European regulations relevant to the marketing and use of fish vaccines

In the Member States of the European Union (EU), vaccines cannot be marketed unless a marketing authorisation has been granted for the product by the relevant competent authority, and there are similar requirements in other European countries, such as Norway. The legal basis of this control in EU Member States is through the national implementation of the various directives and regulations, principally Council Directive 81/851/EEC as amended and Council Regulation (EEC) 2309/93. This Regulation also provides the framework for the decentralised system for authorisation of products in more than one member state and for the centralised procedure for authorisation in all of the countries of the EU. Council Directive 81/852/EEC as amended and EU guidance notes set out requirements for the quality, safety and efficacy of the vaccines. Only products which conform with the requirements can now be given an authorisation for marketing in a Member State, and all existing vaccines must be shown to conform by April 1998. Requirements for vaccines are also included in the monographs of the European Pharmacopoeia, which set legally binding standards for products on the market in Europe. Monographs for various types of fish vaccines are now being elaborated. In addition to control through marketing authorisations, a number of European countries have a system for official control of each batch which is to be released for sale. Distribution and supply of the products are also subject to controls. The system used varies from country to country but, for example, in some countries vaccines can only be supplied on receipt of a prescription from a veterinary surgeon. Thus, the marketing and use of fish vaccines are subject to a series of regulations which must be addressed by any company wishing to supply such products in Europe.