2.  A veterinary medicinal product intended solely for an animal to which this Schedule applies may be placed on the market, imported or administered without a marketing authorisation if it complies with this Schedule [F1and the manufacturer appears on the register maintained under paragraph 3A].

ManufactureE+W+S

3.—[F2(1)] The product must have been manufactured by—

(a)the holder of a manufacturing authorisation if manufactured in [F3Great Britain];

F4(b). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F5(c). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d)in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.

[F6(2) Sub-paragraph (1)(d) does not apply where the United Kingdom has a formal agreement with the exporting country that includes mutual recognition of good manufacturing practice or where the Secretary of State is satisfied that the exporting country requires manufacturers of veterinary medicinal products to apply standards of good manufacturing practice which are at least equivalent to those in Great Britain.]

ManufactureN.I.

3.  The product must have been manufactured by—

(a)the holder of a manufacturing authorisation if manufactured in the United Kingdom;

(b)the holder of a manufacturing authorisation issued under Directive 2001/82/EC if manufactured in [F15a] member State;

(c)in the case of Australia, Canada, New Zealand, or Switzerland, the holder of an authorisation from the competent authority permitting the manufacture of medicinal products;

(d)in the case of any other country, a manufacturer whose premises have been inspected and approved by an officer of the Secretary of State.

[F7Register of persons placing veterinary medicinal products on the market (small pet animals)E+W+S

3A.—(1) A person placing the product on the market must be registered in accordance with this paragraph.

(2) An application for registration in respect of that person must be submitted under sub-paragraph (4)—

(a)at least two months before that person places the product on the market, or

(b)where that person has already placed the product on the market, within six months of the date on which this provision comes into force.

(3) Information may be submitted to the Secretary of State pursuant to sub-paragraph (2) prior to the date on which this provision comes into force, and in such a case—

(a)as regards an applicant for registration who has not already placed the product on the market, the period of two months is to be treated as having started on the date of submission;

(b)as regards an applicant for registration who has already placed the product on the market, the information is to be treated as having been submitted within the period of six months.

(4) An application for registration must be made to the Secretary of State electronically and must include—

(a)the name and address of the person placing the product on the market;

(b)the individual making the application in respect of that person;

(c)the telephone number and email address of the individual mentioned in sub-paragraph (b);

(d)the name and address of the manufacturer of the product;

(e)the brand name of the product;

(f)the names and quantities of the active substances;

(g)the method and (where applicable) route of administration;

(h)the dosage instructions;

(i)the category of animal mentioned in paragraph 1 for which the product is intended.

(5) For the purposes of sub-paragraph (1) the Secretary of State must establish and maintain a register of persons placing on the market products to which this Schedule applies.

(6) The particulars entered on the register must include the name and the address of the person mentioned in sub-paragraph (1).]

[F7Persons registered in accordance with paragraph 3A: annual returnE+W+S

3B.  At least once each calendar year a person registered under paragraph 3A must notify the Secretary of State in writing of the following in respect of each product placed on the market—

(a)the name and registered address of the person (if different from that listed on the register);

(b)the individual designated for the purpose of making the annual return under this paragraph;

(c)the telephone number and email address of the individual mentioned in sub-paragraph (b);

(d)the name and address of the manufacturer of the product;

(e)the brand name of the product;

(f)the names and quantities of the active substances;

(g)the method and (where applicable) route of administration;

(h)the dosage instructions;

(i)the category of animal mentioned in paragraph 1 for which the product is intended.]

Approval of the active substanceE+W+S

4.—(1) The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.

(2) The Secretary of State may not grant an approval if the active substance requires veterinary control.

(3) The approval must specify the species of animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.

(4) The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—

(a)it is demonstrated that the substance requires veterinary control;

(b)[F8adverse events] are reported making suspension or revocation necessary; or

(c)it is demonstrated that the substance—

(i)is carcinogenic;

(ii)is genotoxic; or

(iii)shows developmental toxicity (including teratogenicity).

