Marketing Authorisation for Human Medicines in Latin America
Termindetails
Wann
von 10:00 bis 18:00
Wo
Kontakttelefon
Teilnehmer
The seminar will focus on human medicinal products (chemicals and biologics; herbals will not be addressed).
Brazil, Mexico, Argentina, Chile, Peru, Colombia, Venezuela etc are lucrative countries for marketing pharmaceuticals. The essential precondition is of course a national marketing authorisation.
What are the local requirements for these marketing authorisations? Which data, concepts etc can be used from a European point of view? These are the key questions to be answered during this seminar.
May we invite you for a thorough discussion with two experts on
- dossier requirements
- marketing authorisation procedures, and
- maintenance duties?
You are welcome to join this meeting for a successful entry on the Latin American market.
Topics:
- Legal framework and national authorities
- National marketing authorisation procedures
- Dossier requirements - NCEs and generics
- Maintenance of the marketing authorisation
- National specialities in Brazil, Mexico, Argentina, Chile, Peru, Colombia and Venezuela
