EDA Chairman Decree Of year 2020-2021-2022
| About | Issue date | Decree Number |
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Arabic version |
25/08/2020 | EDA Chairman Decree No. (66) of 2020 |
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regarding the rules in inspect of the medical products and devices export procedure subject to the provisions of Law No.( 151) of 2019 |
14/12/2020 | EDA Chairman Decree No. (216) of 2020 |
| EDA Chairman Decree Of year 2021 | ||
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regarding the work by Manufacturing for export System Shall be approved for each of medical products and devices |
07/02/2021 | EDA Chairman Decree No. (69) of 2021 |
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, it is impermissible to establish medical products or devices factories, or adding new production lines to existing factories, except after being formally licensed by EDA |
25/02/2021 | (EDA Chairman Decree No. (99 For Year 2021 |
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regarding to the travel of inspection committees from the Egyptian medicines Authority |
09/11/2021 | EDA Chairman Decree No.( 157) of 2021 |
| regarding The Requirements that shall be met in The Accessory Stores Related to Pharmaceutical Institutions | 25/05/2021 | (EDA Chairman Decree No. (271 For Year 2021 |
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regarding the Regulation of Scientific Offices |
07/07/2021 | (EDA Chairman Decree No. (315 For Year 2021 |
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Arabic version |
14/12/2020 | EDA Chairman Decree No. (340) of 2021 |
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Concerning Issuing the Rules of Biological Products’ Registration Promulgating |
29/07/2021 | (EDA Chairman Decree No. (343 For Year 2021 |
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Arabic version |
23/08/2021 | EDA Chairman Decree No. (394) of 2021 |
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Regarding the Regulatory Procedures for Registering Imported and Local |
12/09/2021 | EDA Chairman Decree No. (429) of 2021 |
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on Data of the Labels of Medical devices, Laboratory, in vitro Diagnostic medical devices, Production Components and |
29/12/2021 | EDA Chairman Decree No. (642 of 2021 |
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Regarding the Guideline |
29/11/2021 | EDA Chairman Decree No. (469) of 2021 |
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Arabic version |
31/10/2021 | EDA Chairman Decree No. (505) of 2021 |
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Regarding the Procedures and Rules of Obtaining Import permit approvals for |
29/11/2021 | EDA Chairman Decree No. (585) of 2021 |
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Arabic version |
2/12/2021 | EDA Chairman Decree No. (590) of 2021 |
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Arabic version |
11/12/2021 | EDA Chairman Decree No. (605) of 2021 |
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Arabic version |
29/12/2021 | EDA Chairman Decree No. (642) of 2021 |
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EDA Chairman Decree Of year 2022 |
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regarding the Regulatory Guidelines for the Importation or Dispatch of Blood Plasma and the Exportation of Finished Plasma Derivatives |
5/1/2022 | EDA Chairman Decree No. (3) of 2022 |
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concerning replacement of the text of article four of the aforementioned Decree of the President of the Egyptian Drug Authority No. (343) of 2021 by the following text |
02/02/2022 | EDA Chairman Decree no.38 of 2022 |
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Regarding the Issuance of Import permit approvals for Medical Devices |
28/02/2022 | EDA Chairman Decree no.88 of 2022 |
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Concerning Approving the Egyptian Guideline for Regulatory Procedures of Good oversight on Clinical Research Practices |
21/02/2022 | EDA Chairman Decree the No. (111) of year 2022 |
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Concerning Guideline of conducting riskbased Post Marketing surveillance plan |
26/02/2022 | EDA Chairman Decree the No. (120) Of year 2022 |
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Arabic version |
26/02/2022 | EDA Chairman Decree the No. (121) Of year 2022 |
| regarding Cosmetics Notification and Trading | 27/02/2022 | EDA Chairman Decree the No. (122) Of year 2022 |
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Inspection teams shall be formed, from the following names, for inspecting the research institutions and relevant entities which conduct the clinical medical research, in order to verify of |
02/03/2022 | EDA Chairman Decree the No. (136) Of year 2022 |
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Concerning the Roles of Rapid Alert System and Recall the |
07/03/2022 | EDA Chairman Decree the No. (146) Of year 2022 |
| Concerning Issuing the Rules of Biological Products’ Registration Promulgating | 14/03/2022 | EDA Chairman Decree the No. (150) Of year 2022 |
| Regarding the Issuance of Import permit Approvals for Medical equipment, their Accessories and their Spare Parts | 04/04/2022 | EDA Chairman Decree the No. (190) Of 2022 |
| Regarding the Enrolling of Proficiency Testing within the Mechanisms of Evaluating Good Laboratory Practices in the Quality Control laboratories the Factories of Pharmaceutical Companies |
12/05/2022 | EDA Chairman Decree No. (273) of 2022 |
| Regarding Accrediting the Quality Control of The Cosmetic Products | 09/06/2022 | EDA Chairman Decree No. (342) of 2022 |
| Regarding the Regulatory Procedures for Registering Local Medical devices not holding International Quality Certificates |
18/07/2022 | EDA Chairman Decree No. (424) Of 2022 |
| the Policy and Rules Regulating the Batches of Biological Products Release President of Egyptian Drug Authority, |
18/07/2022 | EDA Chairman Decree No. (425) Of year 2022 |
| regarding Reorganizing the Rules and Procedures of Re-registration of Veterinary Pharmaceutical Products | 25/07/2022 | EDA Chairman Decree No. (434) Of year 2022 |
| Regarding Extending the Scope of Work and Updating the Egyptian Code for Good Review Methods for Biological, Innovative, Pharmaceutical and Medical Devices | EDA Chairman Decree No. (512) Of 2022 | |
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regarding Issuing the Rules for Registration of Complementary Medical Preparations |
08/09/2022 | EDA Chairman Decree No. (572) Of year 2022 |
| This decree shall be implemented with respect to application of the principle of reliance on reference health authorities in the registration and laboratory testing of imported medical products for human use that have been granted a Certificate of Pharmaceutical Product from one of the reference countries approved by the Technical Committee for Drug Control. |
06/12/2022 | EDA Chairman Decree No. (780) of 2022 |
| Arabic version | 06/12/2022 | EDA Chairman Decree No. (781) of 2022 |
| Arabic version | 06/12/2022 | EDA Chairman Decree No. (783) of 2022 |
| Arabic version | 12/12/2022 | |