Bioequivalence and Bioavailability Forum

Dear all
Is it mandatory that the clinical overview (Modul 2.5 of the dossier) is signed by a physician? In fact most medical writers (at least here in Germany) are biologists.
According to article 12 Directive 2001/83/EC
1. The applicant shall ensure that, before the detailed summaries referred to in the last subparagraph of Article 8(3) are submitted to the competent authorities, they have been drawn up and signed by experts with the necessary technical or professional qualifications, which shall be set out in a brief curriculum vitae.
No physician demanded. The same holds true for the German Drug Law §24(3) AMG. The British MHRA insists of having the expert statement signed by a physician without having any objections against the quality of the statement written by a biologist. Is there any legal basis for this demand?
Looking forward to your replies.
Kind regards
Dan