S.L. 437.115 Art. 8Registration in accordance with Article 116 of Regulation (EU) 2019/6.

(1) Before the placing on the market of any veterinary medicinal product as established by Article 116 of Regulation (EU)

2019/6, a person shall register every veterinary medicinal product with the Director in the manner provided by him and shall pay the relevant fee.

(2) Before approving the registration, the Director may:

(a) request the competent authority in the country of source to furnish a copy of the current marketing authorisation;

(b) ensure that the entity applying for a registration in accordance with Article 116 of Regulation (EU) 2019/6 is a legally established company in the European Union or European Economic Area;

(c) notify the marketing authorisation holder of his intention to grant a registration in accordance with Article 116 of Regulation (EU) 2019/6 when the applicant is not the same entity as the marketing authorisation holder in the country of source;

(d) request the applicant to furnish a copy of the current marketing authorisation:

Provided that when it is not possible for the applicant to provide a copy of the current marketing authorisation, he shall be required to provide alternative evidence that the product is being marketed in the country of source;

(e) request from the applicant data on the impact of the product on the environment in the territory of Malta;

(f) request the applicant to furnish a letter of access issued by the market authorisation holder granting him the use of the marketing authorisation for the purposes of Article 116 of Regulation (EU) 2019/6:

Provided that when it is not possible for the applicant to obtain a letter of access from the market authorisation holder, the applicant may be requested by the Director to provide evidence that due diligence has been exercised to ensure that the veterinary medicinal products were obtained from a duly authorised supplier of veterinary medicinal products in the country of source; and

(g) ensure that the applicant has a system in place for the recording and investigation of adverse drug reactions and defects in a batch or veterinary medicinal product.

(3) After registration in accordance with this regulation, the registration holder shall ensure that:

(a) the veterinary medicinal product is kept in line with the marketing authorisation issued in the country of source for as long as the registration remains valid;

(b) the Director is notified of any variation to the terms of the marketing authorisation approved in the country of source that affects the summary of the products’ characteristics, the package leaflet, the packaging, the labelling and any change in administrative details that may have been made after the original registration;

(c) any action relating to adverse drug reaction and, or a product or batch recall shall be implemented without delay; and

(d) he is responsible for the requirements in paragraph (c), or appoints another person for such purpose.

(4) By way of derogation from Article 2(1) and (2) of the Regulation (EU) 2019/6, only Articles 57, 94, 117, 119, 123 and 134 of Regulation (EU) 2019/6 shall apply to veterinary medicinal products registered in accordance with Article 116 of Regulation (EU) 2019/6.

(5) The registration granted in accordance with this regulation shall be valid for a period of three (3) years.