Pharmaceutical Administration and Regulations in Japan - Nihs

application.
- The marketer, etc. who acts as the
agent for the application files the
application after confirming from the
applicant the type of corporation of
the applicant, name, address, and
agent. The contact information for
the agent, and whether the agent is
a marketing authorization holder or a
manufacturer is entered in the
Remarks section of the application
form.
(2) Timing of applications for accreditation
of overseas manufacturers
The application should be submitted by
the time of the marketing approval
application. When accreditation is not
obtained beforehand, “under
application” should be entered in the
marketing approval application form
(Marketing approval can not be
obtained without accreditation
approval).
(3) Outline of the structure and facilities of
the manufacturing plant required for
accreditation of overseas
manufacturers and attached
documentation
- The outline of the structure and
facilities of the manufacturing plant
should be based on that in the
manufacturing business license
application in Japan. A list of the
Pharmaceutical Regulations in Japan:
structures and facilities must be
included.
- When Japanese can not be used as
the language in the attached
documentation under special
circumstances, a foreign language
can be used, but a Japanese
translation must be attached in such
cases. If the foreign language is
not English, certification of the
translator must be attached.
- A medical certificate from a
physician must be submitted when
the applicant is a corporation of the
executives involved in the business,
namely the executive with
representative authority and
executives involved in the business
without representative authority, and
a table showing the duties of the
executives must be attached.
When it is difficult to submit medical
certificates for physicians for
unavoidable reasons in countries
where the overseas manufacturer
has received authorization, it is
possible to submit documents
verifying that the executives involved
do not correspond to the provisions
of Article 5, Item 3(d) (excluding the
part related to adult wards) and (e) in
place of the medical certificates for
physicians.
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