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Supply of registered therapeutic products through e-pharmacy

Understand the requirements to supply registered therapeutic products (TP), Prescription-Only medicines (POM) and Pharmacy Only medicines (P), through e- pharmacy service by licensed retail pharmacies in Singapore.

Introduction

The Health Sciences Authority (HSA) is putting in place appropriate fit-for-purpose requirements for pharmacies providing e-pharmacy service directly to the patients. This new mode of pharmacy service can offer patients with greater convenience and wider healthcare options. The rollout of the e-pharmacy service commences on 05 May 2020.

HSA-licenced retail pharmacies and wholesalers in Singapore with good track record in handling POM and P, may apply for a retail pharmacy licence or include such services in their existing retail pharmacy licence if they intend to carry out e-pharmacy operations. HSA will assess these applicants for compliance with our regulatory requirements before approval to start e-pharmacy operations. The regulatory requirements are needed to ensure that the right medicines of the appropriate quality are supplied to the correct patients as prescribed by the patients’ doctors.

Patients are strongly advised to only purchase therapeutic products from these licensed retail pharmacies and the corresponding e-commerce platforms in Singapore, to ensure that the products are from a reliable source.    

What is e-pharmacy

E-pharmacy is a mode of pharmacy service that utilises technology to better serve patients by providing more convenient access to pharmacy services. This new mode of pharmacy service is provided by a licensed pharmacy in Singapore using a secured online platform. Prescriptions are transmitted electronically through a closed-loop electronic interface from the qualified practitioner or collaborative prescribing practitioner to the qualified pharmacist. The qualified pharmacist processes the received valid prescriptions through electronic means, and conducts professional counselling remotely, as needed. The medicines are then delivered directly to the patients, who enjoy the convenience of not having to go down to a physical retail pharmacy outlet to fill their prescriptions.

Supplying of registered therapeutic products through e-pharmacy services

Applicant/Company who qualifies to supply registered therapeutic products (i.e. POM and P) through the mode of e-pharmacy must implement good governance and practices in operations. It must also have an effective system to ensure good, quality medicines are supplied to patients. Before submitting an application, company should assess that they have met the following regulatory requirements:

  1. Licensee is a Singapore registered business and holds a retail pharmacy licence or TP wholesaler’s licence issued by HSA;
  2. Has its e-pharmacy services hosted on a Singapore domain;
  3. Is ready to be assessed by HSA for the e-pharmacy operations;
  4. All medicines supplied by the e-pharmacy must be registered with HSA and obtained through licensed manufacturers and dealers to ensure the safety, quality and efficacy of the TP supplied
  5. Appoints a competent qualified pharmacist as the pharmacist-in-charge to be responsible for the pharmacy operations, including proper storage and supply of the registered therapeutic products;
  6. Operates suitably designed and well maintained premises to perform the e-pharmacy activities;
  7. Has e-pharmacy infrastructure with necessary safeguards / controls to ensure security, integrity, accuracy and confidentiality of the system used;
  8. Ensures that the e-pharmacy has a closed loop system for the transmission of e-prescriptions, i.e. the e-prescriptions are sent directly from the medical clinics to the e-pharmacy, so that the e-prescriptions cannot be changed or reused, are traceable to the prescribing doctor, and with cybersecurity in place;
  9. Establishes clear procedures and practices for the storage, packing, labelling and secure delivery of medicines to the intended patients in accordance with the e-prescriptions received, and with the appropriate professional supervision by a qualified pharmacist in compliance with the Singapore Standard on Supply and Delivery of Medications and Good Distribution Practice (GDP) requirements.  There should also be adequate patient interface processes to handle calls and queries related to medicines supply;
  10. Establishes suitable Quality systems, including documentation and record keeping; internal audits, to ensure traceability of operations and control of e-pharmacy services;

           

For a start, e-pharmacies are not allowed to fill prescriptions electronically or make home deliveries for Controlled Drugs.

 

HSA will conduct audits to monitor the e-pharmacy services to ensure compliance with regulatory requirements and will publish alerts on non-compliant or illegal e-pharmacy operators.

 

Refer to Guidance Notes on Supply of Registered Therapeutic Products through e-pharmacy, including the Application Checklist, for more information to help you in your planning and submission.
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