International Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง How to use the procedure for medicines licensing applications. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Send and receive information on adverse drug reactions (ADRs) From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 9, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
GeGant From European Medicines Agency (EMA) ๐ช๐บ Information about marketing authorisation application of GeGant, a device to obtain a solution containing radioactive gallium. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Operational Information Sharing From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on January 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
ZL404_00_001e_WL Guidance documentTransfer of marketing authorisation From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Guidance document on transferring marketing authorisation. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on May 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
How to draft a direct healthcare professional communication From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs) Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on April 4, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Requirements for Medical Devices Marketing Authorization (MDS-REQ 1) From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Regulation outlining the requirements for marketing authorization of medical devices. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated on December 19, 2021 Other (Public Domain) 0 reuses 0 favorites
Medical Device De Novo Classification Process From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2021-21677. The Food and Drug Administration (FDA) is issuing a final rule to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This final rule establishes procedures and criteria related toโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 5, 2021 Other (Public Domain) 0 reuses 0 favorites
Regulations Regarding โIntended Usesโ From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2021-15980. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its medical product "intended use" regulations. This final rule amends FDA's regulations describing the types of evidence relevant to determining whether a product is intended forโฆ Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 2, 2021 Other (Public Domain) 0 reuses 0 favorites
Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) From European Commission ๐ช๐บ Document provides guidance for applicants, marketing authorization holders, and notified bodies on implementing EU Medical Devices Regulations (2017/745 and 2017/746). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 15, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Brexit /consequences for operators From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Brexit reference document /consequences for the operators in your application process Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on May 25, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Comparator products in Bioequivalence/Therapeutic Equivalence studies From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on December 31, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Decree No. 2-14-841 on marketing authorization for medicinal products for human use From Ministry of Health and Social Protection (MSPS) ๐ฒ๐ฆ A legal document, Decree No. 2-14-841, outlines regulations for marketing authorization of medicinal products for human use. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on April 24, 2024 Other (Public Domain) 0 reuses 0 favorites