The Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997

Regulation 2(2) and (3)

SCHEDULE 1INTERPRETATION

PART IExpressions having the same meaning as in the Homoeopathics Directive

• market

• person responsible for marketing

• homoeopathic stock

PART IIExpressions having the same meaning as in Directive 81/851

• batch

• detailed record

• import

• manufacture

• permanently and continuously at his disposal

• register or equivalent document

• sample

• third countries

Regulation 11(1)

SCHEDULE 2PROCEDURE WHERE THE MINISTERS PROPOSE TO TAKE CERTAIN ACTION ON GROUNDS RELATING TO SAFETY OR QUALITY

1.  Subject to paragraph 8(1), where the Ministers propose to act in a manner specified in regulation 11(1) (in this Schedule called“the proposed regulation 11(1) action”), the Ministers shall not act in that manner except after consultation with the Board.

2.  Where the Board is consulted pursuant to paragraph 1, the Board shall report to the Ministers their advice, and the reasons for their advice.

3.  After the Board has reported to the Ministers pursuant to paragraph 2, the Ministers, taking account of that report, may—

(a)finally determine not to take the proposed regulation 11(1) action, or

(b)provisionally determine to take that action.

4.  Where the Ministers provisionally determine to take the proposed regulation 11(1) action, they shall not act in that manner except after consultation with the Commission.

5.—(1) Where the Commission is consulted pursuant to paragraph 4, and they have reason to think that—

(a)on an Article 11 ground that concerns the safety or quality of the product, they may have to advise the Ministers that the registration of the product should be refused, or that it should not be registered unless the registration is made subject to certain specific obligations;

(b)on an Article 11 ground that concerns the safety or quality of the product, they may have to advise the Ministers that registration of the product should not be renewed, or that it should not be renewed unless the renewed registration is made subject to certain specific obligations;

(c)on a ground specified in Article 36 of Directive 81/851 that concerns the safety or quality of the product, they may have to advise the Ministers that the registration of the product ought to be suspended or revoked; or

(d)on a ground specified in Article 37.1 of Directive 81/851 that concerns the safety or quality of the product, they may have to advise the Ministers that a notice should be served under regulation 10(1),

the Commission, before giving that advice to the Ministers, shall serve a notice complying with the provisions of sub-paragraph (2) on the applicant, or the person responsible for marketing, as the case may be.

(2) Any notice served under sub-paragraph (1) shall—

(a)notify the person on whom it is served of the advice that the Commission is minded to give to the Ministers,

(b)state the reasons why the Commission is minded to give that advice, and

(c)specify that, on or before the response date specified in the notice, the person on whom the notice is served may make written representations to the Commission with respect to the advice or reasons.

6.  Where the Commission is consulted pursuant to paragraph 4, the Commission shall report to the Ministers their findings and advice, and the reasons for their advice, and, in a case where a notice has been served under paragraph 5(1), they shall make that report after considering any written representation made to them on or before the response date specified in that notice.

7.  After the Commission has reported to the Ministers pursuant to paragraph 6, the Ministers shall take that report into account in finally determining whether to take the proposed regulation 11(1) action.

8.—(1) The provisions of paragraph 1 shall not apply where the Ministers consider that it is necessary to take action of the type specified in regulation 11(1)(c) or (d) urgently in order to protect human or animal health or the environment.

(2) Where urgent action is taken by the Ministers, they shall—

(a)consult the Board within three months of taking the action, and

(b)comply with such of the provisions of this Schedule as are applicable in the circumstances to that action.

Regulation 12(1)

SCHEDULE 3PROCEDURE WHERE THE MINISTERS PROPOSE TO TAKE CERTAIN ACTION ON GROUNDS OTHER THAN GROUNDS RELATING TO SAFETY OR QUALITY

1.—(1) Where the Ministers propose to act in a manner specified in regulation 12(1) (in this Schedule called “the proposed regulation 12(1) action”), the Ministers shall not take such action unless, before doing so, they serve a notice complying with the requirements of sub-paragraph (2) on the applicant, or the person responsible for marketing the product, as the case may be.

