Guidelines on the quality, safety and efficacy of medicinal products for human use catalogue n˚ CO-55-89-843-EN-C, also available in ES, DE, FR, IT Addenda volumes published in July 1990 (n˚ CB-59-90-936- EN-C, also in ES, DE, FR), May 1992 (n˚ CO-75-92-558- EN-C, also in ES, DE, FR, IT) and January 1995 (III/5415/95, not yet published)