000 02352cam  2200397zi 4500
0019.927743
003CaOODSP
00520231130151040
006m     o  d f      
007cr mn|||||||||
008230925e202311  onc     o    f000 0 eng d
020 |a9780660680651
040 |aCaOODSP|beng|erda|cCaOODSP
043 |an-cn---
0861 |aH164-305/2023E-1-PDF
24500|aGuidance document : |bcertificates of supplementary protection.
24617|aCSP guidance document
264 1|aOttawa, ON : |bHealth Canada = Santé Canada, |cNovember 2023.
264 4|c©2023
300 |a1 online resource (25 pages)
336 |atext|btxt|2rdacontent
337 |acomputer|bc|2rdamedia
338 |aonline resource|bcr|2rdacarrier
500 |aIssued also in French under title: Ligne directrice : certificats de protection supplémentaire.
500 |aCover title.
500 |a"Date adopted: 2017/09/21; Revised Date: 22023/11/16; Effective date: 2023/11/16."
520 |a"In agreeing to apply the Canada-European Union Comprehensive Economic and Trade Agreement (CETA), Canada has committed to provide up to two years of sui generis (of its own kind) protection for new pharmaceutical products protected by an eligible patent, from the expiry of the patent. Canada has implemented this commitment by introducing Certificates of Supplementary Protection (CSPs) for medicinal ingredients, applicable for Canadian pharmaceuticals, biologics and veterinary drugs. … The purpose of this Guidance Document is to outline the CSP application process for applicants, the service standard and the roles and responsibilities of applicants and Health Canada"--Introduction, page 7.
650 0|aPatent medicines|zCanada.
650 0|aPatent extensions|zCanada.
650 0|aPharmaceutical policy|zCanada.
7101 |aCanada. |bHealth Canada, |eissuing body.
77508|tLigne directrice : |w(CaOODSP)9.927744
795 |tGuidance document : |w(CaOODSP)9.921627
85640|qPDF|s467 KB|uhttps://publications.gc.ca/collections/collection_2023/sc-hc/H164-305-2023-1-eng.pdf
8564 |qHTML|sN/A|uhttps://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/register-certificates/certificate-supplementary-protection-regulations.html