Medicines Authority

Awtorità dwar il-Mediċini

EU Legislation

EUR-Lex: European Union Law

http://eur-lex.europa.eu/

Pharmaceuticals

http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm

EudraLex: The Rules Governing Medicinal Products in the European Union.

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/index.htm

EudraLex Volume 1 – Pharmaceutical Legislation

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev1.htm

EudraLex Volume 2 – Notice to Applicants

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev2.htm

EudraLex Volume 3 – Guidelines

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev3.htm

EudraLex Volume 4 – Good Manufacturing Practice

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev4.htm

EudraLex Volume 9 – Pharmacovigilance

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev9.htm

EudraLex Volume 10 – Clinical Trials

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm

Good Distribution Practice Guidelines

http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2001/may/gdpguidelines1.pdf

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