Article 48 Vaccination

Member States shall ensure that vaccination against the exotic diseases listed in Part II of Annex IV is prohibited unless such vaccination is approved in accordance with Articles 41, 42 or 47.

Member States shall ensure that vaccination against the non-exotic diseases listed in Part II of Annex IV is prohibited in any parts of their territory declared free of the diseases in question in accordance with Article 49 or 50, or covered by a surveillance programme, approved in accordance with Article 44(1).

Member States may allow such vaccination in parts of their territory not declared free from the diseases in question, or where vaccination is a part of an eradication programme approved in accordance with Article 44(2).

Member States shall ensure that the vaccines used are authorised in accordance with Directive 2001/82/EC and Regulation (EC) No 726/2004.

Paragraphs 1 and 2 shall not apply to scientific studies for the purpose of developing and testing vaccines under controlled conditions.

During such studies, Member States shall ensure that the appropriate measures are taken to protect other aquatic animals from any adverse effect of the vaccination carried out within the framework of the studies.