The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to cancel the License of the Non-Clinical and Clinical Research Entity, in any of the following cases: 1. The Non-Clinical and Clinical Research Entity is engaged in an activity for which it is not licensed. 2. If it is proven that obtaining the license to open a Non-Clinical and Clinical Research Entity was the result of submitting forged documents or incorrect data or information. 3. The Non-Clinical and Clinical Research Entity remains closed for a period exceeding (3) three consecutive months without an excuse acceptable to the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 4. Failure to start work in the Non-Clinical and Clinical Research Entity within (6) six months from the date of licensing to open it without an acceptable excuse from the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 5. Repeatedly engaging in an activity in a manner that contravenes relevant good practice standards and instructions. 6. Repeating or not removing the violations mentioned in Article (151) of this Law within the period specified by the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. 7. Committing the prohibitions mentioned in Clauses (3-2) of Article (150) of this Decree-Law. 8. Committing a violation that requires cancellation of the Non-Clinical and Clinical Research Entity, as determined by the Executive Regulations of this Decree-Law or the local legislation in force in this regard.
Interpretation and application must be checked against the official text and current version.
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