Version 2.78

Part Description

LP248456-8   Blanket no changes certification of product listing
A blanket 'no changes' certification covers all listed drug products for which listing information has previously been submitted electronically and no listing information has changed since the previous update. [https://www.federalregister.gov/documents/2016/08/31/2016-20471/requirements-for-foreign-and-domestic-establishment-registration-and-listing-for-human-drugs#p-822] Source: Regenstrief LOINC

Fully-Specified Name

Component
Blanket no changes certification of product listing
Property
-
Time
-
System
^FDA package insert
Scale
Nar
Method

Additional Names

Short Name
FDA insert Blnkt no chngs cert prod list

Basic Attributes

Class
DOCUMENT.REGULATORY
Type
Clinical
First Released
Version 2.61
Last Updated
Version 2.61
Order vs. Observation
Both

Language Variants Get Info

Tag Language Translation
es-MX Spanish (Mexico) Certificación general sin cambios de la lista de productos:-:-:^ Prospecto de la FDA:Narrativo:
it-IT Italian (Italy) Certificazione generale senza cambiamenti di una lista di prodotti:-:-:^FDA, foglio illustrativo:Nar:
Synonyms: Documentazione normativa Foglio illustrativo della Food and Drug Administra
zh-CN Chinese (China) 关于产品列名的综合式无变更证书:-:-:^FDA 包装说明书:叙述型:
Synonyms: SPL;结构化产品标签;结构化产品标签;Structured Product Labelling;结构化产品标记;结构化产品标识;美国食品及药品管理局包装说明书;超系统 - FDA 包装说明书;食品及药品管理局包装说明书;FDA 包装插页 关于产品列名（产品提列、产品清单、产品列表）的综合式（总括式）无变更证书 叙述;叙述性文字;报告;报告型;文字叙述;文本叙述型;文本描述;文本描述型 监管类文档 认证（检定、证明、鉴定、发证、出具课程结业证书、确认）;医疗认证级别（等级、水平）;medical certification level

LOINC Terminology Service (API) using HL7® FHIR® Get Info

CodeSystem lookup
https://fhir.loinc.org/CodeSystem/$lookup?system=http://loinc.org&code=86445-4