Specifically, a trial project utilizing a post-marketing notification approach to product registration should be implemented and evaluated for a limited number of ONHP-approved attestable monographs. |
Non-attestable monographs for higher risk products, or for lowerrisk products which do not lend themselves to the attestable monograph process, can also be created as knowledge is acquired. |
The ONHP may also adopt, by reference, existing monographs which meet the requirements for an attestable monograph. |
In the case of lower risk products, the proposed product licensing system will rely, in part, on ONHP-approved, attestable monographs, which will form the basis for an abbreviated premarket process. |
Suffering as the attestable key to imaginative existence. |
The Transition Team recognizes that there may be an opportunity to create an ONHPapproved, attestable monograph, or amend existing ones, for the clinically-proven claim of a lower-risk product. |