Paragraph 12 Labelling an intermediate feedingstuff containing a medicinal premixF15F16E1
England, Wales and Scotland
F1An intermediate feedingstuff containing a F2medicinal premix must be clearly and legibly labelled with the following—
the words “F3INTERMEDIATE FEEDINGSTUFF” (or, if it is to be labelled as “complementary feedingstuffs” under legislation implementing Council Directive 79/373/EEC on the marketing of compound feedingstuffsf1, “MEDICATED COMPLEMENTARY FEEDINGSTUFFS” ) in upper case letters;
the proprietary name of the F4medicinal premix and the authorisation number;
the name and amount of the active substance (mg/kg) in the F5intermediate feedingstuff;
the range of acceptable inclusion rates of the F6intermediate feedingstuff into the final feedingstuffs, the range of acceptable levels of the active ingredients in the final feedingstuffs and the words “refer to the F7medicated feedingstuffs prescription for the exact inclusion rate” or equivalent wording;
warnings and contra-indications;
a statement that the product must be used in accordance with its summary of product characteristics;
the contact details (including a free helpline number) for the supplier of the product;
the words “inappropriate disposal of this product poses a serious threat to the environment”;
in the case of a product containing an antibiotic, the words “inappropriate disposal of this product may contribute to antimicrobial resistance”;
the withdrawal period, and a statement that, if the F9medicated feedingstuffs prescription requires a longer withdrawal period, that is the one that applies;
the expiry date;
any special storage instructions F10required by the marketing authorisation;
where a F11medicated feedingstuffs prescription is required, a statement to this effect.
If there is more than one F12medicinal premix used, the longest withdrawal period must be shown on the label.
If the F13intermediate feedingstuff also contains a specified feed additive to which this Schedule applies it must also contain the information required under Article 16 of Regulation (EC) No 1831/2003f2.
No person may supply such F14an intermediate feedingstuff unless it is labelled in accordance with this paragraph.
Annotations
Textual amendments
- F1
Words in Sch. 5 para. 12(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(i)(aa) (with reg. 205)
- F2
Words in Sch. 5 para. 12(1) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(i)(bb) (with reg. 205)
- F3
Words in Sch. 5 para. 12(1)(a) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(ii) (with reg. 205)
- F4
Words in Sch. 5 para. 12(1)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(iii) (with reg. 205)
- F5
Words in Sch. 5 para. 12(1)(c) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(iv) (with reg. 205)
- F6
Words in Sch. 5 para. 12(1)(d) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(v)(aa) (with reg. 205)
- F7
Words in Sch. 5 para. 12(1)(d) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(v)(bb) (with reg. 205)
- F8
Sch. 5 para. 12(1)(ea)-(ed) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(vi) (with reg. 205)
- F9
Words in Sch. 5 para. 12(1)(f) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(vii) (with reg. 205)
- F10
Words in Sch. 5 para. 12(1)(h) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(viii) (with reg. 205)
- F11
Words in Sch. 5 para. 12(1)(i) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(a)(ix) (with reg. 205)
- F12
Words in Sch. 5 para. 12(2) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(b) (with reg. 205)
- F13
Words in Sch. 5 para. 12(3) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(c) (with reg. 205)
- F14
Words in Sch. 5 para. 12(4) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(d) (with reg. 205)
- F15
Words in Sch. 5 para. 12 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(e)(i) (with reg. 205)
- F16
Words in Sch. 5 para. 12 heading substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 134(e)(ii) (with reg. 205)
Extent
- E1
This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Footnotes
- f1
-
OJ No L86, 6.4.1979, p. 30.
- f2
-
OJ No L268, 18.10.2003, p. 29. Regulation (EC) no 1831/2003 was last amended by Article 29 of Regulation (EC) No 767/2009 (OJ No L229, 1.9.2009, p. 1.)