S.L. 437.115 Art. 20Samples or demonstration packs.

(1) For the purposes of Article 119(1) and (9) of

Regulation (EU) 2019/6, veterinary medicinal products may be exempted from the requirements established by Article 5 of Regulation

(EU) 2019/6 if these are intended to be used as samples and, or as demonstration packs that are given directly to veterinary surgeons or other persons who are allowed to supply veterinary medicinal products during sponsored events by pharmaceutical companies or during professional visits to those persons who are authorised to prescribe or dispense veterinary medicinal products:

Provided that this exemption shall be granted by the Director following a request from the wholesale distributor of veterinary medicinal products in the manner indicated by the Director before the activity takes place, and the exemption shall not be used before the product has been registered.

(2) The Director shall only register the product when:

(a) the veterinary medicinal products are labelled with the following words "Free sample - Not for sale" or "Demonstration pack - Not for sale", as the case may be;

(b) each sample or demonstration pack shall not be bigger than its smallest presentation on the market;

(c) each sample or demonstration pack shall be accompanied by a copy of the summary of product characteristics;

(d) veterinary medicinal products containing psychotropic or narcotic drugs cannot be distributed as samples or demonstration packs;

(e) starter packs shall not be regarded as samples and shall not be labelled as such;

(f) 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 reaction;

(g) the information provided with the samples or demonstration packs shall not be promotional in nature;

(h) the applicant shall be a holder of a wholesale distribution authorisation; and

(i) the validity period of the authorisation shall be one

(1) year from the first consignment thereof.

(3) If any veterinary medicinal product registered in accordance with this regulation is administered on a food producing animal, that animal shall be excluded permanently from the food chain.