. /.WORLD TRADE
ORGANIZATIONG/TBT/Notif.00/146
23 March 2000
(00-1211)
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
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:   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):   Medical products for
human use
5. Title, number of pages and language(s) of the notified document:   Draft Regulations on
Registration of Medical Products (on issuing Marketing Authorisations) (61 pages, available
in Latvian)
6. Description of content:  Description of content: Requirements on registration of medical
products (issuing authorization to place medical products on the market), suspension and
revoking of authorization to market medical products, including additional provisions for
radio-pharmaceuticals, immunological medical products consisting of vaccines, toxins orserums and allergens, homeopathic medical products and medical products from human
blood or human plasma, duties of the experts, examination of the application for
authorization to place medical products on the market, rules to tests, the compilation of
dossiers and the examination of application, variations to the registration dossier, colouring
materials which may be added to medical products, principle of recognizing decision of
other Member State.
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 efficiency of medical products. Law on Pharmaceutical activities and
Regulations on Cabinet of Ministers No 24 of 20 January 1998 include general requirements
on registration of medical products (issuing marketing authorizations) not fully
implementing Directive 65/65/EEC, amendments and implementing measures.
8. Relevant documents:   Council Directives 65/6 5/EEC; 66/454/EEC; 75/318/EEC;
75/319/EEC; 83/570/EEC; 87 /19/EEC; 87/21/EEC; 89 /341/EEC; 89/342/EEC;
89/343/EEC; 89/381/EEC; 91/ 507/EEC 92/27/EEC; 93/39/EEC; 93/73/EEC and Council
Regulations 2309/93/EC; 541/9 5/EC; 1146/98/EC; 78/25/EEC.G/TBT/Notif.00/146
Page 2
9. Proposed date of adoption:  1 May 2000
Proposed date of entry into force:  10 May 2000
10. Final date for comments:   30 March 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:
Ministry of Welfare
Department of Pharmacy
28 Skolas street
Riga, LV 1519Latvia
Tel: +371 7021608
Fax: +371 7021691
E-mail: Inguna_Maca@lm.gov.lv