eudralex eudralex eudralex is the collection of rules and regulations governing medicinal products in the european union. this article is part of a series onpolitics of the european union member states (27) austria belgium bulgaria croatia cyprus czech republic denmark estonia finland france germany greece hungary ireland italy latvia lithuania luxembourg malta netherlands poland portugal romania slovakia slovenia spain sweden candidate countries albania bosnia and herzegovina moldova montenegro north macedonia serbia turkey ukraine applicant countries georgia kosovo special territories france–germany relations germany–netherlands relations eu 3 withdrawal from the european union treaties and declarations schuman declaration (1950) treaty of paris (1951) europe declaration (1951) treaty of rome (1957) euratom treaty (1957) merger treaty (1965) solemn declaration (1983) single european act (1986) maastricht treaty (1992) treaty of amsterdam (1997) treaty of nice (2001) berlin 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china–european union relations european union–nato relations iceland–european union relations norway–european union relations russia–european union relations switzerland–european union relations turkey–european union relations ukraine–european union relations united kingdom–european union relations (history) post-brexit united kingdom relations with the european union brexit united states–european union relations common travel area (ireland) microstates and the european union european union and the united nations european union association agreement g7 g20 defunct bodies european communities (1958–1993) european coal and steel community european economic community european community western european union convention on the future of europe european union portal other countries volumes eudralex consists of 10 volumes: concerning medicinal products for human use: volume 1 - pharmaceutical legislation. volume 2 - notice to applicants. volume 2a deals with procedures for marketing authorisation. volume 2b deals with the presentation and content of the application dossier. volume 2c deals with guidelines. volume 3 - guidelines. concerning medicinal products for human use in clinical trials (investigational medicinal products). volume 10 - clinical trials. concerning veterinary medicinal products: volume 5 - pharmaceutical legislation. volume 6 - notice to applicants. volume 7 - guidelines. volume 8 - maximum residue limits. concerning medicinal products for human and veterinary use: volume 4 - good manufacturing practices. volume 9 - pharmacovigilance. miscellaneous: guidelines on good distribution practice of medicinal products for human use (94/c 63/03) directives directive 65/65/eec1, requires prior approval for marketing of proprietary medicinal products directive 75/318/eec, clarifies requirements of 65/65/eec1 and requires member states to enforce them directive 75/319/eec, requires marketing authorization requests to be drawn up only by qualified experts directive 93/41/eec, establishes the european agency for the evaluation of medicinal products directive 2001/20/ec, defines rules for the conduct of clinical trials directive 2001/83/ec directive 2005/28/ec, defines good clinical practice for design and conduct of clinical trials