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National Expert Summaries – Human Drugs & Biologics

Tarius national expert summaries are original documents written by Tarius' national experts, 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 expert summaries give a general overview of the national procedures and requirements related to essential issues such as:

national procedures for scientific advice, clinical trials, submissions, fees, orphan drug designation, packaging & labeling requirements, pricing & reimbursement, maintenance of marketing authorisations, pharmacovigilance reporting and risk management, import and export, advertising, sale to consumers, and more.

In total, Tarius offers more than 30 national expert summaries per country.

All expert summaries include a reference section with direct links to the source documents from the national authorities. The national expert summaries are reviewed every month.

Contact us to learn more about our expert summaries.

 

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