JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
vide information regarding the use of the product outside of Japan, including whether a marketing authorisation for the product has already been obtained outside of Japan. However, such infor- mation is one of the various factors to be con- sidered in the course of the MHLW’s marketing authorisation application examination process. The MHLW does not necessarily expedite the issuance of the marketing authorisation in Japan even if marketing authorisation for the product has already been obtained outside of Japan. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices Pharmaceutical Manufacturers A manufacturing business licence is required in order to manufacture pharmaceuticals in Japan. If a manufacturer of an imported product is located outside Japan, that manufacturer will be required to obtain accreditation as a foreign manufacturer. A manufacturing business licence is granted by the relevant prefectural govern- ment and such accreditation is granted by the MHLW. Once an application for a manufacturing business licence is formally submitted, the pre- fectural government reviews the application and – in most cases – conducts an on-site inspection of the applicant’s manufacturing premises. The period of validity of a manufacturing business licence and an accreditation is five years. Medical Device Manufacturers Unlike pharmaceutical manufacturers, a medical device manufacturer – whether located in Japan or outside Japan – is only required to satisfy a prior registration (ie, registration with the MHLW
as a medical device manufacturer). The registra- tion must be renewed every five years.
6. Distribution of Pharmaceuticals and Medical Devices 6.1 Wholesale of Pharmaceuticals and Medical Devices In order to market pharmaceuticals or medical devices, the initial marketing entity must hold a marketing business licence and have marketing authorisation for each of the relevant products. A marketing business licence is granted by the rel- evant prefectural government. Once an applica- tion for a marketing business licence is formally submitted, the prefectural government 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 dis- tributed by the applicant. Wholesalers and retail- ers of pharmaceuticals and medical devices are also required to obtain a distribution 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 marketing prescription pharmaceuticals. A Type 2 marketing business licence is required for marketing other pharmaceuticals (ie, non- prescription ethical pharmaceuticals and OTC pharmaceuticals).
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