Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 145 — Article (145) License Suspension and Precautionary Closure

Part Seven: Licence of Pharmaceutical Establishments and Biobanks · Chapter Nine: Biobank Licensing

1. The EDE or the Competent Health Authority, each within their jurisdiction, shall issue a decision to temporarily suspend the License of the Biobank, in any of the following cases: a. Transferring Ownership of a Biobank to another person without the approval of the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. b. Transferring Ownership of a Biobank to another place without the approval of the EDE or the Competent Health Authority, each within the limits of their jurisdiction. c. The absence of qualified persons for direct supervision and control in accordance with the rules in force in this field. d. Proof that the Biobank has used forged documents and papers while practicing their licensed activities. e. Committing the prohibitions mentioned in Clauses (3) of Article (144) of this Decree-Law. f. Committing a violation that requires the Temporary Closure of the Biobank, 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 Biobank 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 shall be referred to the committee referred to in Clause (2) of Article (160) of this Decree-Law, within (7) seven working days from the date of the Temporary Closure of the General Pharmacy, to consider it and decide on disciplinary responsibility, within a period not exceeding (10) ten working days from the date of referring the matter to it. 4. In the event of a precautionary closure or temporary suspension of the Biobank, it shall take the necessary measures under the supervision of the Competent Health Establishment or Authority, each within their jurisdiction, to ensure that the biological samples stored therein will be transferred to another Establishment or Establishments licensed within the State to store biological samples.

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