Health Products (Therapeutic Products) Regulations 2016

is written and signed by a qualified practitioner or collaborative prescribing practitioner; and

contains all of the following particulars:

the date of the prescription;

the name and address of the qualified practitioner or collaborative prescribing practitioner giving the prescription;

the name, identity card or other identification document number, and contact details, of the patient to whom the prescription relates;

the name and total amount of the prescribed therapeutic product to be supplied to, and the dose to be taken by, the patient;

where the qualified practitioner or collaborative prescribing practitioner giving the prescription intends for the prescription to be repeated, an indication of the number of times, and the time period between which, the prescribed therapeutic product may be supplied;

where the prescription is given by a dentist, a declaration by the dentist that the prescription is “for dental treatment only”.

the applicant is able to provide and maintain, or ensure the provision and maintenance of, such staff, premises, equipment and facilities for the handling and storage of the therapeutic product as are necessary to prevent the deterioration of the therapeutic product while it is in the applicant’s ownership, possession or control;

the therapeutic product —

is imported on behalf of a specified healthcare service licensee pursuant to a valid prescription given by a qualified practitioner (who is a personnel of the specified healthcare service licensee) for the use of the qualified practitioner’s patient;

is intended to be supplied solely for the purpose of scientific education or research and development, or for a non-clinical purpose;

is imported solely for the purpose of export;

is intended to be supplied for use on a ship, and the therapeutic product is one that is 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. S 181/2014) or any other written law, for the treatment of persons on board that ship;

is intended to be supplied for use on an aircraft, and the therapeutic product forms 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;

is authorised for import by the registrant of the therapeutic product; or

is in all respects the same as a registered therapeutic product, the registrant of which has not authorised the applicant to import that registered therapeutic product; and

the applicant is able to comply with the requirements in the Authority’s Guidance Notes on Good Distribution Practice for importers set out on the Authority’s website if the therapeutic product is imported in accordance with sub‑paragraph (b)(i), (vi) and (vii).

is a preparation containing an active ingredient specified in Part 1 of the Second Schedule;

is within any class of therapeutic products specified in Part 2 of that Schedule; or

is a preparation containing an active ingredient specified in Part 3 of that Schedule.

before the supply, be satisfied that the recipient carries on the trade, business or profession stated in the order and that such trade, business or profession is one in which the therapeutic product is used;

at the time of the supply, ensure that there is an order in writing, signed by the recipient, stating the recipient’s name and address, trade, business or profession, and the name and total quantity of the therapeutic product supplied; and

after the supply, insert in the appropriate entry in the record of supply prescribed by regulation 32(2)(b) a reference number by which the order can be identified.

the supply is made at or from a licensed retail pharmacy in accordance with regulation 3(1) of the Health Products (Licensing of Retail Pharmacies) Regulations 2016 (G.N. No. S 330/2016);

the supply is made by a healthcare service licensee to a patient of the healthcare service licensee, and is in accordance with the written instructions of a qualified practitioner or collaborative prescribing practitioner who is a personnel of the healthcare service licensee; or

the following requirements are satisfied:

the person is a qualified practitioner or collaborative prescribing practitioner, or a person acting in accordance with the oral or written instructions of a qualified practitioner or collaborative prescribing practitioner;

the supply is made to a patient under the care of the qualified practitioner or collaborative prescribing practitioner.

the date of the supply;

the name, identity card or other identification document number, and contact details, of the person to whom the pharmacy-only medicine is supplied;

the name, strength and total amount of pharmacy-only medicine to be supplied;

the dosage, and the frequency and purpose of the treatment for which the supply is made.

where codeine cough preparations are supplied to the individual in liquid form only — an aggregate amount of 240 ml of codeine cough preparations;

where codeine cough preparations are supplied to the individual in solid form only or in both liquid and solid forms — an aggregate amount of 355 mg of codeine (calculated as codeine base) contained in the codeine cough preparations supplied.

the date of supply;

the name, identity card or other identification document number, and contact details, of the person to whom the therapeutic product is supplied;

the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name, and the total amount supplied;

if the therapeutic product is supplied by a qualified pharmacist or a person acting under the supervision of a qualified pharmacist, or at or from a licensed retail pharmacy, the name and address of the qualified practitioner or collaborative prescribing practitioner who signed the prescription.

