MHRA Guidance – Nitrosamines Impurities in Medicines MHRA Guidance – Nitrosamines Impurities in Medicines MHRA has published guidance to help medicine manufacturers meet safe limits on levels... MHRA Guidance – Nitrosamines Impurities in Medicines
PAGB Reclassification Workshop PAGB Reclassification Workshop Reclassification is a vital part of PAGB’s work and we are pleased to be running our very... PAGB Reclassification Workshop
EMA – IRIS Platform Transition and Webinar EMA – IRIS Platform Transition and Webinar EMA is working on the transition of regulatory procedures for Product Lifecycle Management... EMA – IRIS Platform Transition and Webinar
MHRA Publishes Marketing Authorisations Granted 1 August to 14 August 2023 MHRA Marketing Authorisations Granted 1 August to 14 August 2023 MHRA granted three OTC licences during 1 – 14 August... MHRA Publishes Marketing Authorisations Granted 1 August to 14 August 2023
MHRA Publishes Marketing Authorisations Granted for July 2023 MHRA Publishes Marketing Authorisations Granted for July 2023 The Medicines and Healthcare products Regulatory Agency (MHRA) granted two OTC licences... MHRA Publishes Marketing Authorisations Granted for July 2023
MHRA Updates Guidance on Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing MHRA Updates Guidance on Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing MHRA has updated its guidance ‘Medicines:... MHRA Updates Guidance on Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
EMA HMPC Meeting Report – July 2023 EMA HMPC Meeting Report – July 2023 EMA’s Committee on Herbal Medicinal Products (HMPC) has published the report from their... EMA HMPC Meeting Report – July 2023
EMA HMPC Launches Call for Data on Maydis Stigma (Zea mays L.) EMA HMPC Launches Call for Data on Maydis Stigma (Zea mays L.) The European Medicines Agency’s (EMA) Committee on Herbal... EMA HMPC Launches Call for Data on Maydis Stigma (Zea mays L.)
Updated EMA Q&A on Consultation Procedure to EMA by Notified Bodies on Ancillary Medicinal Substance / Ancillary Human Blood Derivative Incorporated in a Medical Device Updated EMA Q&A on Consultation Procedure to EMA by Notified Bodies on Ancillary Medicinal Substance / Ancillary Human Blood Derivative... Updated EMA Q&A on Consultation Procedure to EMA by Notified Bodies on Ancillary Medicinal Substance / Ancillary Human Blood Derivative Incorporated in a Medical Device
CMDh July 2023 Meeting – Report CMDh July 2023 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published... CMDh July 2023 Meeting – Report
MHRA Renewing Marketing Authorisations for Medicines – Guidance Updated MHRA Renewing Marketing Authorisations for Medicines – Guidance Updated MHRA has updated their guidance on renewal applications to... MHRA Renewing Marketing Authorisations for Medicines – Guidance Updated
Nitrosamines – Revised Q&A for Marketing Authorisation Holders/Applicants Nitrosamines – Revised Q&A for Marketing Authorisation Holders/Applicants The revised EMA/HMA Questions and answers for marketing authorisation holders/applicants on the... Nitrosamines – Revised Q&A for Marketing Authorisation Holders/Applicants