1. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Bioequivalence Centre, in any of the following cases: a. Withdraw or cancel or. Failure to renew the Good Clinical Practice and/or Good Laboratory Practice certificate. b. Transferring Ownership of a Bioequivalence Centre to another person without the approval of the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. c. Transferring Ownership of Bioequivalence Centre to another person without the approval of the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. d. The absence of qualified persons for direct supervision and control in accordance with the rules in force in this field. e. Proof that the Bioequivalence Centre has used forged documents and papers while practicing their licensed activities. Committing the prohibitions mentioned in Clauses (4) of Article (156) of this Decree-Law. f. Committing a violation that requires the license suspension of Bioequivalence Centre, as determined by the Executive Regulations of this Decree-Law or the local legislation in force in this regard. 2. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue an immediate decision to close the Bioequivalence Centre as precaution if its continued operation poses a risk to public health or results from its commission of violations that require precautionary closure, as determined by the Executive Regulations of this Decree-Law or the local legislation in force in this regard. 3. In all cases, the matter must be referred to the EDE Pharmaceutical Practices Control Committee or the committee referred to in Clause (2) of Article (160) of this Decree-Law, as the case may be, within (7) seven working days from the date of temporarily suspending the license or Precautionary closure to consider and decide on disciplinary responsibility, within a period not exceeding (10) ten working days from the date the matter is referred to it.
Interpretation and application must be checked against the official text and current version.