Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 132 — Article (132) License Cancellation

Part Seven: Licence of Pharmaceutical Establishments and Biobanks · Chapter Seven: Licensing Medical Product Factories and Contracting Companies Manufacture Medical Products

The EDE shall issue a decision to temporarily cancel the License of Medical Product Factories and Contracting Companies Manufacture Medical Products, in any of the following cases: 1. The factory or contracting company is carrying out an activity for which it is not licensed. 2. If it is proven that obtaining the license to open the Factory or Contracting Company or obtaining marketing approval for Medical Products was the result of submitting forged documents or incorrect data or information. 3. The Factory or Contracting Company remain closed for a period exceeding (3) three consecutive months without an excuse acceptable to the EDE. 4. Failure to commence work in the Factory or Contracting Company within (6) six months from the date of the License to open it without an excuse acceptable to the EDE. 5. Repeatedly performing the activity in a manner that contravenes the standards and instructions of good manufacture practice. 6. Repeating or not removing the violations mentioned in Article (131) 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 (130) of this Decree-Law. 8. Any other cases that require cancellation of the license of the Factory or Contracting Company as determined by the Executive Regulations of this Decree-Law.

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