the name of the person to whom the therapeutic product is to be administered;

where the product is supplied or dispensed —

at a licensed retail pharmacy — the name, address and any identification number or logo of the licensed retail pharmacy;

at any approved permanent premises by a healthcare service licensee under a business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee;

at any temporary premises or approved conveyance by a healthcare service licensee under a business name —

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

in any other case — the business name, address and any identification number or logo of the healthcare service licensee; or

by a healthcare service licensee using a remote service kiosk or by delivery under a business name —

if the healthcare service licensee is also approved under the Healthcare Services Act 2020 to provide the licensable healthcare service at any permanent premises under that business name — the business name, address of the approved permanent premises and any identification number or logo of the healthcare service licensee; or

in any other case — the business name, address and any identification number or logo of the healthcare service licensee;

the date that the therapeutic product is dispensed;

the directions for use of the therapeutic product;

the name of the therapeutic product, being either the proprietary name or the appropriate non-proprietary name;

where the appropriate non-proprietary name is included on the label, the appropriate quantitative particulars of any active ingredient of the therapeutic product.

where the qualified practitioner or collaborative prescribing practitioner giving the prescription does not specify that the prescription is to be repeated, the relevant person dispensing the prescription-only medicine must —

when dispensing, mark the prescription in a manner so as to permanently attach the person’s name and address and the dispensing date to the prescription; and

retain the prescription for a period of at least 2 years after dispensing; or

where the qualified practitioner or collaborative prescribing practitioner giving the prescription specifies that the prescription is to be repeated, the relevant person dispensing the prescription-only medicine —

must not dispense more than the total number of times specified on the prescription;

when dispensing, must mark the prescription in such a manner as to permanently attach the person’s name and address and the dispensing date to the prescription; and

must retain the prescription for a period of at least 2 years after dispensing for the last time.

a qualified practitioner or collaborative prescribing practitioner, or a person acting under the supervision of a qualified practitioner or collaborative prescribing practitioner; or

a qualified pharmacist or a person acting under the supervision of a qualified pharmacist.

a trade description which is false or misleading must not be applied to the therapeutic product;

a trade description which explicitly or implicitly suggests that the supply or use of the therapeutic product is promoted or endorsed by the Authority, the Ministry of Health or the Health Promotion Board must not be applied to the therapeutic product.

it contains any false statement or information concerning the therapeutic product; or

it is likely to create an erroneous impression regarding the formulation, composition, quality, safety, efficacy or uses of the therapeutic product.

affixes or annexes the trade description to, or in any manner marks it on or incorporates it in —

the therapeutic product; or

any thing in or on the therapeutic product or with which the therapeutic product is supplied;

places the therapeutic product in, on or with any thing which the trade description has been affixed or annexed to, marked on or incorporated in; or

makes any oral or written statement of the trade description, or uses the trade description in any other manner, which is likely to be understood as referring to the therapeutic product.

the therapeutic product is supplied pursuant to a request in which the trade description is used; and

it is reasonable in the circumstances to infer that any therapeutic product so supplied will correspond to that trade description.

the name of the therapeutic product, being the proprietary name and the appropriate non-proprietary name;

the appropriate quantitative particulars of any active ingredient of the therapeutic product;

an appropriate control number, such as a serial number, batch number or lot number;

the expiry date of the therapeutic product;

where the therapeutic product is registered, the registration number assigned to the registered therapeutic product by the Authority.

must be provided in English; and

must be legible and indelible.

to stop disseminating, publishing or using the trade description with immediate effect;

to stop applying the trade description to the therapeutic product, or to stop supplying the therapeutic product applied with the trade description, with immediate effect;

to take such measures as may be reasonable and necessary in the circumstances to discontinue or remove any trade description that may already have been applied, disseminated, published or used;

to apply, disseminate or publish a corrective trade description in such manner and containing such information as the Authority may require.

to stop supplying the therapeutic product with immediate effect; or

to take such measures as may be reasonable and necessary in the circumstances to ensure that the therapeutic product is only supplied with the required information.

