Various blacklist systems are being implemented in a number of
areas of Chinese administration, and from 1 October 2012 there will
be a blacklist system in place for pharmaceutical security.
Pharmaceutical companies are advised to pay close attention to
this.
According to the trial version of the Provisions on the
Administration of a Drug Safety Blacklist ("Blacklist
Provisions") published by the State Food and Drug
Administration ("SFDA") on 13 August 2012, if any of the
following events occur, the entities and those individuals in the
pharmaceutical industry who are directly responsible will be added
to the blacklist by the SFDA and to the counterpart list at
provincial level:
1. Medicine approval certificates, medicine production licenses,
medicine trading licenses or pharmaceuticals permits for medical
institutes are revoked due to the manufacturing or distribution of
counterfeit drugs or sub-standard drugs;
2. Medical devices registration certificates, medical devices
manufacturing licenses or medical devices trading licenses are
revoked due to medical devices being manufactured without the
appropriate certificate, serious cases of national standards or
industry standards not being met and medical devices being
manufactured or delivered which do not meet legal requirements and
which result in serious consequences;
3. Concealing relevant information or providing false materials
during applications for relevant administrative licenses;
4. Obtaining relevant administrative licenses, certificates or
other qualifications by providing false documents and samples or by
other improper means, such as cheating or bribery;
5. Fabricating or intentionally destroying a site, destroying
relevant evidence, refusing or evading supervision and inspection,
refusing to provide relevant materials, unauthorised use of
articles that have been seized or distrained during the
investigation process;
6. Receiving a criminal penalty due to crimes relating to drugs and
medical devices;
7. Severe quality and security incidents occurring as a result of
any other illegal manufacturing or distribution of drugs and
medical devices or intentionally aggravated and unlawful acts
relating to drugs and medical devices which could cause serious
harm.
In addition to being blacklisted, the entities in situation three
above will be barred from applying for the relevant administrative
licenses for one year, and the entities in situation four will be
barred from applying for the administrative licenses for three
years in addition to a revocation of the licenses.
The blacklist information will be published on the official
websites of SFDA and its counterpart at the provincial level, in
general for two years from the date of the penalty. After
expiration of the two-year period, the blacklist information will
be moved to the blacklist database for public inquiry. This means
the blacklist history cannot be deleted once it is recorded.
It is not uncommon to see the above-listed situations, particularly
situations three and four, in practice. The consequence of such
blacklisting will undoubtedly be a detriment to life sciences
companies in the future; these companies are therefore advised to
scrutinise their business compliance to avoid being included on the
blacklist.
This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to www.law-now.com/law-now/mondaq
Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.
The original publication date for this article was 28/09/2012..
