Supplement your selection of national reference documents with our national summaries.
Tarius national expert summaries are original documents written by Tarius consultants, providing updated information about the practical implementation of the international regulations, guidelines and “best practices” in a particular country. The summaries cover all major aspects of the drug product life cycle from product development to the post-marketing period.

Country by country, following the same table of contents and answering the same set of questions, Tarius national summaries give a general overview of the national procedures and requirements related to essential issues such as clinical trials, the marketing authorization application, pricing and reimbursement and more. Specific details such as contact persons, fees, and labeling requirements are also described.

Topics described in our expert summaries

• National Authorities
  • Ministry for Health Products
  • National Health Product Authorities
  • Other National Authorities
• Drug Development
  • Scientific Advice
  • Conduct of Clinical Trials
• Marketing Authorisation Applications
  • The National Procedure
  • Electronic Submissions
  • Products Requiring Marketing Authorisations
  • Orphan Drug Designation
  • Format and Content of Applications
  • Packaging and Labelling Requirements
• Exemptions
  • Parallel Import
  • Compassionate Use / Temporary Use
• Import of Products Manufactured in Foreign Countries
  • Import of Health Products
• Maintenance of Marketing Authorisations
  • Variations
  • Renewals
  • Line Extensions
  • Transfers
  • Withdrawals
  • OTC Switch (Changes of Legal Status)
• Pricing and Reimbursement
• The Post Marketing Period
  • Adverse Event Reporting
  • Advertising
  • Inspection of Manufacturing Sites
  • Sale to Consumers
• National Fees
• National Industry Associations

Countries and regions described in our expert summaries:

• North America: Canada
• Latin America: Argentina, Brazil, Chile, Colombia, Ecuador, Mexico, Peru, Venezuela 
• Western Europe: Austria, Belgium, Cyprus, Denmark, European Union, Finland, France, Germany, Greece, Ireland, Italy, Portugal, Spain, Sweden, Switzerland, The Netherlands, United Kingdom
• Central and Eastern Europe: Bulgaria, Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovak Republic, Slovenia, Ukraine 
• Middle East: Israel
• Asia and the Pacific: ASEAN, Australia, China, Hong Kong, India, Japan, Malaysia, Singapore, South Korea, Taiwan, Thailand
• Africa: South Africa

Reviewed and updated monthly
Tarius' network of independent consultants review the summaries on a routine basis every month and update according to new legislation or changes of administrative procedures in their country.

Contact us to learn more about our expert summaries.