On June 25, 2007, TPD released a draft guidance document relating to the Data Protection Regulations which came into force last October. The draft guidance document speaks to, inter alia , the scope of data protection, requirements for marketing, the Register of Innovative Drugs, terms of protection, how the Minister will implement decisions with respect to providing data protection or not, and pediatric data protection.

Comments on the draft guidance are being sought by September 17, 2007.

To review the draft guidance document, please see:

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/data_donnees_protection_e.pdf