1. Directive 2001/83/EC of the European parliament and of the council of 6 November 2001 on the community code relating to medicinal products for human use. Official Journal L – 311, 28/11/2004, p. 67–128. http://www.edctp.org/fileadmin/documents/ethics/DIRECTIVE_200183EC_OF_THE_EUROPEAN_PARLIAMENT.pdf.
2. European Pharmacopeia 7.8. Preparations for inhalation: characterization. Chapter 2.9.44, 7.3-3803.
3. European Pharmacopeia 7.8. Preparations for inhalation: aerodynamic assessment of fine particles. Chapter 2.9.18, 274.
4. Committee for medicinal products for human use. Guideline on the pharmaceutical quality of inhalation and nasal products. European Medicines Agency/CHMP/QWP/49313/2005. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003568.pdf.
5. Committee for medicinal products for human use. Guideline on the requirements for clinical documentation for inhaled products (OIP) including the requirements for demonstration of therapeutic equivalence between two inhaled products for the use in the treatment of asthma and chronic obstructive pulmonary disease (COPD). European Medicines Agency/CPMP/EWP/4151/00. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003504.pdf.