The Veterinary Medicines Regulations 2013

[F1 PART 2B U.K. Schedule 2 Offences]

Textual Amendments

F1 Sch. 2 Pts. 2A (paras. 26-31), 2B (para. 32) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 93

[F1 Offences E+W+S

32.   It is an offence to fail to comply with—

(a) paragraph 1;

(b) paragraph 4(3);

(c) paragraph 8;

(d) paragraph 11;

(e) paragraph 15;

(f) paragraph 18;

(g) paragraph 19;

(h) paragraph 20(1), (3) or (4);

(i) paragraph 22;

(j) paragraph 23;

(k) paragraph 24;

(l) paragraph 26;

(m) paragraph 28;

(n) paragraph 29.]

Extent Information

E1 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Labelling N.I.

32.—(1) The operator of an equine stem cell centre must ensure that every container used for the stem cell product is labelled with—

(a) the identification of the donor animal;

(b) the date of collection;

(c) the authorisation number of the equine stem cell centre;

(d) any necessary warnings;

(e) the expiry date.

(2) The operator of an equine stem cell centre must ensure that no specific therapeutic indication is included on the label or on any information relating to the product.

Extent Information

E5 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Records E+W+S

33.  F2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E2 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F2 Sch. 2 Pt. 2 (paras. 14-25 entitled "Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade") substituted for Sch. 2 Pt. 2 (paras. 14-19 entitled "Authorisation of manufacturers of autogenous vaccines"), Pt. 3 (paras. 20-24 entitled "Authorisation of blood banks"), Pt. 4 (paras. 25-29 entitled "Authorisation of manufacturers of products for administration under the cascade") and Pt. 5 (paras. 30-35 entitled "Authorisation of equine stem cell centres") (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 92

Records N.I.

33.  The operator of an equine stem cell centre must, as soon as is reasonably practicable, record for each stem cell product—

(a) the identification of the donor animal;

(b) the date of collection;

(c) the veterinary surgeon under whose responsibility the stem cells were collected;

(d) the expiry date;

(e) the date the product was used or, if it was supplied to another veterinary surgeon, the name of that veterinary surgeon and the date it was supplied,

and must keep the records for at least five years.

Extent Information

E6 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only

Inspection of premises E+W+S

34.  F2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E3 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F2 Sch. 2 Pt. 2 (paras. 14-25 entitled "Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade") substituted for Sch. 2 Pt. 2 (paras. 14-19 entitled "Authorisation of manufacturers of autogenous vaccines"), Pt. 3 (paras. 20-24 entitled "Authorisation of blood banks"), Pt. 4 (paras. 25-29 entitled "Authorisation of manufacturers of products for administration under the cascade") and Pt. 5 (paras. 30-35 entitled "Authorisation of equine stem cell centres") (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 92

Inspection of premises N.I.

34.  The Secretary of State must inspect the authorised premises, basing the frequency of the inspection on the risks associated with each premises’ history and the nature of the products handled at the premises.

Offences E+W+S

35.  F2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Extent Information

E4 This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only

Textual Amendments

F2 Sch. 2 Pt. 2 (paras. 14-25 entitled "Authorisation of autogenous vaccines, blood-banks, stem cell centres and products manufactured under the cascade") substituted for Sch. 2 Pt. 2 (paras. 14-19 entitled "Authorisation of manufacturers of autogenous vaccines"), Pt. 3 (paras. 20-24 entitled "Authorisation of blood banks"), Pt. 4 (paras. 25-29 entitled "Authorisation of manufacturers of products for administration under the cascade") and Pt. 5 (paras. 30-35 entitled "Authorisation of equine stem cell centres") (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 92

Offences N.I.

35.  It is an offence to fail to comply with—

(a) paragraph 4(3);

(b) paragraph 11;

(c) paragraph 14(4);

(d) paragraph 16;

(e) paragraph 17;

(f) paragraph 18;

(g) paragraph 20(6) or (7);

(h) paragraph 21;

(i) paragraph 22;

(j) paragraph 23;

(k) paragraph 25(5);

(l) paragraph 26;

(m) paragraph 27;

(n) paragraph 28;

(o) paragraph 30(4) or (6);

(p) paragraph 31;

(q) paragraph 32; or

(r) paragraph 33.

Extent Information

E7 This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only