ABSTRACT
In May and June 1989, the Council of Ministers adopted four new Directives extending the scope of the existing pharmaceutical Directives to include products previously excluded from their scope under Article 34 of Directive 75/319/EEC. These products were previously exempted because it was felt that the existing provisions of 75/318/EEC (the ‘norms and protocols’ Directive) and 75/319/EEC (the administrative and general provisions Directive) would need adaptation to their special requirements. The new Directives adopted in 1989 are collectively called the ‘extension Directives’.
