Human Tissue Act 2004 (c. 30)

SCHEDULES

SCHEDULE 3 E+W+N.I. Licences for the purposes of section 16

Characteristics of licence E+W+N.I.

2 (1) A licence shall not authorise the carrying-on of more than one activity to which section 16 applies. E+W+N.I.

(2) A licence shall—

(a) specify the premises where the licensed activity is authorised to be carried on, and

(b) designate an individual as the person under whose supervision the licensed activity is authorised to be carried on.

(3) A licence shall not authorise the licensed activity to be carried on—

(a) on premises at different places, or

(b) under the supervision of more than one individual.

(4) It shall be a condition of a licence—

(a) that the licensed activity shall be carried on only on the premises specified in the licence;

(b) that the licensed activity shall be carried on only under the supervision of the individual designated in the licence as the person under whose supervision it is authorised to be carried on;

(c) that such information about such matters relating to the carrying-on of the licensed activity as may be specified in directions shall be recorded in such form as may be so specified;

(d) that any record made for the purposes of the condition in paragraph (c) shall be kept until the end of such period as may be specified in directions;

(e) that there shall be provided to such person and at such intervals as may be specified in directions—

(i) such copies of, or extracts from, any record to which the condition in paragraph (d) relates, and

(ii) such other information,

as may be so specified;

(f) that there shall be paid to the Authority at such times as may be specified in directions sums of such amount as may be so specified in respect of its costs in connection with superintending compliance with the terms of licences.

(5) Directions for the purposes of sub-paragraph (4) may be given in relation to licences generally, licences of a particular description or a particular licence.

Modifications etc. (not altering text)

C1 Sch. 3 para. 2(4)(c)-(f) applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3)8(2)(e)(6)(7) (with reg. 2(3))

C2 Sch. 3 para. 2(4)(c)-(f) applied (with modifications) (12.7.2012 for specified purposes, 27.8.2012 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3), 6

C3 Sch. 3 para. 2(4)(c)-(f) amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4

C4 Sch. 3 para. 2(5) applied (with modifications) (25.5.2007 for specified purposes, 5.7.2007 in so far as not already in force) by Human Tissue (Quality and Safety for Human Application) Regulations 2007 (S.I. 2007/1523), reg. 1(2)(3), 8(2)(e)(6)(7) (with reg. 2(3))

C5 Sch. 3 para. 2(5) applied (with modifications) (12.7.2012 for specified purposes, 27.8.2012 in so far as not already in force) by The Quality and Safety of Organs Intended for Transplantation Regulations 2012 (S.I. 2012/1501), reg. 1(2)(3), 6

C6 Sch. 3 para. 2(5) amendment to earlier affecting provision S.I. 2012/1501 reg. 6 (14.7.2014) by The Quality and Safety of Organs Intended for Transplantation (Amendment) Regulations 2014 (S.I. 2014/1459), regs. 1(1), 4

Commencement Information

I1 Sch. 3 para. 2 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)

I2 Sch. 3 para. 2 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)

I3 Sch. 3 para. 2 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)

I4 Sch. 3 para. 2 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)

I5 Sch. 3 para. 2 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)

3 (1) This paragraph applies to a licence authorising the storage of anatomical specimens. E+W+N.I.

(2) It shall be a condition of a licence to which this paragraph applies that storage at the premises specified in the licence of the body of a deceased person for use for the purpose of anatomical examination shall not begin before that body’s storage there for use for that purpose has been authorised in writing by—

(a) the designated individual, or

(b) an individual who has the Authority’s permission to give such authorisation (see paragraph 12).

(3) It shall be a condition of a licence to which this paragraph applies that any anatomical specimen which is stored at the premises specified in the licence shall be released from storage at the premises only into the possession of a person who is authorised in writing by the designated individual to have the specimen in his possession.

(4) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give authority for the purposes of the condition in sub-paragraph (3) only if he is satisfied—

(a) that the person to whom authority is given is a suitable person to have the specimen in his possession, and

(b) that that person intends to use the specimen only for the purpose of education, training or research.

(5) It shall be a condition of a licence to which this paragraph applies that any authority given for the purposes of the condition in sub-paragraph (3) shall specify—

(a) the person to whom the authority is given,

(b) the specimen to which the authority relates,

(c) the purpose for which the specimen may be used, and

(d) the duration of the authority.

(6) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give such notice of any authorisation for the purposes of the condition in sub-paragraph (3) as may be specified in directions.

(7) It shall be a condition of a licence to which this paragraph applies that such information about authorisations for the purposes of the condition in sub-paragraph (3) as may be specified in directions shall be recorded in such form as may be so specified.

Commencement Information

I6 Sch. 3 para. 3 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)

I7 Sch. 3 para. 3 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)

I8 Sch. 3 para. 3 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)

I9 Sch. 3 para. 3 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)

I10 Sch. 3 para. 3 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)

4 (1) This paragraph applies to a licence authorising the activity mentioned in section 16(2)(e). E+W+N.I.

(2) It shall be a condition of a licence to which this paragraph applies that any former anatomical specimen which is stored at the premises specified in the licence shall be released from storage at the premises only into the possession of a person who is authorised in writing by the designated individual to have the specimen in his possession.

(3) The condition in sub-paragraph (2) does not apply to the release from storage of a specimen for the purpose of its decent disposal.

(4) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give authority for the purposes of the condition in sub-paragraph (2) only if he is satisfied—

(a) that the person to whom authority is given is a suitable person to have the specimen in his possession, and

(b) that that person intends to use the specimen only for the purpose of education, training or research.

(5) It shall be a condition of a licence to which this paragraph applies that any authority given for the purposes of the condition in sub-paragraph (2) shall specify—

(a) the person to whom the authority is given,

(b) the specimen to which the authority relates,

(c) the purpose for which the specimen may be used, and

(d) the duration of the authority.

(6) It shall be a condition of a licence to which this paragraph applies that the designated individual shall give such notice of any authorisation for the purposes of the condition in sub-paragraph (2) as may be specified in directions.

(7) It shall be a condition of a licence to which this paragraph applies that such information about authorisations for the purposes of the condition in sub-paragraph (2) as may be specified in directions shall be recorded in such form as may be so specified.

Commencement Information

I11 Sch. 3 para. 4 in force at 20.10.2005 for specified purposes by S.I. 2005/2792, art. 2(2)(j)

I12 Sch. 3 para. 4 in force at 1.3.2006 for specified purposes by S.I. 2006/404, art. 2(3)(4), Sch. (with arts. 4-6)

I13 Sch. 3 para. 4 in force at 7.4.2006 for specified purposes by S.I. 2006/404, art. 3(3), Sch. (with arts. 4-6)

I14 Sch. 3 para. 4 in force at 31.7.2006 for specified purposes by S.I. 2006/1997, art. 2, Sch. (with art. 4)

I15 Sch. 3 para. 4 in force at 1.9.2006 in so far as not already in force by S.I. 2006/1997, art. 3(2) (with arts. 4, 7, 8)