MOHW imposes 'CSO Reporting & Training' duty to copromoters
By Lee, Jeong-Hwan | translator Kang, Shin-Kook
24.07.19 06:30:04
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CSO representatives and MRs must complete 24 hours of new training before reporting to local governments
15-day business suspension imposed when first caught using untrained employees
False reports, closure of sales offices... if the company does not report changes, 1st offense – 3-day business suspension; 4thoffense – 1-month business suspension
The government announced on the 18th an amendment to the Enforcement Rules of the Pharmaceutical Affairs Act that imposes the same level of local government reporting and employee training obligations on pharmaceutical companies that have signed co-promotion agreements with drug companies that have obtained the official marketing authorization.
Initially, the government considered adjusting the reporting and training obligations for co-marketing pharmaceutical companies to a reasonable level in the amendment to the Enforcement Rules, but ultimately decided it would be difficult to exempt co-marketing pharmaceutical companies from the CSO reporting and education obligations in a subordinate law
Lee, Jeong-Hwan(junghwanss@dailypharm.com)
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