Fagg | search
Click here to view Fagg news from 60+ newspapers.
Bookmark or Share- Guidance on compassionate use and medical need programs. - AFMPSFAGG‐AFMPS Division R&D – unit “unmet medical need” Place V. Hortaplein 40,40 1060 Bruxelles/Brussel The famhp accepts either a submission of a paper dossier (in 5‐fold) or a submission of an electronic application which is highly recommended. If applicants choose the submission by electronic means, 2
- National FAQ on variations - AFMPShttp://www.fagg-afmps.be/nl/items-HOME/bijdragen/ Question 2.7: How do I need to submit a transfer of MAH? What type of variation do I need to submit? What are the fees for this type of variation? Answer: A transfer of MAH is an national, administrative variation, which follows the
- Inspection - Annual report 2023Directorate General Inspection competent for all inspection and control activities Industry Distribution Dispensing Authorisations Medical Devices Special Investigation Industry Division Inspections 120 good manufacturing practice inspections 46 good clinical practice inspections concerning medicines Rapid alert systeem 418 rapid alerts on the quality of medicines Analyses of products on the ...
- Annual report 2023 - FAMHPIn the spotlight Our results per service Directorate General PRE authorisation Directorate General POST authorisation Directorate General Inspection Transversal support Give your opinion about our annual report The FAMHP is constantly striving to improve and we therefore need your feedback. Please give our annual report a score for content and design. Give your opinion
- Processes for Performance IVDR in Belgium - fagg-afmps.bewww.fagg.be - www.afmps.be Directorate-General PRE authorisation Research and Development Division (human use) The Federal Agency for Medicines and Health Products (FAMHP) is the Belgian competent authority responsible for the quality, safety and efficacy of medicines and health products in clinical development and on the market.
More
