names of licences:

    Medicines Act Health Products Act (w.e.f. 1 Nov 2016)
    Product Licence Product Registration (PR)
    Manufacturer’s Licence Manufacturer’s Licence (ML)
    Import Licence Importer’s Licence (IL)
    Wholesale Dealer’s Licence Wholesaler’s Licence (WL)
    Certificate of Registration of a Pharmacy Pharmacy Licence (PL)

    Please click here for details on Product Registration.
     

  2. Activity-based licensing

    Under the HPA, an activity-based licensing framework is adopted for the registration, manufacture, import and wholesale of TP in Singapore. This means licensing will be required based on activities of TP dealt with by the company.

    Activities to be carried out Licence required under the Health Products (Therapeutic Products) Regulations 2016
    Importing a TP Importer’s Licence1,2
    Wholesale of TP Wholesaler’s Licence1
    Manufacturing of TP Manufacturer’s Licence

    1 Companies with Product Registration (‘Product Registrants’) are required to hold an Importer’s Licence (IL) and/or Wholesaler's Licence (WL) if they are importing and/or wholesaling their own registered TP.
    2 Companies intending to only import TP solely for export, import TP for supply to ships/aircraft, and/or import TP for non-clinical purposes, may choose to only hold an Importer's Licence for Restricted Activities.

    Please click here for details on the dealer licensing framework and requirements.

  3. Form A Poisons Licence is not required for dealings with therapeutic products (TP)

    As the Poisons Act is not applicable to TP, the Form A Poisons Licence is not required for dealing in TP.

    However, the Poisons Act will remain applicable to other products containing poisons such as active pharmaceutical ingredients (API), laboratory reagents and veterinary products etc. Form A Poisons Licence is required for dealings with these products except for licensed manufacturers importing API containing poisons which are used in their manufacture of TP will be exempted from holding a Form A Poisons Licence.

     

  4. Requirement to appoint a ‘Responsible Person’ in the Importer’s Licence (IL) and Wholesaler’s Licence (WL)

    Under the Health Products (Therapeutic Products) Regulations 2016, the IL and WL holders (the ‘licensee’) are required to name at least one Responsible Person (RP) in their respective IL and WL. The RP is a person employed and appointed by the licensee to implement and maintain an effective quality system that meets Good Distribution Practice (GDP) standard. Details on the duties and responsibilities of the RP are found in the Regulation 39 of the Health Products (Therapeutic Products) Regulations 2016.

    For companies dealing with Pharmacy-only medicines or Prescription-only medicines, the RP named in the IL and/or WL must be a registered pharmacist or such other persons as approved by HSA. As the importer and wholesaler of TP would no longer need to hold a Form A Poisons Licence, this requirement for Form A Poisons Licence holder is transferred to the naming of an RP in the IL and WL.

    For more information, please refer to the Guidance Notes on Duties of Responsible Persons Named in The Importer’s Licence and Wholesaler’s Licence and the Frequently Asked Questions (FAQ) on Importer's Licence and Wholesaler's Licence for Therapeutic Products. These should be read in conjunction with the Health Products (Therapeutic Products) Regulations 2016
     

  5. Companies importing and wholesaling of TP for patients’ use only

    This is commonly referred to as the 'Named-patient exemption route' and will continue to be allowed to facilitate prompt access to therapies required to fulfil an unmet medical need. This special access route is termed as the import and wholesale of TP "for patients' use" under the HPA.

    Under the Health Products (Therapeutic Products) Regulations 2016, companies involved in the import and wholesale of TP for patients’ use need to apply for an IL and WL, as well as comply with Good Distribution Practice (GDP) requirements. GDP is an essential requirement to assure quality and safety of TP, through compliance with good record keeping, handling, storage and distribution standards. To assist companies in the transition, those importing and wholesaling unregistered TP for patient’s use only will be given a grace period to level up to the GDP requirements and their IL and WL fees for these activities will only be imposed after that period.

  6. Consignment notification not required for TP imported solely for export

    Under the Health Products (Therapeutic Products) Regulations 2016, companies involved in the import of TP solely for export are required to apply for an Importer’s Licence for Restricted Activities if they do not already hold an Importer’s Licence. These companies will no longer need to submit consignment notification for import and export clearance.

    Companies that submitted notifications before 1 November 2016 and whose consignment has not been completely exported by 1 November 2016, would need to apply for an Importer’s Licence for Restricted Activities.

RETAIL SALE OF GENERAL SALE LIST (GSL) VIA VENDING MACHINES

The access controls of therapeutic products (TP) in Singapore are calibrated based on the inherent risk of the TP and are categorised as one of the following:

  • Prescription-only medicines (POM): the supply can only be made by a practitioner or by a pharmacist according to a valid prescription by a practitioner.
  • Pharmacy-only medicines (P medicines): the supply can be made by or under the supervision of a pharmacist without a practitioner's prescription.
  • General Sale List medicines (GSL), which can be purchased off the shelves of any retailer.

