The Medicines (Gonadotrophin-Releasing Hormone Analogues) (Restrictions on Private Sales and Supplies) Order 2024
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Change 1
2 Interpretation
(1) In this Order— “2012 Regulations” means the Human Medicines Regulations 2012; “approved UK prescriber” means an authorised prescriber who is an appropriate practitioner in relation to any prescription only medicine by virtue of regulation 214(3)(a), (c), (d) or (e) of the 2012 Regulations (sale or supply of prescription only medicines); “authorised prescriber” means any person who is an appropriate practitioner for the purposes of regulation 214 of the 2012 Regulations (subject to any limits on their prescribing rights included in that regulation); “clinical trial” has the meaning given in regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (interpretation); “current national identity document” means a document that is a current national identity document for the purposes of the rules under section 3(2) of the Immigration Act 1971 (general provisions for regulation and control); “gonadotrophin-releasing hormone analogue” or “GnRH analogue” means a medicinal product that consists of or contains buserelin, gonadorelin, goserelin, leuprorelin acetate, nafarelin or triptorelin; “licensing authority” has the meaning given in regulation 6(2) of the 2012 Regulations (the licensing authority and the Ministers); “NHS prescription” means an order for a medicinal product which is in the form of a prescription or direction and which is issued by an authorised prescriber as part of arrangements for the provision of services as part of— in England, the health service as defined by section 275(1) of the National Health Service Act 2006 (interpretation); in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978 (interpretation and construction); in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006 (interpretation); in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (Department’s general duty); “private prescription” means an order for a medicinal product which is in the form of a prescription or direction which is not a NHS prescription (whether or not it would otherwise be considered a private prescription); “sale” means sale by retail (and “selling” has a corresponding meaning); “specified document” has the meaning given in rule 37(1H) of the election rules in Schedule 1 to the Representation of the People Act 1983 (Parliamentary election rules – voting procedure and voter identification requirements); “standard private prescription” means a private prescription which— is a prescription rather than a direction; and is or purports to be in accordance with the requirements of regulation 217, 218, 219 or 219A of the 2012 Regulations (which relate to requirements for paper and electronic prescriptions); “UK birth certificate” means a certified copy of a United Kingdom birth register entry or a valid certificate of birth compiled from such an entry. (2) For the purposes of this Order, treatment is treatment in respect of gender dysphoria, gender incongruence or a combination or both if it is, viewed objectively, treatment in respect of those conditions, as gender dysphoria and gender incongruence are ordinarily understood as part of medical practice in the United Kingdom.
2 Interpretation
(1) In this Order— “2012 Regulations” means the Human Medicines Regulations 2012; “approved UK prescriber” means an authorised prescriber who is an appropriate practitioner in relation to any prescription only medicine by virtue of regulation 214(3)(a), (c), (d) or (e) of the 2012 Regulations (sale or supply of prescription only medicines); “authorised prescriber” means any person who is an appropriate practitioner for the purposes of regulation 214 of the 2012 Regulations (subject to any limits on their prescribing rights included in that regulation); “clinical trial” has the meaning given in regulation 2(1) of the Medicines for Human Use (Clinical Trials) Regulations 2004 (interpretation); “current national identity document” means a document that is a current national identity document for the purposes of the rules under section 3(2) of the Immigration Act 1971 (general provisions for regulation and control); “gonadotrophin-releasing hormone analogue” or “GnRH analogue” means a medicinal product that consists of or contains buserelin, gonadorelin, goserelin, leuprorelin acetate, nafarelin or triptorelin; “licensing authority” has the meaning given in regulation 6(2) of the 2012 Regulations (the licensing authority and the Ministers); “NHS prescription” means an order for a medicinal product which is in the form of a prescription or direction and which is issued by an authorised prescriber as part of arrangements for the provision of services as part of— in England, the health service as defined by section 275(1) of the National Health Service Act 2006 (interpretation); in Scotland, the health service as defined by section 108(1) of the National Health Service (Scotland) Act 1978 (interpretation and construction); in Wales, the health service as defined by section 206(1) of the National Health Service (Wales) Act 2006 (interpretation); in Northern Ireland, the system of health and social care promoted under section 2(1) of the Health and Social Care (Reform) Act (Northern Ireland) 2009 (Department’s general duty); “private prescription” means an order for a medicinal product which is in the form of a prescription or direction which is not a NHS prescription (whether or not it would otherwise be considered a private prescription); “sale” means sale by retail (and “selling” has a corresponding meaning); “specified document” has the meaning given in rule 37(1H) of the election rules in Schedule 1 to the Representation of the People Act 1983 (Parliamentary election rules – voting procedure and voter identification requirements); “standard private prescription” means a private prescription which— is a prescription rather than a direction; and is or purports to be in accordance with the requirements of regulation 217, 218, 219 or 219A of the 2012 Regulations (which relate to requirements for paper and electronic prescriptions); “UK birth certificate” means a certified copy of a United Kingdom birth register entry or a valid certificate of birth compiled from such an entry. (2) For the purposes of this Order, treatment is treatment in respect of gender dysphoria, gender incongruence or a combination or both if it is, viewed objectively, treatment in respect of those conditions, as gender dysphoria and gender incongruence are ordinarily understood as part of medical practice in the United Kingdom.
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