The Ministry of Health, Labour and
Welfare Ministerial Notification No. 65
Pursuant to Paragraph 1, Article 41 of the Pharmaceutical Affairs Law (Law No.
145, 1960), the Japanese Pharmacopoeia (hereinafter referred to as ``new Phar-
macopoeia''), which has been established as follows*, shall be applied on April 1,
2011. However, in the case of drugs which are listed in the Pharmacopoeia (herein-
after referred to as ``previous Pharmacopoeia'') [limited to those listed in the
Japanese Pharmacopoeia whose standards are changed in accordance with this
notification (hereinafter referred to as ``new Pharmacopoeia'')] and drugs which
have been approved as of April 1, 2011 as prescribed under Paragraph 1, Article 14 of
the same law [including drugs the Minister of Health, Labour and Welfare specifies
(the Ministry of Health and Welfare Ministerial Notification No. 104, 1994) as those
exempted from marketing approval pursuant to Paragraph 1, Article 14 of the
Pharmaceutical Affairs Law (hereinafter referred to as ``drugs exempted from
approval'')], the Name and Standards established in the previous Pharmacopoeia
(limited to part of the Name and Standards for the drugs concerned) may be accepted
to conform to the Name and Standards established in the new Pharmacopoeia before
and on September 30, 2012. In the case of drugs which are listed in the new Phar-
macopoeia (excluding those listed in the previous Pharmacopoeia) and drugs which
have been approved as of April 1, 2011 as prescribed under Paragraph 1, Article 14 of
the same law (including those exempted from approval), they may be accepted as
those being not listed in the new Pharmacopoeia before and on September 30, 2012.
Ritsuo Hosokawa
The Minister of Health, Labour andWelfare
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