ANNEX

Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products · European Union

The expression "vaccines, toxins or serums" used in Article 34 shall cover in particular: - agents used to produce active immunity (such as cholera vaccine, BCG, polio vaccine, smallpox vaccine); agents used to diagnose the state of immunity including in particular tuberculin and tuberculin PPD, toxins for the Schick and Dick Tests, brucellin; agents used to produce passive immunity (such as diphtheria antitoxin, anti-smallpox globulin, antilymphocytic globulin).

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.