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Regulatory Guidelines and Standards
Under the Medicines (Registration of Pharmacies) Regulations, a pharmacy must be registered with the Health Sciences Authority (HSA). The registered pharmacy must be under the control and management of a full time qualified pharmacist registered with the Singapore Pharmacy Council. The pharmacy shall provide at least 35 hours dispensing service per week.The pharmacist shall hold a Form A Poisons Licence to sell medicinal products containing scheduled poisons by way of wholesale dealing (include export sales, and supply to medical clinics & ships) at a registered pharmacy.
Prior to the issuance of a Certificate of Registration of a Pharmacy, a pre-approval audit of the pharmacy will be conducted by pharmacy auditors from HSA. During the audit, the pharmacy will be assessed for compliance with legal and general pharmacy dispensing requirements including the availability of suitable dispensing equipment, appropriate facilities for storage, safekeeping and handling of medicinal products, adequate professional reference books and a proper system for maintenance of records, procedures and other documentation relating to dispensing operations.
In cases where a new pharmacy is an additional outlet of a chain pharmacy (with at least one outlet already registered with HSA), the new pharmacy may be eligible for a simplified registration scheme. Under this scheme, a Certificate of Registration can be issued before an onsite audit is conducted if this new pharmacy is essentially the same as the other registered outlet (s) with respect to legal and general pharmacy dispensing requirements. Pharmacies intending to provide telepharmacy and compounding (other than simple dissolving, diluting or mixing of medicinal products) services are not eligible for the simplified scheme.
Prior to the issuance of a Certificate of Registration of a Pharmacy, a pre-approval audit of the pharmacy will be conducted by pharmacy auditors from HSA. During the audit, the pharmacy will be assessed for compliance with legal and general pharmacy dispensing requirements including the availability of suitable dispensing equipment, appropriate facilities for storage, safekeeping and handling of medicinal products, adequate professional reference books and a proper system for maintenance of records, procedures and other documentation relating to dispensing operations.
In cases where a new pharmacy is an additional outlet of a chain pharmacy (with at least one outlet already registered with HSA), the new pharmacy may be eligible for a simplified registration scheme. Under this scheme, a Certificate of Registration can be issued before an onsite audit is conducted if this new pharmacy is essentially the same as the other registered outlet (s) with respect to legal and general pharmacy dispensing requirements. Pharmacies intending to provide telepharmacy and compounding (other than simple dissolving, diluting or mixing of medicinal products) services are not eligible for the simplified scheme.
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