(5) The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.

Approval of the active substanceN.I.

4.—(1) The Secretary of State may approve an active substance for use in a veterinary medicinal product manufactured under this Schedule.

(2) The Secretary of State may not grant an approval if the active substance requires veterinary control.

(3) The approval must specify the species of animals for which it is approved, and may specify how the active substance or a product containing it is to be administered.

(4) The Secretary of State may suspend or revoke the approval (or limit it to a smaller number of species) if—

(a)it is demonstrated that the substance requires veterinary control;

(b)serious adverse reactions are reported making suspension or revocation necessary; or

(c)it is demonstrated that the substance—

(i)is carcinogenic;

(ii)is genotoxic; or

(iii)shows developmental toxicity (including teratogenicity).

(5) The procedure for the refusal, suspension or revocation of an approval under this paragraph is the same as the procedure for a marketing authorisation.

The productU.K.

5.—(1) The active substance in the veterinary medicinal product must be approved under paragraph 4.

(2) The veterinary medicinal product must not be an antibiotic.

(3) It must not contain any narcotic or psychotropic substance.

(4) It must not be intended for treatments or pathological processes that require a precise prior diagnosis or the use of which may cause effects that impede or interfere with subsequent diagnostic or therapeutic measures.

LabellingU.K.

6.—(1) The product must be clearly labelled as being exempt from the requirements of these Regulations in relation to a marketing authorisation.

(2) The labelling must show the following—

(a)the name of the veterinary product, including, if it is part of the name, its strength and pharmaceutical form;

(b)the authorisation number of the manufacturer;

(c)the name and strength of each active substance;

(d)the route of administration;

(e)the batch number;

(f)the expiry date;

(g)the words “For animal treatment only”;

(h)the contents by weight, volume or number of dose units;

(i)the name and address of the manufacturer or distributor;

(j)the target species;

(k)the words “Keep out of reach of children”;

(l)storage instructions;

(m)the shelf-life after the immediate packaging has been opened for the first time;

(n)disposal advice;

(o)full indications, including—

(i)therapeutic indications;

(ii)contra-indications;

(iii)interaction with other medicines and other forms of interaction; and

(p)dosage instructions.

(3) If there is insufficient room on the label, the information may instead be in a package leaflet, but the leaflet must contain all the information in the preceding sub-paragraph other than the batch number and the expiry date, but the label on the product must contain at least the following—

(a)the name of the veterinary medicinal product;

(b)its active substance and its strength;

(c)the route of administration;

(d)the batch number;

(e)the expiry date; and

(f)the words “For animal treatment only”.

AdministrationU.K.

7.  The method of administration must be oral or topical or (in the case of a product for fish) by addition to the water.

Pack sizeU.K.

8.  The pack size must only be sufficient for a single course of treatment or, in the case of a veterinary medicinal product for aquarium fish, sufficient for a single course of treatment of no more than 7 administrations to an aquarium of 25,000 litres.

[F9Adverse events]E+W+S

9.—(1) The [F10manufacturer or importer] of a veterinary medicinal product must—

(a)notify the Secretary of State within 15 days of learning of any serious [F11adverse events]; and

(b)make a record of each [F12adverse event] and serious [F12adverse event] on becoming aware of it and keep it for three years.

F13(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Adverse reactionsN.I.

9.—(1) The manufacturer, importer or retailer of a veterinary medicinal product must—

(a)notify the Secretary of State within 15 days of learning of any serious adverse reactions (as defined in paragraph 57 of Schedule 1); and

(b)make a record of each adverse reaction and serious adverse reaction on becoming aware of it and keep it for three years.

(2) It is an offence to fail to comply with this paragraph.

[F14OffencesE+W+S

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

(a)paragraph 3A(1);

(b)paragraph 3B; or

(c)paragraph 9(1).]