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Submitting comments to AWA

Pursuant to Article 35 section 4 of the Act on the reimbursement of medicinal products, foodstuffs for particular nutritional purposes and medical devices (Polish Journal of Laws No. 122, item 696, as amended), upon completion of the Agency’s Verification Analysis concerning the evaluation of a medicinal product or foodstuff for particular nutritional purposes or a medical device, the President of the Agency shall publish the verification analysis, along with the applicant’s analyses, in the Public Information Bulletin. Comments on these documents may be submitted within 7 days from the publication date.

Comments must be submitted using the form with a Conflict of Interest Statement (CIS), which constitutes an integral part of the form. The submitted comments shall be considered by the Agency and published in the Public Information Bulletin along with the completed CIS. The form and the CIS templates are governed by the order of the Agency’s President.

The Agency reserves that it shall consider only comments submitted by the deadline specified in the Act, i.e. within 7 days. Comments shall only be considered if a signed original copy of the form is submitted. Refer to the President’s Orders for detailed information on the process for collecting and publishing comments along with attachments.