PART 7 | EXCEPTIONS — MANUFACTURE, IMPORT AND WHOLESALE OF THERAPEUTIC PRODUCTS WITHOUT LICENCE |
| Division 1 — Specified healthcare service licensees |
[S 811/2023 wef 18/12/2023] [S 436/2023 wef 26/06/2023] | Compounding of therapeutic products at approved permanent premises, etc., of specified healthcare service licensees without manufacturer’s licence |
46.—(1) A specified healthcare service licensee may compound a therapeutic product without holding a manufacturer’s licence, if —| (a) | the therapeutic product is compounded from an active ingredient or another therapeutic product; | | (b) | the final form or packaging of the compounded therapeutic product is not available or marketed for commercial supply in Singapore; | | (c) | the compounding is carried out —| (i) | [Deleted by S 811/2023 wef 18/12/2023] | | (ii) | where the therapeutic product is compounded by a specified healthcare service licensee —| (A) | at any approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee or, in the case of a sterile therapeutic product, at a practice setting within the approved permanent premises, temporary premises or approved conveyance where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented; and | | (B) | by or under the supervision of a qualified practitioner or a qualified pharmacist who is a personnel of the specified healthcare service licensee; and [S 436/2023 wef 26/06/2023] |
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| | (d) | an appropriate expiry date, either in accordance with standards set out in any specified publication or supported by a stability study, accompanies the compounded therapeutic product. [S 436/2023 wef 26/06/2023] |
[S 811/2023 wef 18/12/2023] (2) In addition to the requirements in paragraph (1), the therapeutic product must be compounded in accordance with the written instructions of a qualified practitioner, if —| (a) | the therapeutic product is for the use of any patient under the care of the qualified practitioner; and | | (b) | the therapeutic product contains an active ingredient specified in Part 1 of the Second Schedule or is within any class of therapeutic products specified in Part 2 of that Schedule. |
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| (3) Paragraph (2) does not apply if the compounding consists only of repacking for the purpose of dispensing the therapeutic product. |
(4) It does not matter whether the patient mentioned in paragraph (2) is or is not a patient —| (a) | [Deleted by S 811/2023 wef 18/12/2023] | | (b) | at the approved permanent premises, temporary premises or approved conveyance of the specified healthcare service licensee at which the compounding is carried out. [S 436/2023 wef 26/06/2023] |
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(5) A therapeutic product compounded under paragraph (1) by a specified healthcare service licensee who is authorised to provide an outpatient dental service, outpatient medical service or outpatient renal dialysis service at any approved permanent premises, temporary premises or approved conveyance, must not be supplied to any of the following unless the approval of the Authority has been obtained for the supply:| (a) | [Deleted by S 811/2023 wef 18/12/2023] | | (b) | any approved permanent premises of the specified healthcare service licensee (other than the approved permanent premises at which the therapeutic product was compounded); | | (c) | any approved permanent premises of another specified healthcare service licensee. [S 436/2023 wef 26/06/2023] |
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| (6) An application for the Authority’s approval under paragraph (5) must be made in the form and manner specified on the Authority’s website. |
| (7) For the purposes of section 45 of the Act, a specified healthcare service licensee who compounds a therapeutic product under paragraph (1) must ensure that the therapeutic product is compounded in accordance with the requirements in paragraph (1)(c) and (d), and, if applicable, paragraph (2). [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] |
| (8) A person who fails to comply with paragraph (7) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both. |
| (9) For the purposes of section 41 of the Act, the Authority may require a specified healthcare service licensee who compounds a therapeutic product under paragraph (1) to furnish records of any stability study mentioned in paragraph (1)(d). [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] |
[S 811/2023 wef 18/12/2023] |
| Transfer of therapeutic products by specified healthcare service licensees without wholesaler’s licence |
47.—(1) [Deleted by S 811/2023 wef 18/12/2023](2) A specified healthcare service licensee (other than an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis licensee) (called in this paragraph A) may, in the case of a therapeutic product compounded by A under regulation 46(1) at any approved permanent premises, temporary premises or approved conveyance, transfer A’s stock of the therapeutic product at the approved permanent premises, temporary premises or approved conveyance (as the case may be) to any of the following without holding a wholesaler’s licence:| (a) | [Deleted by S 811/2023 wef 18/12/2023] | | (b) | another approved permanent premises, temporary premises or approved conveyance of A; | | (c) | any approved permanent premises, temporary premises or approved conveyance of another specified healthcare service licensee. |
