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) In these Regulations “medicinal product” means—

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

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

(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—

(a) whole human blood; or

(b) 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 "administer" as follows:

“administer” means administer to a human being—

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

(b) 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Although Note 12 refers to section 132 of the Medicines Act 1968 in defining the word “substance”, theis has now been replaced by Regulation 8 of The Human Medicines Regulations 2012, as follows:

“substance” means any matter regardless of its origins and includes—

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

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

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

(d) 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.