November 2018: Greece Regulatory Update

Submission of supporting documents in electronic form as of 1 December 2018:

To simplify the procedures for submitting applications for initial approvals as well as clinical trial modifications to the Department of Clinical Trials of the EOF regarding the supporting documents in Annex I of the Ephoracy Circular with AP. 88148 / 23.12.2010, please as of 1.12.2018 all the supporting documents are submitted in electronic form (aggregated in 1 CD). Additionally, the following documents should be submitted in hard copy (original).

  1. Cover Letter of Initial Application (PFME-E.4200-2)
  2. Clinical trial application form in Greek (ΔΦΜΕ-Ε.4200-1 or ΔΦΜΕ-Ε.4200-3)
  3. Fee, provided it has been issued by the Bank of Greece

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