S.L. 437.47 Art. 7ARegistration of veterinary medicinal products according to regulation 7.

(1) In order to be allowed to market the products under regulation 7, a person, herein referred to as the "applicant for the registration of veterinary medicinal product" under regulation 7, shall submit an application to the Veterinary Services.

(2) Upon a reasoned request the Veterinary Services may decide that regulations 60(10) and 60(11) on the legal category of Veterinary medicinal products and regulation 51(4) do not apply to registrations granted under regulation 7.

(3) Before granting such a registration the Veterinary Services may:

(a) request the competent authority in the source country to furnish a copy of the Marketing Authorisation in force;

(b) ensure that the entity applying for a registration in accordance with regulation 7 is a legally established company in the European Union or European Economic Area;

(c) notify the Marketing Authorisation Holder of its intention to grant a registration according to regulation 7 when the Registration Holder is not the same entity as the Marketing Authorisation Holder in the country of source;

(d) request the applicant for a registration in accordance with regulation 7 to furnish an authenticated copy of the Marketing Authorisation in force: Provided that it is not possible for the applicant to provide an authenticated copy of the Marketing Authorisation he shall be requested to provide other proof of an existing Marketing Authorisation in the country of source.

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

(4) The holder of the registration granted in accordance with regulation 7 shall ensure that:

(a) the veterinary medicinal product is in accordance with the current Marketing Authorisation issued in the source country;

(b) notify the veterinary services of any variations to the terms of the Marketing Authorisation approved in the country of source;

(c) there are implemented without any delay actions relating to issues concerning the veterinary medicinal product which have resulted in adverse drug reaction and/or a product or batch recall;

(d) a person is appointed or be himself responsible for the requirements in paragraph (c);

(e) when the applicant is not the Market Authorisation Holder of the product in the source country he shall furnish to the Veterinary Services a letter of access issued by the Market Authorisation Holder granting him the use of the Marketing Authorisation for the purpose of regulation 7: Provided that it is not possible for the applicant to receive a ‘letter of access’ from the Market Authorisation Holder in the country of source the applicant shall be requested to provide proof of the agreement between himself and a duly authorised veterinary wholesale distributor in the country of source;

(f) have a system in place for recording and investigation adverse drug reactions and batch or product defects.