Textual Amendments
F1Words in Sch. 1 heading inserted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Residues (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1461), regs. 1(2)(b), 4(7)(a)
F2Words in Sch. 1 heading inserted (N.I.) (31.12.2020) by The Animals (Health, Identification, Trade and Veterinary Medicines) (Amendment) (EU Exit) Regulations (Northern Ireland) 2020 (S.R. 2020/353), regs. 1(3), 10(13)(a)
24.—(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.
(2) In addition, the Secretary of State must refuse to grant it if—
(a)the data submitted with the application are inadequate;
(b)the risk-benefit balance of the veterinary medicinal product is unfavourable;
(c)the product has insufficient therapeutic effect;
(d)the withdrawal period proposed by the applicant is not long enough to ensure [F3food safety], or is insufficiently substantiated;
(e)the veterinary medicinal product is for a prohibited use;
(f)the way that the product will be used will have an unnecessarily undesirable effect on the environment.
(3) The Secretary of State may refuse to grant a marketing authorisation—
(a)if there is F4... legislation pending that is incompatible with the requested authorisation; or
(b)if additional data have been requested and those data are not provided within such time limit as may be stipulated.
(4) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to refuse an application, or proposes to grant a marketing authorisation that is different from the one applied for, the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee.
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F3Words in Sch. 1 para. 24(2)(d) substituted (E.W.S.) (31.12.2020) by The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(21)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F4Word in Sch. 1 para. 24(3)(a) omitted (E.W.S.) (31.12.2020) by virtue of The Veterinary Medicines and Animals and Animal Products (Examination of Residues and Maximum Residue Limits) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/676), regs. 1(2)(b), 3(21)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
24.—(1) The Secretary of State must refuse to grant a marketing authorisation if the application does not comply with these Regulations.
(2) In addition, the Secretary of State must refuse to grant it if—
(a)the data submitted with the application are inadequate;
(b)the risk-benefit balance of the veterinary medicinal product is unfavourable;
(c)the product has insufficient therapeutic effect;
(d)the withdrawal period proposed by the applicant is not long enough to ensure that Regulation (EC) No 470/2009 of the European Parliament and of the Council is complied with, or is insufficiently substantiated;
(e)the veterinary medicinal product is for a prohibited use;
(f)the way that the product will be used will have an unnecessarily undesirable effect on the environment.
(3) The Secretary of State may refuse to grant a marketing authorisation—
(a)if there is Community legislation pending that is incompatible with the requested authorisation; or
(b)if additional data have been requested and those data are not provided within such time limit as may be stipulated.
(4) If the Secretary of State, on the grounds of safety, quality or efficacy, intends to refuse an application, or proposes to grant a marketing authorisation that is different from the one applied for, the Secretary of State must notify the applicant accordingly, and the applicant may appeal to the Veterinary Products Committee.
Extent Information
E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only