S.L. 437.95 Art. 48Vaccination.

(1) Vaccination against the exotic diseases listed in Part II

of Schedule IV shall be prohibited unless such vaccination is approved in accordance with rules 41, 42, 44 or 47.

(2) Vaccination against the non-exotic diseases listed in Part II of Schedule IV shall be prohibited in any part of the territory of Malta declared free of the diseases in question in accordance with rules 49 or 50, or covered by a surveillance programme, approved in accordance with rule 44(1): Provided that vaccination in parts of the territory of Malta which have not declared free from the diseases in question may be permitted or where vaccination is a part of an eradication programme approved in accordance with rule 44(2).

(3) The vaccines must be authorised in accordance with Directive 2001/82/EC and Regulation (EC) No. 726/2004.

(4) Sub-rules (1) and (2) shall not apply to scientific studies for the purpose of developing and testing vaccines under controlled conditions and during such studies, the appropriate measures shall be taken to protect other aquatic animals from any adverse effect of the vaccination carried out within the frame-work of the studies.

CHAPTER VII

Disease-Free Status