JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
each of the relevant products. A marketing business licence is granted by the relevant prefectural govern- ment. Once an application for a marketing business licence is formally submitted, the prefectural govern- ment reviews the application and – in most cases – conducts an on-site inspection of the applicant’s office or factory. Marketing business licences are generally valid for five years; however, the actual validity period will depend on – among other things – the type of pharmaceutical or medical device to be distributed by the applicant. Wholesalers and retailers of pharmaceuticals and medical devices are also required to obtain a distri- bution business licence. 6.2 Different Classifications Applicable to Pharmaceuticals There are two types of marketing business licences for pharmaceuticals: Type 1 and Type 2. A Type 1 marketing business licence is required for market- ing prescription pharmaceuticals. A Type 2 marketing business licence is required for marketing other phar- maceuticals (ie, non-prescription ethical pharmaceu- ticals and OTC pharmaceuticals). There are three types of marketing business licences for medical devices: • a Type 1 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class III or IV; • a Type 2 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class II; and • a Type 3 medical device marketing business licence is required for marketing medical devices with a GHTF classification of class I. 7. Import and Export of Pharmaceuticals and Medical Devices 7.1 Governing Law and Relevant Enforcement Bodies The Pharmaceuticals Law governs the import and export of pharmaceuticals and medical devices. Imports of pharmaceuticals and medical devices from
outside Japan are, in principle, subject to the same marketing regulations applicable to products manu- factured in Japan. Importers of these products are subject to requirements regarding marketing authori- sation, marketing business licences and accreditation as a foreign manufacturer. A manufacturing business licence is required for the manufacture of pharmaceuticals or medical devices that are to be exported from Japan. Although market- ing authorisation is not necessary, a separate regis- tration for manufacturing pharmaceuticals or medical devices for export is required. The relevant prefectural government regulates mar- keting business licences, whereas the MHLW regu- lates accreditations for foreign manufacturers. 7.2 Importer of Record of Pharmaceuticals and Medical Devices In principle, an importer of pharmaceuticals or medi- cal devices must obtain a marketing business licence, and is required to present certificates of the market- ing business licence and the marketing authorisation for each particular imported product to the relevant customs house. The Pharmaceuticals Law provides for exceptions to these requirements, such as where an individual imports small amounts of these products for their personal use. 7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices In principle, import of pharmaceuticals or medical devices is not permitted unless the importer on record possesses a marketing business licence and a mar- keting authorisation for each particular imported prod- uct. The Pharmaceuticals Law provides for exceptions to these requirements, such as where small amounts of these products are imported by an individual for their personal use. As regards permitted exceptions in the case of emergency situations, see 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations . 7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports In addition to obtaining a marketing business licence and marketing authorisation when importing pharma-
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