1. The medicinal product—

(a) must be suitable for use under the supervision of a general medical practitioner or other relevant health professional and not be restricted to hospital or medical specialist use,

(b) subject to paragraph 2, must not be advertised or promoted directly to the public,

(c) must not be for the purpose of obtaining a cosmetic effect,

(d) F3[subject to paragraph 2,] must be such that it is ordinarily supplied to the public only on foot of a prescription, and

F4[(e) must have an authorisation referred to in paragraph (a) or (b)(i), (ii), (iii) or (iv) of the definition of ‘authorisation holder’ in section 2(1).]

2. The Executive may disapply the criterion referred to in paragraph 1(b) F5[or (d)] in the case of a particular medicinal product if it is satisfied that to disapply that criterion in that case is in the interests of—

(a) patient safety, or

(b) public health.

1. The medical device, foodstuff for a particular nutritional use or dietary food for a special medical purpose—

(a) must be suitable for use under the supervision of a general medical practitioner or other relevant health professional and not be restricted to hospital or medical specialist use,

(b) subject to paragraph 2, must not be advertised or promoted to the public, and

(c) must not be for the purpose of obtaining a cosmetic effect.

2. The Executive may disapply the criterion referred to in paragraph 1(b) in the case of a particular medical device, foodstuff for a particular nutritional use or dietary food for a special medical purpose if it is satisfied that to disapply that criterion in that case is in the interests of—

(a) patient safety, or

(b) public health.

The Executive shall have regard to—

(a) the health needs of the public,

(b) the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services,

(c) the availability and suitability of items for supply or reimbursement, or both, under section 59 of the Act of 1970,

(d) the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks,

(e) the potential or actual budget impact of the item or listed item,

(f) the clinical need for the item or listed item,

(g) the appropriate level of clinical supervision required in relation to the item to ensure patient safety,

(h) the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies), and

(i) the resources available to the Executive.