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(3) A specified healthcare service licensee who is an outpatient dental service licensee, outpatient medical service licensee or outpatient renal dialysis service licensee (called in this paragraph B) may, in the case of a therapeutic product compounded by B under regulation 46(1) at any approved permanent premises, temporary premises or approved conveyance, transfer B’s stock of the therapeutic product at the approved permanent premises, temporary premises or approved conveyance (as the case may be) to any of the following without holding a wholesaler’s licence, if the approval of the Authority has been obtained under regulation 46(5) for the transfer:| (a) | [Deleted by S 811/2023 wef 18/12/2023] | | (b) | any approved permanent premises of B; | | (c) | any approved permanent premises of another specified healthcare service licensee. |
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| (4) A specified healthcare service licensee (called in this paragraph C) may, in the case of a therapeutic product that is imported by C under regulation 51 or imported by a licensed importer under regulation 58(1)(f), transfer C’s stock of the therapeutic product to another specified healthcare service licensee without holding a wholesaler’s licence. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] |
[S 811/2023 wef 18/12/2023] |
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| Division 2 — Licensed retail pharmacies |
| Compounding of therapeutic products at licensed retail pharmacies without manufacturer’s licence |
48.—(1) The holder of a pharmacy licence relating to a licensed retail pharmacy may compound a therapeutic product without holding a manufacturer’s licence, if —| (a) | the therapeutic product is compounded from an active ingredient or another therapeutic product; | | (b) | the final form or packaging of the compounded therapeutic product is not available or marketed for commercial supply in Singapore; | | (c) | the compounding is carried out —| (i) | at the licensed retail pharmacy; | | (ii) | by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist; | | (iii) | for the purposes and under the conditions described in paragraph (2), (3) or (4), whichever is applicable; and | | (iv) | in the case of a sterile therapeutic product, at premises where standards established for the operation of clean rooms and the preparation of sterile products are in place and properly documented; and |
| | (d) | an appropriate expiry date, either in accordance with standards set out in any specified publication or supported by a stability study, accompanies the compounded therapeutic product. |
(2) If the therapeutic product is to be compounded for the use of any patient under the care of a qualified practitioner and it contains an active ingredient specified in Part 1 of the Second Schedule or is within any class of therapeutic products specified in Part 2 of that Schedule, it must be compounded in accordance with —| (a) | a valid prescription given by the qualified practitioner; or | | (b) | the written instructions of the qualified practitioner, if the qualified practitioner is a personnel of a specified healthcare service licensee. [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] |
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| (3) Paragraph (2) does not apply if the compounding consists only of repacking for the purpose of dispensing the therapeutic product. |
(4) If the therapeutic product is to be compounded for the purpose of supplying for use on a ship, the therapeutic product must —| (a) | be required to be carried on board the ship under the Merchant Shipping (Medical Stores) Regulations (Rg 3), the Merchant Shipping (Maritime Labour Convention) (Medicines and Medical Equipment) Regulations 2014 (G.N. No. 181/2014) or any other written law, for the treatment of persons on board that ship; and [S 436/2023 wef 31/12/2021] | | (b) | be compounded in accordance with such terms and conditions as the Authority may specify in the holder’s pharmacy licence. |
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(5) If the therapeutic product is to be compounded for the purpose of supplying for use on an aircraft, the therapeutic product must —| (a) | form part of the medical supplies required under the Air Navigation Order (O 2) or any other written law, for the treatment of persons on board the aircraft; and [S 436/2023 wef 31/12/2021] | | (b) | be compounded in accordance with such terms and conditions as the Authority may specify in the holder’s pharmacy licence. |
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| (6) For the purposes of section 45 of the Act, any holder of a retail pharmacy licence who compounds a therapeutic product under paragraph (1) must ensure that the therapeutic product is compounded in accordance with the requirements in paragraph (1)(c) and (d), and, if applicable, paragraph (2), (4) or (5). |
| (7) A person who fails to comply with paragraph (6) shall be guilty of an offence and shall be liable on conviction to a fine not exceeding $20,000 or to imprisonment for a term not exceeding 12 months or to both. |
| (8) For the purposes of section 41 of the Act, the Authority may require the holder of a retail pharmacy licence who compounds a therapeutic product under paragraph (1) to furnish records of any stability study mentioned in paragraph (1)(d). |
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| Wholesale supply by holders of pharmacy licences without wholesaler’s licence |
49. The holder of a pharmacy licence may supply a therapeutic product by wholesale without holding a wholesaler’s licence, if the supply —| (a) | is to a healthcare service licensee; [S 436/2023 wef 26/06/2023] [S 811/2023 wef 18/12/2023] | | (b) | is for use on a ship or an aircraft in accordance with the requirements in regulation 5(1)(b)(iv) or (v), respectively; | | (c) | is for the purpose of scientific education or research and development, or for a non‑clinical purpose; | | (d) | is to a Government department or statutory board for the provision of public services; | | (e) | is between licensed retail pharmacy outlets under the same management chain; or | | (f) | consists of the supply of registered therapeutic products to companies outside Singapore for the purpose of any business or trade carried out by those companies. |
