Paragraph 64 Application for registrationE1

England, Wales and Scotland

(1)

An applicant for registration must submit the following to the Secretary of State—

(a)

the scientific name or other name of the homeopathic stock F1or stocks given in a pharmacopoeia, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution;

(b)

a dossier describing how the homeopathic stock is F2, or stocks are, obtained and controlled, and justifying F3their homeopathic F4use, on the basis of an adequate bibliography;

(c)

in the case of a product containing biological substances, a description of the measures taken to ensure the absence of pathogens;

(d)

the manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentisation;

(e)

a copy of the manufacturing authorisation for the product;

(f)

copies of any registrations F5... obtained for the same homeopathic remedyF6...;

F7(g)

the text which is to appear on the package leaflet, outer packaging and immediate packaging of the homeopathic remedy;

F8(h)

any relevant data concerning the stability of the homeopathic remedy;

(i)

the proposed withdrawal period necessary to ensure that the provisions of Regulation (EC) No 470/2009 of the European Parliament and of the Council are complied with together with all necessary justification.

(2)

These documents must demonstrate the pharmaceutical quality and the batch-to-batch homogeneity of the products concerned.

(3)

In the case of a food-producing animal, if the applicant states in the application that the homeopathic remedy contains an active substance, or has been manufactured using an active substance, that substance must be one F9for which a maximum residue limit has been established under Regulation (EC) No 470/2009 of the European Parliament and of the Council.

F10(4)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Annotations

Textual amendments

F1: Words in Sch. 1 para. 64(1)(a) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(a)
F2: Words in Sch. 1 para. 64(1)(b) inserted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(b)(i)
F3: Word in Sch. 1 para. 64(1)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(b)(ii)
F4: Word in Sch. 1 para. 64(1)(b) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(b)(iii)
F5: Words in Sch. 1 para. 64(1)(f) omitted (E.W.S.) (17.5.2024) by virtue of The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(c)
F6: Words in Sch. 1 para. 64(1)(f) 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(32)(a) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F7: Sch. 1 para. 64(1)(g) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(d)
F8: Sch. 1 para. 64(1)(h) substituted (E.W.S.) (17.5.2024) by The Veterinary Medicines (Amendment etc.) Regulations 2024 (S.I. 2024/567), regs. 1(1), 76(e)
F9: Words in Sch. 1 para. 64(3) 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(32)(b) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)
F10: Sch. 1 para. 64(4) 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(32)(c) (as amended by S.I. 2020/1461, regs. 1(2)(a), 3(2)(b)); 2020 c. 1, Sch. 5 para. 1(1)

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

Notes on Schedule 1

Textual amendments

F1: Words 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)
F2: Words 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)