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Date: 26-Jul-2024 Category: Extra Ordinary State: Union Government Country: India

In pursuance of Sub rule 1 of Rule 15 of the Bureau of Indian Standards Rules

Issued by Bureau of Indian Standards · Not Applicable

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Executive Summary & Key Takeaways

Gazette Notification Description

  • This gazette notification from the Bureau of Indian Standards (BIS), dated July 26, 2024, announces amendments to Indian Standard IS/ISO 11615:2017.
  • The amendment pertains to 'Health Informatics — Identification of Medicinal Products — Data Elements and Structures for the Unique Identification and Exchange of Regulated Medicinal Product Information'.

Key Changes

  • Amendment No. 1 to IS/ISO 11615:2017 has been established.
  • The amendment was established on July 18, 2024.
  • The standard without the amendment will remain in force until August 17, 2024.

Impact Analysis

Impact on Pharmaceutical Industry

  • IT systems and data structures related to medicinal product identification and exchange will need to be updated.

Impact on Healthcare Professionals

  • The amendment might improve data accuracy and interoperability within the healthcare system.

Impact on Regulatory Bodies

  • They might need to update their systems and processes to accommodate the changes.

Suggested Action Items

  • Consult with IT specialists and regulatory experts to ensure smooth transition.

Key Entities Referenced

Bureau of Indian Standards (BIS): The issuing authority of the notification, responsible for establishing and amending Indian Standards. Department of Consumer Affairs: The department under which BIS operates. IS/ISO 11615:2017: The Indian Standard that has been amended. It concerns health informatics and the identification of medicinal products. Amendment No. 1: The specific amendment to IS/ISO 11615:2017. Bureau of Indian Standards Rules, 2018: The rules under which the BIS operates and which provide the legal basis for this notification.
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रजिस्ट्री स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99 सी.जी.-डी.एल.-अ.-28072024-255823 xxxGIDHxxx CG-DL-E-28072024-255823 xxxGIDExxx असाधारण EXTRAORDINARY भाग III—खण् ड 4 PART III—Section 4 प्राजधकार स ेप्रकाजित PUBLISHED BY AUTHORITY स.ं 566] नई दिल्ली, िुक्रिार, िुलाई 26, 2024/श्रािण 4, 1946 No. 566] NEW DELHI, FRIDAY, JULY 26, 2024/SHRAVANA 4, 1946 भारतीय मानक ब्य रू ो (उपभोक्त ा मामल ेजिभाग) अजधसचू ना नई दिल्ली, 22 िुलाई, 2024 सिं भ:भ HQ-PUB015/1/2020-PUB-BIS (966).— भारतीय मानक ब्यूरो जनयम, 2018 के जनयम 15 के उपजनयम (1) के अनुसरण म ें भारतीय मानक ब्यूरो एतिद्वारा अजधसूजचत करता ह ै इसम ें संलग्न अनूसूची में दिय े गय े मानकों में संिोधन दकये गय ेह|ैं अनुसूची क्रम स्ट्थाजपत भारतीय मानकों की सख्ं या, िर् भ तथा संिोधनों की संिोधनों की जतजथ िब तक सं. िीर्भक संख्या एिं जतजथ प्रजतस्ट्थापन जतजथ मानक तीसरे स्ट्तंभ में इंजगत संिोधन के जबना भी लाग ूरहगे ा (1) (2) (3) (4) (5) 1 आई एस/आई एस ओ 11615 : 2017 संिोधन संख्या 1 18 िुलाई 2024 17 अगस्ट्त 2024 स्ट्िास्ट््य सूचना जिज्ञान — और्धीय उत्पािों की िुलाई 2024 4633 GI/2024 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART III—SEC.4] पहचान — और्धीय उत्पाि सचू ना की जिजिष्ट पहचान और आिान-प्रिान के जलए डेटा एजलमेंट्स और स्ट्रक्चसभ पी. रािेि, िैज्ञाजनक िी एिं उप महाजनिेिक (आई टी एस, पी आर टी एिं टी एन एम) [जिज्ञापन-III/4/असा./335/2024-25] BUREAU OF INDIAN STANDARDS (Department of Consumer Affairs) NOTIFICATION New Delhi, the 22nd July, 2024 Ref: HQ-PUB015/1/2020-PUB-BIS (966).— In pursuance of Sub-rule (1) of Rule (15) of the Bureau of Indian Standards Rules, 2018, the Bureau of Indian Standards hereby notifies that Amendments to Indian standards, particulars of which are given in schedule hereto annexed have been established. THE SCHEDULE Sl No., Year & Title of the Indian Standard No. and Date of Date till which No. Month/Year of the Establishment the standard Amendment of the without the Amendment amendment as mentioned in column 3 shall remain in force (1) (2) (3) (4) (5) 1 IS/ISO 11615 : 2017 Amendment No. 1 18 July 2024 17 August 2024 Health Informatics — Identification of July 2024 Medicinal Products — Data Elements and Structures for the Unique Identification and Exchange of Regulated Medicinal Product Information P. RAJESH, Scientist G & DDG (ITS, PRT & TNM) [ADVT.-III/4/Exty./335/2024-25] Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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