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Which form can be used to apply for marketing authorisation of a homeopathic product with indications?

Applications for marketing authorisation of specific homeopathic products (i.e. homeopathic products with indications) can be lodged using the application form available on the EudraLex website, as Section 28a of the amended Act on Pharmaceuticals (No. 378/2007 Sb.) requires the same form for submitting of the application as Article 16 of Directive e 2001/83/EC (marketing authorisation procedure).

http://ec.europa.eu/health/files/eudralex/vol-2/b/applicformhomeo_2005_12_en.pdf