Control on Animal Vaccines Regulations 2014

• Jurisdiction: Ireland
• Citation: IR SI 193/2014
• Year: 2014

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 6th May, 2014.

I, SIMON COVENEY, Minister for Agriculture, Food and the Marine in exercise of the powers conferred on me by sections 36 of the Animal Health and Welfare Act 2013 (No. 15 of 2013), for the purpose, inter alia, of giving further effect to Regulation 71 of Directive 2001/82/EC of the European Parliament and the Council of 6 November 20011 , hereby make the following regulations:

Citation

1. These Regulations may be cited as the Control on Animal Vaccines Regulations 2014

Interpretation

2. In these Regulations—

"Act" means Animal Health and Welfare Act 2013 (No. 15 of 2013);

“animal remedy” has the same meaning as in the Animal Remedies Act 1993 (No. 23 of 1993);

“authorised animal remedy” means an animal remedy that is the subject of an animal remedies authorisation under the European Communities (Animal Remedies) (No.2) Regulations 2007;

“vaccine” means an animal remedy that may be administered to an animal to produce active or passive immunity or to diagnose the state of immunity.

Prohibition on certain vaccines, etc.

3. (1) A person shall not have in his or her possession or under his or her control, import, sell, supply or administer to an animal a vaccine that may be used to produce active or passive immunity to a disease specified in Schedule 1 or, to diagnose the state of immunity to the disease.

(2) A person shall not have in his or her possession or under his or her control, sell or supply an animal to which a vaccine, that may be used to produce active or passive immunity to a disease specified in Schedule 1 or to diagnose the state of immunity to the disease, has been administered.

Restriction on certain vaccines, etc.

4. (1) Subject to paragraph (3), a person shall not have in his or her possession or under his or her control, import, sell, supply or administer to an animal a vaccine that may be used to produce active or passive immunity to a disease specified in Schedule 2 or to diagnose the state of immunity to the disease except in accordance with a licence (“vaccine licence”).

(2) A person shall not have in his or her possession or under his or her control, sell or supply an animal to which a vaccine, that may be used to produce active or passive immunity to a disease specified in Schedule 2 has been administered or to diagnose the state of immunity to the disease, unless the vaccine—

(a) was administered in accordance with a vaccine licence, or

(b) is a vaccine to which paragraph (3) applies.

(3) A person may have in his or her possession or under his or her control, import, sell, supply or administer to an animal a marker vaccine (that is an authorised animal remedy) to produce active or passive immunity to a disease specified in Part 2 of Schedule 2 or to diagnose the state of immunity to the disease.

(4) The Minister may grant a licence, refuse an application or revoke a vaccine licence.

(5) An application for a vaccine licence shall be made in a form, be accompanied by any material and contain any particulars that the Minister specifies.

(6) The Minister shall not consider an application for a vaccine licence if the application does not contain all the material and particulars sought by the Minister.

(7) The Minister may attach conditions to a vaccine licence, revoke or vary a condition or attach a new condition.

(8) Without prejudice to the generality of paragraph (7), a condition to a vaccine licence may—

(a) control the use of a vaccine to which the licence relates

(b) specify the person or class of persons to whom a vaccine may be sold or supplied,

(c) specify the person or classes of person who may administer a vaccine to an animal,

(d) specify the animal or class of animal to which the vaccine may be administered,

(e) specify records to be maintained,

(f) bind the person to whom the vaccine licence is granted and such other person or classes of person as may be specified in the licence, and

(g) specify such other conditions as are, in the opinion of the Minister, necessary ancillary or desirable for a vaccine licence to have full effect.

(9) Without prejudice to the generality of paragraph (4), the Minister may refuse an application or revoke a vaccine licence if–

(a) the applicant or licensee has been convicted of, or committed, an...