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Submitting comments to AWA

In accordance with Article 35 (4) of the Act on reimbursement of medicines, foodstuffs for particular nutritional uses and medical devices (Journal of Laws No. 122,item 696, as amended), upon completion of work on the Agency’s verification analysis on the evaluation of a medicine or a foodstuff for particular nutritional uses or a medical device, the President of the Agency publishes the verification analysis together with the applicant’s analysis in the Public Information Bulletin. Comments may be submitted to these documents within 7 days of publication.

Persons who submit comments are required to present them on a form, of which the Declaration of Conflict of Interest (DKI) is an integral part. Submitted comments are reviewed by the Agency and posted on the Public Information Bulletin together with the completed DKI. The template of the form and the DIC is regulated by an order of the President of the Agency.

The Agency stipulates that it will consider only those comments which are submitted within the deadline specified in the Act, i.e. 7 days. The condition for the consideration of comments is the submission of the signed original form. Detailed information on the process of collecting and publishing comments, along with attachments, is contained in the President’s Orders.