JAPAN Law and Practice Contributed by: Kenji Utsumi and Kensuke Suzuki, Nagashima Ohno & Tsunematsu
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations The Pharmaceuticals Law provides for an exceptional procedure to allow the importation of a pharmaceutical or medical device that has received foreign marketing authorisation for compassionate use if: • the foreign marketing authorisation was obtained in a country with a marketing authorisation system equivalent to the system in Japan; • immediate use of the pharmaceutical or medical device is necessary to prevent a pan- demic that could cause death or serious harm to the health of Japanese citizens; and • the pharmaceutical or medical device is spe- cifically designated under an administrative order. This special procedure was once used to import an influenza vaccine produced by a foreign man- ufacturer. It is also used for vaccines and thera- peutic drugs for COVID-19 that are produced by foreign manufacturers and supplied for use in Japan. 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations After the marketing of a pharmaceutical or a medical device commences, the marketing authorisation-holder is required to conduct post- marketing pharmacovigilance and technovigi- lance. If any issue relating to the effectiveness or safety of the marketed pharmaceutical or medical device is discovered during the post- marketing authorisation surveillance period, the marketer must conduct a pharmaceutical or medical device recall campaign, report the discovery to the PMDA, issue public notices,
Required information A marketing authorisation application must include, as an attachment, data concerning the results of clinical trials and other pertinent data – except where the application is for a medicine that is subject to a conditional early approval for market authorisation (an expedited process). Variation of a marketing authorisation Variation of a marketing authorisation – such as a change in the therapeutic indication, formula- tion, dosage, patient population, packaging or labelling – requires the marketing authorisation- holder to complete a formal process. Depending on the materiality of the change, the variation may require approval from the relevant authority or the mere submission of a report. Transferral of a marketing authorisation It is permissible for market authorisation to be transferred from the current marketing author- isation-holder to a transferee. A transferee of a marketing authorisation must notify the relevant authority of the transfer, evidenced by provid- ing the application for transfer addressed to the MHLW, at least one month prior to the date of transfer. The transferee must attach a document evidencing the transfer of the marketing authori- sation from the transferor (eg, a short-form sale and purchase agreement) and a supply agree- ment with a foreign manufacturer if the product is imported from the foreign manufacturer. The transferee must, in addition to obtaining mar- keting authorisation, obtain a business licence to market the pharmaceuticals. In the case of a transfer of the marketing business of a phar- maceutical product, the business transferee is required to apply for the marketing business licence well in advance so that it is issued on or before the effective date of the business transfer.
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