A new version 2.8 of the eCTD/NeeS validation tool from the Belgium Federal Agency for Medicines and Health Products (FAHMP) is available for download from the e-Submission...[more]
The Belgium Federal Agency for Medicines and Health Products released today an explanatory document regarding automatic e-mails send by the agency during the evaluation of...[more]
The Spanish drug regulatory agency AEMPS released a new version 1.15 of their national Spanish NeeS guidance. The updated guidance is available in Spanish languange only from...[more]
The Austrian drug regulatory agency AGES PharmMed announced today that from now on electronic-only submissions for medicinal products for human use will...[more]
The Bulgarian Drug Agency (BDA) announced that starting from January 2010, electronic submissions for medicinal products for human use are mandatory for national and European...[more]
The Irish Medicines Board (IMB) released a short guidance document titled "GUIDE TO ELECTRONIC SUBMISSIONS – VETERINARY MEDICINES" in which the requirements for...[more]
The French drug regulatory agency, Afssaps, has released a new version of their "Notice to Applicants for Marketing Authorisations for Medicinal Products for Human Use"....[more]
