WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/451
25 September 2000
(00-3835)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   JAPAN
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health and Welfare
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:           
3. Notified under Article 2.9.2 [     ], 2.10.1 [ X  ], 5.6.2 [    ], 5.7.1 [    ], other:           
4. Products covered (HS or CCCN where applicable, otherwise national tariff heading.
ICS numbers may be provided in addition, where applicable):   Pharmaceuticals
(HS 30.01, 30.02, 30.03, 30.04, 30.05, 30.06)
5. Title, number of pages and language(s) of the notified document:   Enforcement of
standards for labelling and product names of pharmaceuticals to prevent medication errors
6. Description of content:
1. Standard for the warning labelling on packages of pharmaceuticals whose shape or
appearance could lead to medication errors;
2. Standard for the labelling on packages of pharmaceuticals for the easy recognition
of the labelling;
3. Standard for product names of pharmaceu ticals to avoid confusion among different
product names and their abbreviations.
(These Standards are not mandatory but voluntary.)
7. Objective and rationale, including the na ture of urgent problems where applicable:
To prevent medication errors related to pharmaceuticals, considering the recent increase of
medication errors in Japan.
8. Relevant documents:   Pharmaceutical Affairs Law (Law No. 145 issued in 1960)
9. Proposed date of adoption:
Proposed date of entry into force: }Mid-September 2000
10. Final date for comments:           
11. Texts available from:  National enquiry point [  X ] or address, e-mail and telefax
number of the other body:
Safety Division, Pharmaceuticals and Medical Safety Bureau
Ministry of Health and Welfare
Kasumigaseki 1-2-2, Chiyoda-ku
Tokyo 100-8045
JapanTel.:  +81-3-3595-2453  Fax:  +81-3-3508-4364