(Yicai Global) Nov. 12 -- China's State Administration for Market Regulation published a draft law on vaccine management on its website yesterday, seeking feedback from the public.
The legislation would raise vaccines to the level of national security and impose a fine of 10 times the value of any 'problematic' products on companies or individuals who violate the law, the strictest punishment ever imposed for such offenses.
Article 89 states that holders of vaccine marketing licenses would be deprived of their illegal income, forced to suspend production and be fined five to 10 times the value of the vaccines involved. Those who flout the rules could also have their permits cancelled and face fines of between CNY1 million (USD143,540) and CNY5 million if the value of the vaccines is less than CNY500,000.
The legal representative, principal responsible person and key personnel at offending companies face having their illegal gains confiscated and a fine equivalent to the whole or half of that income. They would also be banned from pharmaceutical production and related business activities for 10 years.
Under the draft law, illegal acts include submitting false clinical trials and permit application materials; fabricating production records and changing product batch numbers; submitting false approval materials and adopting other deceptive means to obtain certification; and not recalling problem vaccines.