The use of vending machines as an alternative supply channel for GSL is allowed, subjected to conditions as specified in regulation 15 of the Health Products (Therapeutic Products) Regulations 2016.

Please refer to the GUIDE-29 Guidance Notes on Supply of Registered General Sale List (GSL) Therapeutic Products and Other Medicinal Products via Automatic Vending Machines for further information.
 

KEY FEATURES OF POST-MARKETING OBLIGATIONS

The key features are described in the following section. For more information on post-marketing obligations and requirements, please click here.

  1. Duties to maintain records and reporting of product defects and adverse effects

    • Duties to maintain records and reporting of product defects and adverse effects

      The manufacturer, importer or registrant must maintain a record of every event or other occurrence that reveals any defect in the therapeutic product or that concerns any adverse effect arising from the use of the therapeutic product. This requirement is not new but details of such records are now stipulated in Health Products (Therapeutic Products) Regulations 2016.

    • Reporting requirements of product defects

      Upon becoming aware of any defect in the therapeutic product, every manufacturer, importer, supplier or registrant of a therapeutic product must report the defect to HSA as soon as possible within 48 hours if the defect represents a serious threat to public health; or in all other cases, within 15 calendar days.

        Current requirements New Requirements for Therapeutic Products after transfer to the Health Products Act
      Product defect reporting timelines Regardless of whether the surfaced information may or may not lead to a subsequent recall of the product:

      Within 24 hours
      Product defects that represent a serious threat to persons or public health:

      Within 48 hours

      All other product defects:

      Within 15 calendar days
    • Reporting requirements of serious adverse reactions (SARs)

      Upon becoming aware of any SARs arising from the use of the therapeutic product, every manufacturer, importer, supplier or registrant must report the event to HSA as soon as possible within 15 calendar days.

    •   Current requirements New Requirements for Therapeutic Products after transfer to the Health Products Act
      Adverse effect reporting timelines Fatal and life-threatening local adverse reactions:

      No later than 7 calendar days after first knowledge by the product licence holder, followed by as complete a report as possible within 8 additional calendar days.

      All other local serious adverse reactions:

      No later than 15 calendar days
      All local serious adverse reactions:

      No later than 15 calendar days
  • Duty to carry out risk management plan and submission of benefit-risk evaluation reports

    The following post-marketing requirements are not new but under the Health Products (Therapeutic Products) Regulations 2016, these requirements are now legislated.

    Registrants may be required to implement risk management plans to minimise risks relating to unsafe and inefficacious use of therapeutic products. A risk management plan may include, but is not limited to, the following:

    1. producing and distributing educational material;
    2. producing and distributing safety information;
    3. performing clinical studies of the therapeutic product;
    4. implementing active surveillance programmes of the therapeutic product;
    5. implementing programmes to restrict the supply of the therapeutic product.

     

    The registrant may also be required to submit benefit-risk evaluation reports relating to the therapeutic product, should significant safety concerns be identified during pre-market or post-market reviews of the product. When required, the report should be submitted, for an initial period of two years, at intervals of six months commencing from either the date of registration of the therapeutic product or its international birth date; and thereafter, annually, for the next three years, unless otherwise specified.

    Please refer to the following guidance documents for more information


    The above guidance documents should be read in conjunction with the Health Products (Therapeutic Products) Regulations 2016.

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HEALTH PRODUCTS (CLINICAL TRIALS) REGULATIONS 2016

The key features and changes are described in the following section. For more information on the clinical trial framework, please click here.

  1. Introduction of a Clinical Trial Authorisation (CTA) – Clinical Trial Notification (CTN) system for clinical trials of Therapeutic Products (TP)

    For clinical trials of TP, the Clinical Trial Certificate (CTC) system has now been replaced by a risk-based Clinical Trial Authorisation-Clinical Trial Notification (CTA-CTN) system, stratified according to the registration status of the investigational TP and whether its use in the clinical trial is in accordance with its approved label.The following table shows the comparison of the CTC system with the new CTA-CTN system for clinical trials of TP

     
    Current Requirement
    New Requirement under the Health Products Act
    Type of System
    CTC
    CTA
    CTN
    Regulatory processing timelines
    30 working days
    30 working days
    5 working days
    Clinical trials investigating
    • Locally unregistered TPs
    • Locally registered TPs not used in accordance with approved label
    Clinical trials assessing
    • Locally registered TPs used in accordance with approved label

    Previously, some observational clinical trials of required a CTC under the Medicines Act. Under the Health Products Act, observational clinical trials of TP will not require a CTA or CTN.

