The Human Medicines Regulations 2012

[F1 Definition of advanced therapy medicinal product etc. U.K.

2A.— (1) In these Regulations, in their application to products for sale or supply in Great Britain only, “advanced therapy medicinal product” means any of the following products—

(a) a gene therapy medicinal product;

(b) a somatic cell therapy medicinal product; or

(c) a tissue engineered product.

(2) A “gene therapy medicinal product” is a biological medicinal product which has the following characteristics—

(a) it contains an active substance which contains or consists of a recombinant nucleic acid used in or administered to human beings with a view to regulating, repairing, replacing, adding or deleting a genetic sequence; and

(b) its therapeutic, prophylactic or diagnostic effect relates directly to the recombinant nucleic acid sequence it contains, or to the product of genetic expression of this sequence.

(3) A vaccine against infectious diseases is not to be treated as a gene therapy medicinal product.

(4) A “somatic cell medicinal product” is a medicinal product which has the following characteristics—

(a) it contains or consists of cells or tissues that—

(i) have been subject to substantial manipulation so that biological characteristics, physiological functions or structural properties relevant for the intended clinical use have been altered, or

(ii) are not intended to be used for the same essential function in the recipient as in the donor; and

(b) it is presented as having properties for, or is used in or administered to human beings with a view to, treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues.

(5) A “tissue engineered product” is a medicinal product which—

(a) contains or consists of engineered cells or tissues; and

(b) is presented as having properties for, or is used in or administered to human beings with a view to, regenerating, repairing or replacing a human tissue.

(6) A tissue engineered product may contain—

(a) cells or tissues of human or animal origin;

(b) viable or non-viable cells or tissues; and

(c) additional substances, including cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices.

(7) A product is not a tissue engineered product if it—

(a) contains or consists exclusively of non-viable human or animal cells or tissues;

(b) does not contain any viable cells or tissues; and

(c) does not act principally by pharmacological, immunological or metabolic action.

(8) Cells or tissues are engineered if they—

(a) have been subject to substantial manipulation, so that biological characteristics, physiological functions or structural properties relevant for the intended regeneration, repair or replacement are achieved; or

(b) are not intended to be used for the same essential function in the recipient as in the donor.

(9) The following manipulations are not substantial manipulations for the purposes of paragraphs (4)(a) and (8)(a)—

(a) cutting;

(b) grinding;

(c) shaping;

(d) centrifugation;

(e) soaking in antibiotic or antimicrobial solutions;

(f) sterilisation;

(g) irradiation;

(h) cell separation, concentration or purification;

(i) filtering;

(j) lyophilisation;

(k) freezing;

(l) cryopreservation; and

(m) vitrification.

(10) In these Regulations, in their application to products for sale or supply in Great Britain only, “combined advanced therapy medicinal product” means an advanced therapy medicinal product—

(a) which incorporates, as an integral part of the product, one or more medical devices or one or more active implantable medical devices; and

(b) the cellular part of which—

(i) contains viable cells or tissues; or

(ii) contains non-viable cells or tissues which are liable to act upon the human body with action that can be considered as primary to that of the medical devices.

(11) Where an advanced therapy medicinal product contains viable cells or tissues, the pharmacological, immunological or metabolic action of those cells or tissues is to be treated as the principal mode of action of the product.

(12) An advanced therapy medicinal product containing both autologous and allogeneic cells or tissues is to be treated as being for allogeneic use.

(13) A product which falls within the definition of a tissue engineered product and within the definition of a somatic cell therapy medicinal product is to be treated as a tissue engineered product.

(14) A product which falls within the definition of—

(a) a somatic cell therapy medicinal product or a tissue engineered product; and

(b) a gene therapy medicinal product,

is to be treated as a gene therapy medicinal product.]

Textual Amendments

F1 Reg. 2A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 4 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 1); 2020 c. 1, Sch. 5 para. 1(1)