VCHAR15300 - Medicinal products and substances: The Human Medicines Regulations 2012

Medical purposes

Regulation 2 of The Human Medicines Regulations 2012 defines the term "medical purpose" as follows:

(1)听In these Regulations 鈥渕edicinal product鈥� means鈥�

(a)听any substance or combination of substances presented as having properties of preventing or treating disease in human beings; or

(b)听any substance or combination of substances that may be used by or administered to human beings with a view to鈥�

(i) restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action, or

(ii) making a medical diagnosis.

(2) These Regulations do not apply to鈥�

(a)听whole human blood; or

(b)听any human blood component, other than plasma prepared by a method involving an industrial process.


Administer

Regulation 8 of The Human Medicines Regulations 2012 defines the word听"administer" as follows:

鈥渁dminister鈥� means administer to a human being鈥�

(a)听orally, by injection, or by introduction into the body in any other way; or

(b)听by external application (whether or not by direct application to the body),

and any reference in these Regulations to administering anything is to administering it in its existing state or after it has been dissolved or dispersed in, or diluted or mixed with, a substance used as a vehicle;

Substance

Although Note 12 refers to section 132 of the Medicines Act 1968 in defining the word 鈥渟ubstance鈥�, theis has now been replaced by Regulation 8 of The Human Medicines Regulations 2012, as follows:

鈥渟ubstance鈥� means any matter regardless of its origins and includes鈥�

(a)听human substances (such as human blood and human blood products);

(b)听animal substances (such as micro-organisms, whole animals, parts of organs, animal secretions, toxins, extracts and blood products);

(c)听vegetable substances (such as micro-organisms, plants, parts of plants, vegetable secretions and extracts);

(d)听chemical substances (such as elements, naturally occurring chemical materials and chemical products obtained by chemical change or synthesis); and

(e) gases and vapours;

Note 12 to Group 15, Schedule 8, VAT Act 1994 will be amended in due course.