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| Division 3 — Named patients |
| Re-labelling of therapeutic products without manufacturer’s licence |
| 50. Without prejudice to regulation 20, a person who imports, or supplies by wholesale, any therapeutic product that is not registered, at the request of a qualified practitioner for the use of the qualified practitioner’s patient, may attach a different label to the therapeutic product without holding a manufacturer’s licence. |
| Import of therapeutic products for patients’ use without importer’s licence |
51.—(1) Subject to paragraph (3), a specified healthcare service licensee may, without holding an importer’s licence, import a therapeutic product that is not registered, if the therapeutic product —| (a) | is required by, and on the written instructions of, a qualified practitioner who is a personnel of the specified healthcare service licensee; and [S 811/2023 wef 18/12/2023] | | (b) | is for the use of the qualified practitioner’s patient. [S 436/2023 wef 26/06/2023] |
[S 811/2023 wef 18/12/2023] | (2) Subject to paragraph (3), the holder of a pharmacy licence may import, without holding an importer’s licence, a therapeutic product that is not registered, if the therapeutic product is intended for the use by a patient of a qualified practitioner pursuant to a valid prescription given by the qualified practitioner. |
(3) The Authority’s prior approval must be obtained for each consignment of a therapeutic product that is imported under paragraph (1) or (2), and the amount imported must not exceed —| (a) | a total dosage of 3 months per patient as recommended by the manufacturer of the therapeutic product; or | | (b) | such other quantity as approved by the Authority. |
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| (4) An application for the Authority’s approval under paragraph (3) must be made in the form and manner specified on the Authority’s website. |
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| Division 4 — Personal imports |
| Import of therapeutic products for personal use without importer’s licence |
52.—(1) Subject to paragraph (2), a person may, without holding an importer’s licence, import for that person’s personal use or for the use of any member of that person’s family a therapeutic product not containing —| (a) | any psychotropic substance; or | | (b) | an amount greater than the amount specified in the second column of the Seventh Schedule of any substance specified in the first column of that Schedule. |
(2) The amount of the therapeutic product imported under paragraph (1) must not exceed a total dosage of 3 months per individual as recommended by —| (a) | the manufacturer of the therapeutic product; or | | (b) | a foreign doctor or dentist by way of a written recommendation, or a qualified practitioner by way of a valid prescription. |
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| Division 5 — Wholesale of therapeutic products for export |
| Wholesale of therapeutic products imported solely for export without wholesaler’s licence |
| 53. Without prejudice to any other provision in these Regulations, a person who holds a valid importer’s licence may supply by wholesale, without a wholesaler’s licence, a therapeutic product that is imported solely for the purpose of export, if the supply is in accordance with such terms and conditions as the Authority may specify in the importer’s licence. |
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| Division 6 — Other exceptions |
| Import of health products by licensed manufacturer without importer’s licence |
| 54. The holder of a manufacturer’s licence may import any health product without holding an importer’s licence, if the health product is required for the purpose of carrying out the manufacture of a therapeutic product in accordance with the conditions of the manufacturer’s licence. |
| Wholesale of self-manufactured therapeutic products without wholesaler’s licence |
| 55. The holder of a manufacturer’s licence may supply by wholesale any therapeutic product manufactured by the holder under the manufacturer’s licence without holding a wholesaler’s licence, if the holder is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the distribution of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the holder’s ownership, possession or control. |
| Wholesale of therapeutic products to ships or aircraft without wholesaler’s licence |
56.—(1) A person may supply by wholesale any therapeutic product to a ship without holding a wholesaler’s licence, if the therapeutic product is not registered and is imported in accordance with the requirements in regulation 5(1)(b)(iv).| (2) A person may supply by wholesale any therapeutic product to an aircraft without holding a wholesaler’s licence, if the therapeutic product is not registered and is imported in accordance with the requirements in regulation 5(1)(b)(v). |
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| Therapeutic products for research or non‑clinical purposes |
57.—(1) A manufacturer’s licence is not required for the manufacture of a therapeutic product, if the manufacture —| (a) | is solely for —| (i) | the purpose of scientific education or research and development; or | | (ii) | a non-clinical purpose; and |
| | (b) | is not for any supply to the public. |
| (2) A manufacturer of a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) is not required to maintain records of manufacture in compliance with regulation 31. |
| (3) A person may supply a therapeutic product for any of the purposes mentioned in paragraph (1)(a)(i) or (ii) without holding a wholesaler’s licence if there is no supply of the therapeutic product to the public. |
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