1. Reasons for Proposal
This Amendment prescribes application and processing procedures for the newly introduced temporary permission and prompt identification systems and clarifies standards for examination.
It also expands the scope of applications for regulatory exemptions for demonstration so as to allow companies to which a technology has been transferred to file an application on their own, thereby aiming to improve availability for users of the system.
It maximizes the effectiveness of improvements to regulations through regulatory exemptions by clarifying the procedures and required documents for requesting modifications of the law and newly inserts a procedure for requesting re-deliberation in the event that a regulatory exemption is rejected, thereby protecting the rights and interests of regulatory exemption applicants.
2. Major Provisions
A. Expand the eligibility for regulatory exemptions for demonstration (Article 19-2 (1))
The current Decree only allows public research institutes to apply for regulatory exemptions for demonstration, which means that it has not been possible for companies to demonstrate a new technology independently. The Amendment addresses this by expanding the eligibility for regulatory exemptions for demonstration to include public research institutes, companies to which a technology has been transferred, advanced technology enterprises, professional research businesses, etc.
B. Newly insert an application procedure for re-deliberation for regulatory exemptions for demonstration (Article 19-3 (3) through (6))
Prescribe relevant procedures to allow a person who intends to demonstrate a new technology to apply for re-deliberation in the event that their application for regulatory exemption for demonstration is not approved, and allow opinions to be heard from subject matter experts with professional knowledge and experience upon re-deliberation.
C. Newly insert procedures for requesting modifications to the law (Article 19-9)
Newly insert relevant procedures to allow requests for modifications to the relevant laws when a technology is under demonstration with regulatory exemptions or when demonstration is complete and safety has been established. Clarify the standards for examination for modifications to the law, such as benefit to users, any safety accidents or damages, ripple effects and expected effects, conflicts and mediation between interested parties, etc.
D. Newly insert application procedures, standards for examination, etc. for prompt identification and temporary permission (Articles 19-15 through 19-20)
Clarify the required documents, handling procedure, valid term, etc. of applications for prompt identification and temporary permission. Improve predictability for applicants by prescribing detailed standards for examination, such as business plans, financial and technical capabilities of the applicant, benefit to users, and the validity of means to protect users.
