THIS WEBSITE IS ON SALE!!
This repository of information on pharma regulatory affairs in Latin America could be yours. GET THE READER FLOW YOU NEED TO PROMOTE YOUR PHARMA CONSULTING BUSINESS!! 1,500 VISITORS A MONTH AND GROWING. GET IN TOUCH! inesitag@hotmail.com / maria@latampharmara.com-
Our friends:
Index
- Regulatory Affairs in Emerging Markets
- Fundamentals of Regulatory Affairs
- Argentina
- Colombia
- Mexico
- Central America
- Interesting
- Blog
- Get in touch!
Tag Archives: new Disposition
Argentina: Site Master File now required by ANMAT for national sites
Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading
Posted in Argentina, Uncategorized
Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, drug products, electronic submission, GMP, Good Manufacturing Practices, inspections, Latin America, National Regulatory Agency of Regional Reference, new Disposition, regulatory affairs, Site Master File, SMF
2 Comments
Argentina: checklist for GMP inspections of API facilities
On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports … Continue reading
Posted in Argentina, Uncategorized
Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, GMP, ICH guidelines, new Disposition
Leave a comment
Regulatory Affairs in Latin America 