CHINA Law and Practice Contributed by: Alan Zhou, Coco Fan, Kelly Cao and Stephanie Wang, Global Law Office
7.2 Importer of Record of Pharmaceuticals and Medical Devices An importer of record of pharmaceuticals and medical devices is required to conduct a filing with China Customs as the customs declaration enterprise (either as a customs broker or as a consignee of imported/exported goods). If the importer of record concurrently acts as the applicant for the NMPA’s import filing (see 7.3 Prior Authorisations for the Import of Phar- maceuticals and Medical Devices ) and port inspection for imported pharmaceuticals, it must maintain a drug distribution licence or a drug manufacturing licence (for active pharmaceutical ingredients and intermediate agents). 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices Prior Authorisations for Importation of Pharmaceuticals The following require prior authorisation: • in general, imported pharmaceuticals must obtain marketing authorisations from the NMPA prior to importation. An additional import permit issued by the NMPA is required for narcotic drugs and psychotropic drugs; • in exceptional cases, pharmaceuticals can be imported by means of a special approval from the NMPA; • a small number of drugs to be imported by a hospital and used for specific medical pur- poses due to urgent clinical needs; • drug samples for drug registration purposes; and • comparator drugs (except narcotic drugs and psychotropic drugs) for the purposes of drug registration or consistency evaluation of generic drugs.
Individuals bringing drugs to China for their personal use are exempted from these require- ments. Prior Authorisations for Importation of Medical Devices The following applies: • imported medical devices will first be filed/ registered with the NMPA and obtain market- ing authorisations; • if the imported medical devices fall into the Catalogue of Products Subject to the Com- pulsory Product Certification System, a Chi- nese compulsory certification is required; • if the imported medical devices fall into the Catalogue of Commodities Subject to the Automatic Import Licence Administration, an automatic import licence is required; and • if medical devices are imported for emer- gency use, an approval from expert evalua- tion organised by the CMDE of the NMPA is required. To meet peoples’ needs for pharmaceuticals and medical devices, more and more policies have been issued by local governments to optimise import approval procedures for designated med- ical institutions to apply for drugs and medical devices in urgent clinical needs, such as nine cities in the Guangdong Province-Hong Kong- Macao Greater Bay Area, Beijing and Hainan Boao Lecheng International Medical Tourism Pilot Zone. A tax exemption is also applicable. 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports The importation of drugs or medical devices is subject to registrations/permits, compulsory national or industrial standards and specific reg- ulations. To guarantee the public’s safe use of pharmaceuticals and medical devices, the laws
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