Pharmaceutical Administration and Regulations in Japan - Nihs

devices, appointment of managers,
submission of notifications on selling
and leasing businesses of controlled
medical devices, license for repairing
medical devices, etc.)
Chapter 6: Standards and government
certification for drugs (Article 41 -
Article 43) (Japanese
Pharmacopoeia and other standards,
etc.)
Chapter 7: Handling of drugs
Section 1 Handling of Poisonous and
Deleterious Substances, (Article 44 -
Article 48) (Labeling, restrictions on
selling unsealed products, transfer
procedures, restrictions on supply,
storage and exhibition)
Section 2 Handling of Drugs (Article
49 - Article 58) (Selling of prescription
drugs, items included on immediate
containers and in package inserts,
prohibited entries, prohibition of
manufacturing, giving and marketing
of drugs, etc.)
Section 3 Handling of Quasi-drugs
(Article 59 - Article 60) (Items
included on immediate container,
etc.)
Section 4 Handling of Cosmetics
(Article 61 - Article 62) (Items
included on immediate container,
etc.)
Pharmaceutical Regulations in Japan:
Section 5 Handling of Medical
Devices (Article 63 - Article 65)
(Items included on immediate
container, etc., prohibition of selling
and manufacture)
Chapter 8: Advertising of drugs (Article
68-2 - Article 68-11) (False
advertising, restrictions on
advertising of drugs for designated
diseases, prohibition of advertising of
drugs before approval, etc.)
Chapter 8-2: Exceptions for biological
products (Article 69 - Article 77)
(Manufacturing supervisors, items
included on immediate containers,
package inserts, etc., prohibition of
selling and manufacture, explanation
of specified biological products by
appointed health professionals,
regular reports on infectious diseases,
preparation and retention of records
on biological products, guidance and
advice, complication and examination
of information on regular reports on
infectious diseases by the PMDA).
Chapter 9: Supervision (Article 69 - Article
76-3) (On-site inspections, on-site
inspections by the PMDA, emergency
orders, disposal, test orders, orders
for improvement, orders for
replacement of marketing
supervisors-general, supervision of
household distributors, cancellations
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