Law of Pharmaceutical and Herbal Establishments and Preparations and its Executive Regulation

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  • Royal Decree No. (M/108) dated 22/8/1441 AH

  •  

  • By the grace of God Almighty

  •                 We Salman bin Abdulaziz Al Saud

  •                                               King of the Kingdom of Saudi Arabia

  • Based onArticle (Seventy) of the Basic Law of Governanceissued by Royal Order No. (A/90) dated 27/8/1412 AH.

  • And based onArticle (Twenty) of the Council of Ministers Lawissued by Royal Order No. (A/13) dated 3/3/1414 AH.

  • And based onArticle (Eighteen) of the Shura Council Lawissued by Royal Order No. (A/91) dated 27/8/1412 AH.

  • After reviewing Shura Council Resolution No. (99/24) dated 18/6/1441 AH

  • And after reviewing Council of Ministers Resolution No. (534) dated 21/8/1441 AH.

  • We decree the following:

    • First: Approval of the Law of Pharmaceutical and Herbal Establishments and Preparations, in the attached form.

    • Second: All existing pharmaceutical establishments shall adjust their status in accordance with the provisions of this law within (one year) from the date of its enforcement.

    • Third: By way of exception to the provisions of Article (Forty-One) of the law, the provisions related to pharmacies and herbal preparation sales establishments stipulated in the Law of Pharmaceutical Preparations and Installations, issued by Royal Decree No. (M/31) dated 1/6/1425 AH, shall continue to apply until the issuance of the specific provisions for these two establishments and their implementation.

    • Fourth: His Highness the Deputy Prime Minister, the Ministers, and the heads of the relevant independent authorities - each within their jurisdiction - shall implement this decree.

    • Salman bin Abdulaziz Al Saud

  •  

  • In the name of God, the Most Gracious, the Most Merciful

  • Council of Ministers Resolution No. (534) dated 21/8/1441 AH

  • The Council of Ministers

  • After reviewing the correspondence received from the Royal Court No. 40013 dated 28/6/1441 AH, including the telegram of His Excellency the Minister of Health No. 2188176-1438 dated 13/8/1439 AH, regarding the draft Law of Pharmaceutical and Herbal Establishments and Preparations.

  • After reviewing the aforementioned draft law.

  • After reviewing the Law of Pharmaceutical Preparations and Installations, issued by Royal Decree No. (M/31) dated 1/6/1425 AH.

  • After reviewing the minutes No. (94) dated 15/2/1436 AH, No. (487) dated 15/8/1436 AH, No. (1391) dated 25/11/1438 AH, No. (530) dated 21/3/1440 AH, No. (1049) dated 9/6/1440 AH, and memoranda No. (1432) dated 28/10/1439 AH, No. (1624) dated 14/9/1440 AH, No. (1633) dated 14/9/1440 AH, No. (555) dated 1/8/1441 AH, prepared by the Bureau of Experts at the Council of Ministers.

  • After reviewing the recommendation prepared by the Council of Economic and Development Affairs No. (39-32/40/D) dated 23/6/1440 AH.

  • After considering Shura Council Resolution No. (99/24) dated 18/6/1441 AH.

  • After reviewing the recommendation of the General Committee of the Council of Ministers No. (5816) dated 13/8/1441 AH.

  • It is decided as follows:

    • First: Approval of the Law of Pharmaceutical and Herbal Establishments and Preparations, in the attached form.

    • Second: All existing pharmaceutical establishments shall adjust their status in accordance with the provisions of this law within (one year) from the date of its enforcement.

    • Third: By way of exception to the provisions of Article (Forty-One) of the law, the provisions related to pharmacies and herbal preparation sales establishments stipulated inthe Law of Pharmaceutical Preparations and Installations, issued by Royal Decree No. (M/31) dated 1/6/1425 AH, shall continue to apply until the issuance of the specific provisions for these two establishments and their implementation.

  • A draft Royal Decree has been prepared, its text is attached hereto.

