S.L. 437.47 Art. 77AAdvertising of veterinary medicinal products regulations.

(1)The Veterinary Services shall permit the advertising of veterinary medicinal products that in accordance with regulation

60, are available on veterinary prescription to:

(a) veterinary surgeons and pharmacists;

(b) professional keepers of animals, provided that the veterinary medicinal products are preventive immunological products or anti-helmintic therapies.

(2) The Veterinary Services shall permit the advertising of veterinary medicinal products to the general public which, by virtue of their composition and purpose, are intended and designed for use with the advice of the pharmacist, if necessary, but without the intervention of a veterinary surgeon for diagnostic purposes or for the prescription or monitoring of treatment.

(3) No person may advertise medicinal product for administration to animals. Scientific informative material can be sent on request to the veterinary surgeon when the provisions of regulation 10 and 11 are to be applied. The information must not be promotional in nature and must not include a price list.

(4) (a) It shall not be permissible for persons allowed to supply veterinary medicinal products to veterinary surgeons or pharmacy owners to induce them to prescribe or supply veterinary medicinal products by the gift, offer or promise of any benefit or bonus, whether in money or in kind.

(b) It shall not be permissible for persons allowed to supply veterinary medicinal products to make any form of contractual agreement with animal keepers that benefits the sale of their products.

(c) It shall not be permissible for persons allowed to supply veterinary medicinal products to solicit or accept any inducement prohibited under sub-regulations 4(a) and 4(b). Provided that existing measures or trade practices relating to prices, profit margins and discounts shall not be affected.

(5) The advertising of a veterinary medicinal product shall:

(a) encourage the rational use of the veterinary medicinal product, by presenting it objectively and without exaggerating its properties;

(b) comply with the particulars listed in the summary of product characteristics;

(c) not be misleading;

(d) be set out in such a way that it is clear that the message is an advertisement and that the product is clearly identified as a veterinary medicinal product;

(e) not give the impression that a veterinary surgeon is unnecessary, in particular by offering a diagnosis or by suggesting treatment by mail, internet or any other means;

(f) not suggests that the effects of administering the veterinary medicinal product are guaranteed, are not accompanied by adverse reactions or are better than, or equivalent to, those of another treatment or veterinary medicinal product;

(g) not suggests that the health of the animal can be enhanced by taking the veterinary medicinal product;

(h) not suggests that the health of the animal could be affected by not taking the veterinary medicinal product provided that this shall not apply to the vaccination campaigns;

(i) not suggests that the veterinary medicinal product is a foodstuff, cosmetic or other consumer product;

(j) not suggests that the safety or efficacy of the veterinary medicinal product is due to the fact that it is natural.

(6) (a)Any advertising of a veterinary medicinal product to persons qualified to prescribe or supply such products shall include:

(i) the trade name;

(ii) a list of active ingredients;

(iii) the pharmaceutical form;

(iv) major indications for use;

(v) the dosage and method of use;

(vi) side effects, warnings, precautions and contraindications;

(vii) the name and address of the marketing authorisation holder;

(viii) any research and/or publications on the use of the active substance.

(b) All the information contained in the documentation referred to in sub-regulation (6)(a) shall be accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the veterinary medicinal product concerned.

(c) Quotations as well as tables and other illustrative matter taken from scientific works for use in the documentation referred to in sub-regulation (9)(a) shall be faithfully reproduced.

(7) (a)Free samples shall be provided on an exceptional basis only to persons qualified to prescribe them and on the following conditions:

(i) each sample shall be no larger than the smallest presentation on the market;

(ii) each sample shall be marked "free sample - not for sale";

(iii) each sample shall be accompanied by a copy of the summary of product characteristics;

(iv) veterinary medicinal products containing psychotropic or narcotic substances as defined under the First Schedule to the Dangerous Drugs Ordinance and the Third Schedule to the Medical and Kindred Professions Ordinance cannot be distributed as samples;

(b) Starter packs shall not be regarded as samples and shall not be labelled as such.

(c) During visits by sales representatives the persons visited should be given information about the use of the veterinary medicinal products, with particular reference to any adverse reactions.

(8) The person who advertises the veterinary medicinal products shall:

(a) keep available for, or communicate to, the Veterinary Services, a sample of all advertisements emanating from his undertaking together with a statement indicating the persons to whom it is addressed, the method of dissemination and the date of first dissemination;

(b) supply the Veterinary Services with the information and assistance it requires to carry out its responsibilities;

(c) ensure that the decisions taken and conditions imposed by the Veterinary Services are immediately and fully complied with.

(9) It is not permissible to advertise veterinary medicinal products which are not registered with the Veterinary Services.