. /.WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/445
25 September 2000
(00-3826)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   THE REPUBLIC OF LATVIA
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Welfare, Department of Pharmacy
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:   State Pharmaceutical inspection, State Agency of
Medicines
3. Notified under Article 2.9.2 [ X], 2.10.1 [    ], 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):   Medicinal products for
human use
5. Title, number of pages and language(s) of the notified document:   Draft Regulations on
Import, Export and Distribution of Medicinal Products (on issuing marketing
authorizations)  (31 pages, available in Latvian)
6. Description of content:   Requirements on import, export and distribution of medicinal
products, including requirements for import and export – licences and permissions,requirements for parallel import of medicinal products, testing of medicinal products,
requirements for wholesale trade (licences), including good distribution practice
requirements, recall procedures, including classification of product defects.
7. Objective and rationale, including the na ture of urgent problems where applicable:
To safeguard public health, consumer protection to provide and ensure improved quality,
greater safety and efficacy of medicinal products.  Law on Pharmaceutical activities defines
general principles and delegates Cabinet of Ministers to issue detailed regulations.
8. Relevant documents:   75/319/EEC;  89/341/EEC;  93/39/EEC;  91/356/EEC;  92/25/EEC;
89/342/EEC;  89/381/EEC
9. Proposed date of adoption:
Proposed date of entry into force: }IV quarter 2000
10. Final date for comments:   22 September 2000G/TBT/Notif.00/445
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11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:
Ministry of Welfare
Department of Pharmacy28 Skolas Street
Riga
Latvia, LV 1331
Tel: +371 7021608
Fax: +371 7021691
Email: Juris_Bundulis@lm.gov.lv, Inguna_Maca@lm.gov.lv