    For more information, please refer to the Guidance on Determining Whether a Clinical Trial Requires Clinical Trial Authorisation (CTA), Clinical Trial Notification (CTN) or a Clinical Trial Certificate (CTC).

  2. Alignment of consent requirements for vulnerable subjects in accordance with Mental Capacity Act

    The safeguards and consent requirements for the vulnerable subjects remain largely unchanged, except for clarifications to reflect the definition of legal representative defined under other applicable local legislation such as the Mental Capacity Act (MCA).

    For more information, please refer to the Guidance on Informed Consent in Vulnerable Subjects.

  3. Refinement of Labelling Requirements for Investigational Products (IP)

    Labelling elements for IP have been refined to align with international requirements. There will also be a measured degree of flexibility in allowing for alternative approaches to traditional labelling requirements, provided the key principles of labelling are not compromised.

    For more information, please refer to the Guidance on Labelling of Therapeutic Products and Medicinal Products Used in Clinical Trials

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HEALTH PRODUCTS (THERAPEUTIC PRODUCTS AS CLINICAL RESEARCH MATERIALS) REGULATIONS 2016

With the transfer of controls for therapeutic products (TP) to the HPA, several changes have been instituted to streamline and simplify the import and supply controls for TP, medical devices and medicinal products for human research use:

  1. Introduction of a new term “Clinical Research Material (CRM)”

    In place of the term “clinical trial material” which is specific to clinical trials, a new term, “clinical research materials” (CRM) has been introduced to
    • refer to any TP, medical device or medicinal product imported, locally manufactured or supplied for use in human clinical research
    • clarify that the imported, locally manufactured or supplied CRM could be for use in clinical trials that are regulated by HSA, as well as for other types of human clinical research that is not currently regulated by HSA.
    • allow for a single, simplified regulatory regime regardless of the type of product imported/supplied or the type of human clinical  research in which the product is to be used, thereby reducing the number of regulatory submissions.
  2. Notification system replacing import approval issuance system for CRM used in local clinical research

    Access to imported or locally manufactured CRM for use in local clinical research is facilitated through regulatory notification by the importer or local manufacturer. This notification system replaces the import approval issuance system.

    To further streamline the regulatory process and reduce the regulatory impact on stakeholders, the CRM notifications for trials regulated by HSA may be made as part of the clinical trial application/notification to HSA (i.e. there is no need for a separate notification process).

  3. Duties and obligations of local manufacturers, importers and suppliers of CRM

    Local manufacturers, importers, and suppliers (including sponsors) of CRM are required to comply with the following duties and obligations:

    • Restriction of supply of CRM to Institutional Review Board (IRB)-approved clinical research only;
    • Proper record keeping to assure traceability, accountability and appropriate handling of CRM;
    • Ensure the appropriate quality of the CRM; and
    • Proper reporting and management relating to safety and defects of CRM.

For more information, please refer to the Guidance on Clinical Research Materials.

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HEALTH PRODUCTS (ADVERTISEMENT OF THERAPEUTIC PRODUCTS) REGULATIONS 2016

Under the Medicines Act, HSA regulates advertisements and sales promotion of pharmaceutical products through a permit system as well as surveillance of the published advertisements.

Under the HPA, the permit system is removed for advertisements of therapeutic products (TP), and the regulatory controls are prescribed within the regulations. HSA will maintain oversight with its post-market efforts through surveillance and monitoring the TP advertisements published to ensure that companies comply with the prescribed rules and principles.

For more information on the prescribed rules and principles, please refer to the Explanatory Guidance to the Health Products (Advertisement of Therapeutic Products) Regulations 2016 and Frequently Asked Questions (FAQ) on advertisements for TP. These should be read in conjunction with the Health Products (Advertisement of Therapeutic Products) Regulations 2016.

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HEALTH PRODUCTS (LICENSING OF RETAIL PHARMACIES) REGULATIONS 2016

Under the Medicines Act, retail pharmacies are required to hold a Certificate of Registration of a Pharmacy and a Form A Poisons Licence.

Under the HPA, the Certificate of Registration of a Pharmacy has been renamed to Pharmacy Licence.

Medicines Act Health Products Act
Certificate of Registration of a Pharmacy Pharmacy Licence (PL)

Form A Poisons Licence will no longer be required if the retail pharmacy is dealing only in therapeutic products (TP).

Retail pharmacies intending to deal in other poisons such as active pharmaceutical ingredients (API), test kits/reagents/standards, and veterinary products are still required to hold a Form A Poisons Licence.

Please click here for details on licensing of retail pharmacies.

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