Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 95 — Article (95) Prohibitions

Part Seven: Licence of Pharmaceutical Establishments and Biobanks · Chapter Two: Licence to Open a Compound Pharmacy

The Compound Pharmacy is prohibited from the following: 1. Practicing any activity not licensed. 2. Dealing with other unlicensed Pharmaceutical Establishments. 3. The installation of Medical Products shall not commence until after obtaining the certificate referred to in Paragraph (a) of Clause (2) of Article (92) of this Decree-Law. 4. Commencing the installation of Medical Products that are essentially copies of Medical Products that have a valid Marketing Approval from the EDE, unless there is no commercially available Medical Product that can achieve the expected direct benefit to the patient health, and similar results could not be obtained by other means. 5. Compounding Pharmacies may not conduct any activities related to improvised, unstudied formulations or the extraction process of medicines and preparations derived from natural sources, and it is not permitted to formulate a Medical Product prepared for research, development or experimentation. 6. Any other prohibitions contained in the Executive Regulations of this Decree-Law or in the local legislation in force in this regard. The Owner of the Compound Pharmacy and the Pharmacist in charge shall be responsible for violating the provisions of this Article.

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