  • Prime Minister

 

Article 1

  • In this Law, the following words and phrases shall have the meanings assigned thereto, unless the context requires otherwise:

    • Law: Law of Pharmaceutical and Herbal Establishments and Preparations. Authority: Saudi Food and Drug Authority.

    • Board: Board of Directors of the Authority.

    • CEO: Chief Executive Officer of the Authority.

    • Pharmacist: A person holding a bachelor's degree in pharmaceutical sciences or a doctor of pharmacy degree from a college of pharmacy in the Kingdom, or their equivalent. Pharmacy

    • Technician: A person holding a pharmacy technician degree from a health institute or college in the Kingdom, or its equivalent.

    • Pharmaceutical Preparation (Medication): A pharmaceutically manufactured product which contains one or more substances used externally or internally in the treatment or prevention of human diseases.

    • Herbal Preparation: Any plant or herb with therapeutic claims that is pharmaceutically prepared.

    • Counterfeit Pharmaceutical or Herbal Preparation: A preparation the content, identity, or source of which is intentionally altered with the intent to deceive, even if the ingredients remain the same, including preparations with trademarks and generic marks. A pharmaceutical or herbal preparation shall be deemed counterfeit if it is contaminated; contains contaminated, incorrect, inactive, or ineffective ingredients; does not contain active ingredients; or is packed in counterfeit packages.

    • Spoiled Pharmaceutical or Herbal Preparation: A preparation the properties of which have changed, rendering it unfit for use.

    • Pharmaceutical Establishment: Any pharmaceutical and herbal preparations factory or wholesale warehouse, scientific office, or medicinal consultation or pharmaceutical and herbal preparations analysis center.

    • Pharmacy: An establishment where pharmaceutical and herbal preparations are prepared and dispensed or sold. Pharmaceutical and Herbal Preparations

    • Wholesale Warehouse: A pharmaceutical establishment which imports, distributes, or sells pharmaceutical and herbal preparations wholesale.

    • Scientific Office: A pharmaceutical establishment which provides scientific, technical, and marketing information on pharmaceutical and herbal preparations in the Kingdom.

    • Herbal Preparations Outlet: An establishment where herbal preparations are prepared and sold.

    • Medicinal Consultation or Pharmaceutical and Herbal Preparations Analysis Center: A pharmaceutical establishment that provides medicinal consultations, analyzes pharmaceutical and herbal preparations, conducts bioavailability and bioequivalence studies, controls the quality of medicines, and determines drug levels in biological fluids

    • Regulations: Implementing Regulations of this Law.

Article 2

  • A pharmaceutical establishment shall not operate without obtaining the required license from the Authority in the name of its owner.

Article 3

  • A medicinal consultation or pharmaceutical and herbal preparations analysis center shall meet the following licensing conditions:

    • 1. The director is a full-time pharmacist licensed to practice the profession.

    • 2. The center complies with the conditions and specifications specified by the Regulations.

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Article 4

  • A pharmaceutical and herbal preparations wholesale warehouse shall meet the following licensing conditions:

    • 1. The director is a full-time pharmacist or pharmacy technician licensed to practice the profession.

    • 2. The warehouse complies with the conditions and specifications specified by the Regulations.

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Article 5

  • A pharmaceutical and herbal preparations factory shall meet the following licensing conditions:

    • 1. An industrial license is obtained from the competent authority.

    • 2. The technical director is a full-time Saudi pharmacist licensed to practice the profession.

    • 3. The factory complies with the conditions and specifications specified by the Regulations.

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Article 6

  • Each company or sole proprietorship manufacturing pharmaceutical or herbal preparations, which has a factory registered in the Kingdom, shall have a scientific office. A scientific office shall meet the following licensing conditions:

    • 1. The director is a full-time Saudi pharmacist licensed to practice the profession.

    • 2. The office complies with the conditions and specifications specified by the Regulations.

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Article 7

  • The license term of a pharmaceutical establishment shall be five renewable years.

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Article 8

Article 9

  • A pharmaceutical establishment may not hire pharmacists, pharmacy technicians, or other health practitioners unless they are licensed to practice the profession.

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