Rechtsbibliothek und Fallanalyse · Österreich · Belgien · Europäische Union
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S.L. 458.34 · Medicines (Marketing Authorisation) (S.L. 458.34)

S.L. 458.34 Art. 9Experts to formulate and sign documents.

In KraftAmtlicher Text

(1) The applicant shall ensure that, before the detailed summaries referred to in the regulation 5(3) are submitted to the

Licensing Authority, 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.

(2) Persons having the technical and professional qualifications referred to in the preceding subregulation shall justify any use made of scientific literature under regulation 7(2) in accordance with the conditions set out in Annex I.

(3) The detailed summaries shall form part of the file which the applicant submits to the Licensing Authority.