Guidelines-for-the-preparation-and-distribution-of-traditional-Galenic-medicines-in-pharmacies-Irann
Guidelines-for-the-preparation-and-distribution-of-traditional-Galenic-medicines-in-pharmacies-Irann
Guideline for the Preparation and Supply of Galenic Medicines in Pharmacies
The "Guideline for the Preparation and Supply of Galenic Medicines in Pharmacies" was published in 2023 by the General Administration of Natural, Traditional, and Complementary Products of the Food and Drug Organization and becomes enforceable as of September 22, 2024. Its key content is as follows:
Objective: To organize and implement the method for preparing and supplying traditional Galenic medicines in pharmacies, to expand the use of these products, and to establish a unified procedure across the country.
Scope of Application: Includes simple or compound traditional medicines with herbal, mineral, or animal bases, which are prepared by the technical manager of the pharmacy with the approval of relevant specialists.
Responsibilities:
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Scientific and technical responsibility lies with the technical manager of the pharmacy.
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Supply of the product is only permitted with the presence and approval of the technical manager.
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Supervision of the supplying units is the responsibility of the Food and Drug Deputy of the Universities of Medical Sciences.
Implementation Conditions:
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The pharmacy must have a separate preparation unit equipped with appropriate sanitary conditions.
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Raw materials must be sourced from reliable suppliers and stored under suitable conditions.
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Labeling of medicines must include information such as the patient's name, the medicinal formula, administration instructions, and the expiry date.
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The expiry date of the medicines is set for a maximum of one month, determined at the discretion of the technical manager.
This guideline is established based on the approved laws of the Ministry of Health and the Food and Drug Organization and is mandatory for specialists in Traditional Persian Medicine, pharmacists, and technical managers of pharmacies.
The complete files of the guideline are available for download at the bottom of this page (below the dashed line).
What is its difference from the "Regulation on the Preparation and Supply of Traditional Persian Medicine Products" in pharmacies? (Refer to the table below)
| Subject | Galenic Instructions | Traditional Medicine Products Regulation |
|---|---|---|
| Scope of Application | Focuses on traditional Galenic medicines (prepared in pharmacies by the technical manager). | Includes all Traditional Medicine products (herbal, mineral, animal) for production in factories and pharmacies. |
| License Conditions | Requires approval from the pharmacy's technical manager and compliance with specific conditions for preparation within the pharmacy. | License for pharmacists with 10 years of experience in Traditional Medicine and approval from the Council for the Review of Herbal Medicines. |
| Labeling | Mandatory inclusion of the patient's name, administration instructions, warnings, and a maximum expiry date of 1 month. | Inclusion of "Iranian Traditional Medicine Product," manufacturer's name, production/expiry date, and general administration instructions. |
| Expiry Date | Maximum of 1 month (emphasizing the instability of Galenic preparations). | Expiry date depends on the product type and Ministry of Health approval (generally longer). |
| Reference Sources | List of 31 reference books (including various pharmacopoeias (Qarabadin) and lesser-known texts). | List of 10 main books (such as Avicenna's Canon, Al-Hawi, and Zakhireh Kharazmshahi). |
| Production Limitations | Prohibition of mass production and storage; only for direct patient consumption. | Possibility of workshop/industrial scale production with Ministry of Health license. |
| Preparation Conditions | Requires a separate preparation unit within the pharmacy with specific equipment (scales, water bath, filter paper). | Emphasis on formulation compliance with reference books and quality control of raw materials. |
The complete files of the guideline are available for download at the bottom of this page (below the dashed line).
ادمین انجمن علمی طب سنتی ایران