whether any of the following patents under the Patents Act 1994 is in force in respect of the therapeutic product as described in the application for registration:

a patent containing a claim for an active ingredient of that therapeutic product;

a patent containing a claim for a formulation or composition of that therapeutic product;

a patent containing a claim for the use of an active ingredient in the manufacture of that therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use;

if one or more patents mentioned in sub-paragraph (a) are in force in respect of the therapeutic product as described in the application for registration —

whether the applicant for the registration of the therapeutic product is the proprietor of the patent or those patents; and

if the applicant is not the proprietor of the patent or any of the patents —

whether the proprietor has consented to or has acquiesced in the grant of the registration of the therapeutic product to the applicant; or

whether the patent or any of the patents is invalid or will not be infringed by the doing of the act for which the registration of the therapeutic product is sought.

whether one or more patents under the Patents Act 1994 mentioned in paragraph (1)(a) are in force in respect of the therapeutic product; and

whether the applicant is the proprietor of the patent or those patents.

the name and address of the proprietor of the patent;

whether —

the proprietor has consented to or has acquiesced in the grant of the registration of the therapeutic product by the applicant; or

in the opinion of the applicant and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the registration of the therapeutic product is sought; and

such other information as the Authority may require in any particular case.

the applicant has declared that, in the applicant’s opinion and to the best of the applicant’s belief, the patent is invalid or will not be infringed by the doing of the act for which the registration is sought; or

the Authority considers it appropriate in any particular case for the applicant to do so.

apply to a court for —

an order restraining the act for which the registration of the therapeutic product is sought; or

a declaration that the patent is valid and will be infringed by the doing of the act for which the registration of the therapeutic product is sought; and

furnish the following to the Authority:

a written notice stating that an application under sub-paragraph (a) has been made;

evidence of the application made under sub-paragraph (a);

a declaration by the proprietor in the form specified on the Authority’s website that the application made under sub-paragraph (a) relates to a patent mentioned in paragraph (1)(a) that is in force in respect of the therapeutic product that is the subject of an application for registration.

a process patent, other than a process patent that contains a claim for the use of an active ingredient in the manufacture of a therapeutic product for a specific therapeutic, preventive, palliative or diagnostic use;

a patent that contains only claims relating to packaging;

a patent that contains only claims relating to metabolites;

a patent that contains only claims relating to intermediates.

that —

a court has determined that the doing of an act authorised by the registration infringes a patent under the Patents Act 1994; or

a court has determined that the declaration made under regulation 23(2) contains a statement that is false or misleading in a material particular or omits to disclose any matter that is material to the application; and

that the determination mentioned in sub-paragraph (a)(i) or (ii) is final.

must take reasonable steps to ensure that the confidential supporting information is kept confidential to the Authority; and

must not use that confidential supporting information for the purpose of determining whether to grant any other application to register a therapeutic product.

disclose that confidential supporting information, or use that confidential supporting information for the purpose of determining whether to grant any other application to register a therapeutic product —

with the consent of the applicant who made the application to which the confidential supporting information relates; or

if that disclosure or use is, in the opinion of the Authority, necessary to protect the health or safety of members of the public;

disclose that confidential supporting information to a Government department or statutory body for the purpose of facilitating or assisting such Government department or statutory body in carrying out its duties if, in the opinion of the Authority, the Government department or statutory body, as the case may be, will take reasonable steps to ensure the confidential supporting information is kept confidential; or

disclose that confidential supporting information to, if so requested by, any one or more of the following:

the World Health Organization;

the Food and Agriculture Organization of the United Nations;

any regulatory agency of a country that is a party to the Agreement establishing the World Trade Organization adopted at Marrakesh on 15 April 1994;

any Advisory Committee established under section 10 of the Act.

that applicant —

has notified the Authority in writing that P may grant that consent; and

has not notified the Authority in writing that P’s authority to grant that consent has been withdrawn; or

that applicant’s rights in respect of the relevant confidential supporting information have been transferred to P and the applicant or P has notified the Authority in writing of the transfer.

any premises that are used for the manufacture, supply or storage of therapeutic products; and

any conveyance that is being used for the transport of therapeutic products.

require any person having possession or control of any therapeutic product that is found during the inspection to furnish, without charge, a sample of such therapeutic product for the Authority’s examination; and

take or cause to be taken any photograph of —

the premises or conveyance mentioned in paragraph (1); or

any property or material found on the premises or in the conveyance.