(2) A notice served by the Ministers under sub-paragraph (1) shall—

(a)state what regulation 12(1) action the Ministers propose to take,

(b)state their reasons for proposing to take such action, and

(c)specify that, on or before the response date specified in such notice, the person on whom such notice is served make written representations to the Ministers with respect to the proposed action.

2. Where a person on whom a notice is served makes written representations to the Ministers on or before the response date specified in the notice, the Ministers shall consider those representations before determining whether to take the proposed regulation 12(1) action.

Regulation 17

SCHEDULE 4PROCEDURE WHERE THE MINISTERS PROPOSE TO REFUSE ARTICLE 24 AUTHORISATIONS OR TO SUSPEND OR REVOKE SUCH AUTHORISATIONS

1.—(1) Where the Ministers propose to act in a manner specified in regulation 17 (in this Schedule called “the proposed regulation 17 action”), the Ministers shall not take such action unless, before doing so, they serve a notice complying with the requirements of sub-paragraph (2) on the applicant or the authorisation holder, as the case may be.

(2) A notice served by the Ministers under sub-paragraph (1) shall—

(a)state what regulation 17 action the Ministers propose to take,

(b)state their reasons for proposing to take such action, and

(c)specify that, on or before the response date specified in such notice, the person on whom such notice is served may make written representations to the Ministers with respect to proposed action.

2.  Where a person on whom such notice is served under paragraph 1(1) makes written representations to the Ministers on or before the response date specified in the notice, the Ministers shall consider those representations before determining whether to take the proposed regulation 17 action.

Regulation 34

SCHEDULE 5APPLICATION OF VARIOUS SECTIONS OF THE ACT

• sections 51 to 54 (provisions as to sale or supply of medicinal products)

• sections 55 to 57 (exemptions from sections 52 and 53 of the Act)

• sections 58 and 59 to 61 (additional provisions)

• section 67 (offences)

• sections 92 to 95 and 97 (promotion of sales of medicinal products)

• section 107 (validity of decisions and proceedings relating thereto)

• section 108 to 110 (enforcement)

• section 111 (rights of entry)

• section 112 (powers to inspect, take samples and seize goods and documents)

• section 113 (application of sampling procedures)

• section 114 (supplementary provisions as to rights of entry and related rights)

• section 115 (analysis of samples in other cases)

• section 119 (protection for officers of enforcement authorities)

• section 121 (contravention due to default of other person)

• section 122 (warranty as defence)

• section 123 (offences in relation to warranties and certificates of analysis)

• section 124 (offences by bodies corporate)

• section 125 (prosecutions)

• section 126 (presumptions)

• section 127 (service of documents)

• section 129 (order and regulations)

• section 132 (general interpretation provisions)

• section 133(2) (general provisions as to operation of the Act)

• section 134(3), (4) and (5) (special provisions as to Northern Ireland)

• Schedule 3 (sampling)

• Schedule 4 (provisions relating to Northern Ireland)

Regulation 37

SCHEDULE 6AMENDMENT

The Medicines (Restrictions on the Administration of Veterinary Medicinal Products) Regulations 1994(1) shall be amended as follows—

(a)in regulation 2(1)—

(i)the word “and” following the definition of “ready-made veterinary medicinal product” shall be omitted, and the following definition shall be inserted after that definition—

““registered homoeopathic veterinary medicinal product” means a homoeopathic veterinary medicinal product registered under the Registration of Homoeopathic Veterinary Medicinal Products Regulations 1997, and”, and

(ii)in the definition of “veterinary medicinal product”, after the words “to which Article 2.1 of that Directive applies”, the words “and shall include a homoeopathic veterinary medicinal product as defined in Article 1.1 of Council Directive 92/74/EEC” shall be inserted,

(b)in regulation 3, after the words “in respect of that product”, the words “or the product is a registered homoeopathic veterinary medicinal product” shall be inserted, and

(c)in regulation 5(1)—

(i)for the words “or authorised veterinary medicinal product” the words “, authorised veterinary medicinal product or registered homoeopathic veterinary medicinal product” shall be substituted, and

(ii)in sub-paragraph (a), after the words “in the same species”, the words “or a registered homoeopathic veterinary medicinal product registered for administration to another animal species” shall be inserted.