RLD Requirement in all EU region [Regulatives / Guidelines]

posted by Dr_Dan  – Germany, 2013-06-03 11:08 (4771 d 11:05 ago) – Posting: # 10711
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Dear Compliance
  1. The product used as reference product in the bioequivalence study should be part of the global marketing authorisation of the reference medicinal product (as defined in Article 6(1) second subparagraph of Directive 2001/83/EC). The selection of the reference product used in a bioequivalence study should be based on assay content and dissolution data and is the responsibility of the Applicant.
  2. In theory you have to perform a BE study with reference product marketed in Australia. In praxis it often is sufficient if you give evidence that the European product is the same as the Australian (qualitative and quantitative composition) and you can use the European BE study.
  3. Romania, Netherlands, Poland = EU, Switzerland non-EU but associated, Malaysia, Philippines, Indonesia, Vietnam = Asia with own regulations.
Kind regards
Dan

Edit: Document linked. [Helmut]
—
Kind regards and have a nice day
Dr_Dan

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