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The Health Service Products (Provision and Disclosure of Information) Regulations 2018

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1.—(1) In these Regulations—

“the 1978 Act” means the National Health Service (Scotland) Act 1978(1);

“the 2006 Act” means the National Health Service Act 2006(2);

“the 2006 Wales Act” means the National Health Service (Wales) Act 2006(3);

“the 1972 Order” means the Health and Personal Social Services (Northern Ireland) Order 1972(4);

“the 2000 Regulations” means the Health Service Medicines (Price Control Appeals) Regulations 2000(5);

“the 2012 Regulations” means the Human Medicines Regulations 2012(6);

“common name”, in relation to a medicinal product, means—

(a)

the non-proprietary name of the medicinal product, or

(b)

if one does not exist, the product’s usual common name;

“compliance notice” has the meaning given in regulation 31(1);

“discount” means a trade or other discount (however named) and includes a settlement discount or a rebate;

“the Drug Tariff (England)” means the publication known as the Drug Tariff and published by the Secretary of State under regulation 89 of the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013(7);

“the Drug Tariff (Northern Ireland)” means the publication known as the Drug Tariff and published by the Department of Health under regulation 9 of the Pharmaceutical Services Regulations (Northern Ireland) 1997(8);

“the Drug Tariff (Scotland)” means the Drug Tariff within the meaning given in section 27A of the 1978 Act;

“the Drug Tariff (Wales)” means the publication known as the Drug Tariff (“Tariff Cyffuriau”) and published under regulation 41 of the National Health Service (Pharmaceutical Services) (Wales) Regulations 2013(9);

“excipient”, in relation to a medicinal product, means an ingredient of the product which is not an active ingredient and includes (but is not limited to)—

(a)

alcohol,

(b)

a colouring,

(c)

a flavouring,

(d)

gelatine,

(e)

gluten,

(f)

lactose,

(g)

a preservative, and

(h)

sugar;

“excipient formulation” means a formulation in which a medicinal product is manufactured so that it may be supplied—

(a)

as being free from a particular excipient,

(b)

as containing a reduced amount of a particular excipient, or

(c)

as containing a particular excipient,

and includes, for example, a formulation which is lactose free or which is given a specific flavour;

“financial year”—

(a)

in relation to a UK primary medical services provider, Health Service chemist or an NHS hospital purchaser, has the meaning given in section 275 of the 2006 Act;

(b)

in relation to any other UK producer, has the meaning given in section 390 of the Companies Act 2006(10);

“Health Service chemist” has the meaning given in paragraph 3(7);

“HSCIC” means the Health and Social Care Information Centre(11);

“importer” means a person—

(a)

who is not a medicines wholesaler, but

(b)

who imports health service medicines into the United Kingdom and supplies those medicines;

“imported special health service medicine” has the meaning given in regulation 10(1);

“made special health service medicine” has the meaning given in regulation 10(1);

“manufacturer’s licence” has the meaning given in regulation 17 of the 2012 Regulations;

“maximum pack size”—

(a)

in relation a presentation in tablet form, means a pack size of 120 tablets;

(b)

in relation to a presentation in capsule form, means a pack size of 120 capsules;

(c)

in relation to a presentation which is a liquid or a topical preparation, means a pack size of 500ml;

“medicines wholesaler” means a person who holds a wholesale dealer’s licence (within the meaning given in regulation 18 of the 2012 Regulations);

“medical supplies wholesaler” has the meaning given in sub-paragraph (2);

“net NHS expenditure” has the meaning given in paragraph 4(2);

“net NHS wholesale income” has the meaning given in paragraph 4(3);

“net purchase amount” has the meaning given in paragraph 4(4);

“net sales income” has the meaning given in paragraph 4(5);

“NHS Digital online gateway”, in relation to information required to be provided to the Secretary of State by, or under, these Regulations, means a service provided on HSCIC’s website for the provision of that information;

“NHS framework contract” has the meaning given in paragraph 5;

“NHS hospital purchaser” means a person who—

(a)

is mentioned in Part 3 of Schedule 1 to the Freedom of Information Act 2000(12) or in Part 4 of Schedule 1 to the Freedom of Information (Scotland) Act 2002(13); and

(b)

is responsible, under the arrangements for managing a hospital that supplies UK health service products, for purchasing those products;

“presentation” has the meaning given in paragraph 2;

“special health service medicine” has the meaning given in regulation 10(1);

“statutory purpose” means the purpose specified in section 264A(3) of the 2006 Act;

“unbranded generic health service medicine” has the meaning given in regulation 6;

“UK primary medical services provider” has the meaning given in paragraph 3(2);

“working day” means a day which is not—

(a)

a Saturday or a Sunday,

(b)

Christmas Day,

(c)

Good Friday, or

(d)

a bank holiday in any part of the United Kingdom under the Banking and Financial Dealings Act 1971(14).

(2) “Medical supplies wholesaler” means a UK producer who distributes UK health service products which are not health service medicines by way of wholesale dealing.

(3) For the purposes of these Regulations, a reference to the distribution by way of wholesale dealing of UK health service products is—

(a)in the case of health service medicines to be construed in accordance with regulation 18(4) and (5) of the 2012 Regulations;

(b)in the case of any other health service products to be construed in accordance with sub-paragraph (4).

(4) A UK producer distributes a product (which is not a health service medicine) by way of wholesale dealing if the producer supplies the product to another person who buys it for the purpose of supplying it.

(6)

S.I. 2012/1916, amended by S.I. 2013/1855, 2016/186 and 2017/715; there are other amending instruments but none is relevant.

(7)

S.I. 2013/349, to which there are amendments not relevant to these Regulations.

(9)

S.I. 2013/898 (W. 102), to which there are amendments not relevant to these Regulations.

(11)

The Health and Social Care Information Centre was established by section 252 of the Health and Social Care Act 2012 (c. 7).

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