S.L. 437.115 Art. 4Package leaflet. Exemptions from marketing authorisation.

The package leaflet of a veterinary medicinal product may be made available on paper, electronically, or both of them.

a 5. (1) For the purposes of Article 5(6) of Regulation

(EU) 2019/6, the applicant shall submit an application in the form provided for by the Director and shall pay the established fee:

Provided that the veterinary medicinal product shall only be placed on the market when the authorisation is issued by the Director.

(2) The exemption stipulated under Article 5(6) of Regulation (EU) 2019/6 shall only be granted at the discretion of the Director.

(3) The holder of an authorisation in accordance with this regulation shall notify the Director within fifteen (15) days of becoming aware of any adverse reaction and shall keep records of such incidents:

Provided that the records provided for in this regulation shall be kept by a holder of an authorisation in accordance with this regulation for five (5) years and shall be made available to the Director upon his request.

(4) The Director may publish a list of active substances that may be used in veterinary medicinal products authorised in accordance with this regulation. This list shall specify the species of non-food producing animals for which the active substances are approved. This list may also specify the manner in which the product containing the active substances are to be administered.

(5) The Director may reject an application or may suspend and, or revoke the authorisation granted in accordance with this regulation if any one (1) or more of the following occur:

(a) adverse reactions are reported and confirmed;

(b) it is demonstrated, at any time after authorisation, that the risk-benefit is unfavourable;

(c) the product contains active substances that are re-classified as narcotic or psychotropic drugs;

(d) any one (1) of the ingredients in the product is not included anymore in the list of active substances mentioned in sub-regulation (4); and

(e) it is reported and is verified by the Director that the product is not being used on animals as established in Article 5(6) of Regulation (EU) 2019/6.

(6) The products authorised under this regulation shall be labelled with the following:

(a) the name of the veterinary medicinal product;

(b) the pharmaceutical form;

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

(d) the route of administration;

(e) the batch number;

(f) the expiry date;

(g) a statement to the effect of "For administration on non-food producing animals only. Veterinary medicinal product authorised in accordance with Article 5(6) of Regulation (EU) 2019/6";

(h) the target species;

(i) storage instructions, if applicable;

(j) therapeutic indications, if applicable;

(k) contra-indications, if applicable; and

(l) interaction with other medicines and other forms of interaction, if applicable.

(7) The authorisation granted in accordance with this regulation shall be valid for a period of five (5) years.