PART 2U.K.LICENSING OF ACTIVITIES RELATING TO THE USE OF TISSUE FOR HUMAN APPLICATION

Breach of requirement to hold a licence or to act under a third party agreementU.K.

10.—(1) A person who contravenes regulation 7(1) commits an offence unless he reasonably believes—

(a)that what he does is not an activity to which regulation 7(1) applies; or

(b)that he acts under the authority of a licence under Schedule 1.

[F1(1A) A person who contravenes regulation 7(1A) commits an offence unless he reasonably believes—

(a)that what he does is not an activity to which regulation 7(1A) applies; or

(b)that he acts—

(i)under the authority of a licence under Schedule 1; or

(ii)in pursuance of an authorisation under regulation 7(4).]

(2) A person who contravenes regulation 7(2) commits an offence unless he reasonably believes—

(a)that what he does is not an activity to which regulation 7(2) applies; or

(b)that he acts—

(i)under the authority of a licence under Schedule 1,

(ii)in pursuance of a third party agreement, or

(iii)in pursuance of an authorisation under regulation 7(4).

[F2(2A) A person who contravenes regulation 7A commits an offence unless he reasonably believes—

(a)that what he does is not an activity to which regulation 7A applies; or

(b)that an exception under regulation 7A(1)(a) or (b) applies.]

(3) A person guilty of an offence under [F3paragraph (1), (1A), (2) or (2A)] shall be liable—

(a)on summary conviction to a fine not exceeding the statutory maximum;

(b)on conviction on indictment—

(i)to imprisonment for a term not exceeding 2 years, or

(ii)to a fine, or

(iii)to both.

Textual Amendments

F1Reg. 10(1A) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(3)(a)

F2Reg. 10(2A) inserted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(3)(b)

F3Words in reg. 10(3) substituted (6.3.2018 for specified purposes, 1.4.2018 in so far as not already in force) by The Human Tissue (Quality and Safety for Human Application) (Amendment) Regulations 2018 (S.I. 2018/335), regs. 1(2)(3), 3(3)(c)