Overview of global regulatory toxicology requirements for vaccines and adjuvants

Author:

Sun Yuansheng,Gruber Marion,Matsumoto Mineo

Publisher

Elsevier BV

Subject

Pharmacology,Toxicology

Reference23 articles.

1. COMMISSION DIRECTIVE 2003/63/EC of 25 June 2003 amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;Official Journal L,2003

2. Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products (OJ L No 22 of 9. 2. 1965, p. 369) ((As amended by Directives 66/454/EEC, 75/319/EEC, 83/570/EEC, 87/21/EEC, 89/341/EEC 89/342/EEC 89/343/EEC, 92/27/EEC, 92/73/EEC et 93/39/EEC).

3. Council Directive 75/318/EEC of 20 May 1975 on the approximation of the laws of Member States relating to analytical, pharmaco-toxicological and clinical standards and protocols in respect of the testing of proprietary medicinal products;Official Journal L,1975

4. Council Directive 89/342/EEC of 3 May 1989 extending the scope of Directives 65/65/EEC and 75/319/EEC and laying down additional provisions for immunological medicinal products consisting of vaccines, toxins or serums and allergens;Official Journal L,1989

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