such information relating to the therapeutic product and its manufacture or assembly as the Authority may specify on the Authority’s website or, if the manufacturer is the holder of a manufacturer’s licence, in the manufacturer’s licence; and

the manufacture of each batch of the therapeutic product and of the tests carried out on each of such batch, in the manner specified on the Authority’s website or in the relevant licence issued by the Authority (if applicable).

one year after the expiry date of the therapeutic product;

5 years after the date of manufacture of the therapeutic product.

a licensee or registrant of a therapeutic product; or

the supplier of a therapeutic product in accordance with regulation 47, 49, 51, 58(1)(b), (c) or (d) or 60A(3) or (4).

if P is not the manufacturer of the therapeutic product, maintain a record of every receipt by P of the therapeutic product;

maintain a record of every supply by P of the therapeutic product; and

produce for inspection by the Authority or an enforcement officer the record of every receipt or supply as and when required by the Authority or enforcement officer.

contains, in relation to each receipt by P of the therapeutic product, all of the following information:

the proprietary name or appropriate non‑proprietary name of the therapeutic product, if the therapeutic product is supplied by a manufacturer, importer or wholesaler, as the case may be;

the date on which the therapeutic product is received;

the name and address of the person from whom the therapeutic product is received;

the quantity of the therapeutic product received;

the identification number (including the control number, lot number, batch number or serial number) of the therapeutic product received;

contains, in relation to each supply by P of the therapeutic product, all of the following information:

the proprietary name or appropriate non‑proprietary name of the therapeutic product;

the date on which the therapeutic product is supplied;

the name and address of the person to whom the therapeutic product is supplied;

the quantity of the therapeutic product supplied;

the identification number (including the control number, lot number, batch number or serial number) of the therapeutic product supplied; and

is retained for at least 2 years after the date on which the therapeutic product is so supplied to another person.

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; and

produce such record for inspection by the Authority or an enforcement officer as and when required by the Authority or enforcement officer.

contains all of the following information:

the proprietary name or appropriate non‑proprietary name of the therapeutic product which is defective or of which an adverse effect has arisen from its use;

the date on which the person first became aware of the event or occurrence;

the identification number or mark (including the control number, lot number, batch number or serial number) of the therapeutic product;

the nature of the defect or adverse effect;

any other information that the Authority may specify in writing; and

is retained for at least 2 years after the expiry date of the therapeutic product.

if the defect represents a serious threat to persons or public health, within 48 hours; or

in all other cases, within 15 days,after the manufacturer, importer, supplier or registrant, as the case may be, first receives notice of the defect.

may result in a person’s death;

may threaten a person’s life;

results in a person being hospitalised or prolongs a person’s existing stay in hospital;

results in a person’s persistent or significant disability or incapacity;

results in a congenital anomaly or birth defect; or

is judged to be medically important even though the effect might not be immediately life-threatening or result in death or hospitalisation, but may jeopardise the person’s health or may require intervention to prevent the person’s death or one of the other outcomes mentioned in sub-paragraphs (c), (d) and (e).

investigate the matter occasioning the recall of the therapeutic product and provide a report of the findings of the investigation;

take such other measures as the Authority thinks necessary.

the responsible person has adequate knowledge of the activities to be carried out and of the procedures to be performed under the licence;

the responsible person has relevant working experience relating to those activities and procedures;

in the case of a manufacturer’s licence, the responsible person named in the licence has practical experience in production supervision or in testing and checking to ensure the quality of therapeutic products or related health products;

in the case of an importer’s licence or wholesaler’s licence for the import or supply of any therapeutic product that is not registered at the request of a qualified practitioner for the use of the qualified practitioner’s patient, the responsible person named in the licence is a qualified pharmacist or such other person as the Authority may approve;

in the case of an importer’s licence or a wholesaler’s licence for the import or supply by wholesale of prescription-only medicine or pharmacy-only medicine, the responsible person named in the licence is a qualified pharmacist or such other person as the Authority may approve; and

at any time, there is at least one responsible person who is contactable by the Authority by way of a mobile telephone number or an email address.

any change or proposed change to any particulars furnished by the licensee to the Authority in relation to the application for the licensee’s licence; and

any change or proposed change that significantly affects the activities of the licensee that are authorised by that licence.