Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 146 — Article (146) License Cancellation

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

1. The Competent Health Establishment or Authority, each within the limits of their jurisdiction, may issue a decision to cancel the Biobank license, in any of the following cases: a. The Biobank is carrying out an unlicensed activity. b. If it is proven that obtaining the license to open the Biobank was the result of submitting forged documents or incorrect data or information. c. The Biobank remains closed for a period exceeding (3) three consecutive months without an excuse acceptable to the EDE or the Competent Health Authority, each within the limits of their jurisdiction. d. Failure to start work in the Biobank within (6) six months from the date of licensing to open it without an acceptable excuse from the EDE or the Competent Health Authority, each within the limits of their jurisdiction. e. Repeating or not removing the violations mentioned in Article (145) of this Law within the period specified by the Ministry or the Competent Health Authority, each within the limits of their jurisdiction. f. Committing the prohibitions mentioned in Clauses (2) of Article (144) of this Decree-Law. g. Committing a violation that requires the License Cancellation of the Biobank, as determined by the Executive Regulations of this Decree-Law or the local legislation in force in this regard. 2. In the event of license cancellation 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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