. /.WORLD TRADE
ORGANIZATIONG/TBT/Notif.99/644
22 December 1999
(99-5528)
Committee on Technical Barriers to Trade
NOTIFICATION
The following notification is being circulated in accordance with Article 10.6.
1. Member to Agreement notifying:   CZECH REPUBLIC
If applicable, name of local government involved (Articles 3.2 and 7.2):           
2. Agency responsible:   Ministry of Health
Agency or authority designated to handle comments regarding the notification shall be
indicated if different from above:           
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):   Pharmaceuticals
(HS Chapter 30)
5. Title, number of pages and language(s) of the notified document:   Amendment to the
Act No. 79/1997 Coll., on Pharmaceuticals and Amendments to Some Related Acts
(in Czech)
6. Description of content:   Items related to the process of registration of medicinal products –
simplification of procedure, adoption of the EU time limit, possibility of recognition of
foreign expertise, classification of the product for general sale during registration process,
data exclusivity period of 6 years related to the first authorisation in the EU, notificationprocedure of 30 days for Type I variations, definition of Urgent Safety Restriction,
possibility of use of non-registered products (named patient use).
Items related to clinical trials – definitions of adverse drug reaction and events used
according to the International Conference on Harmonisation (ICH), more detailed principles
of good clinical practice.
Blood banks and collection centres in GMP regime and supervised by drug regulatory
authority.
Establishing of responsible person in a pharmacy.
7. Objective and rationale, including the na ture of urgent problems where applicable:
Implementations of further relevant parts of Acquis Communautaire, especially provisions
included in Directive 65/65/EEC, 89/381/EEC , 91/356/EEC, 92/26/ EEC and Regulations
541/95 and 542/95 as amended. Relevant orders decrees will describe these issues more in
details.
8. Relevant documents:   Act 79/1997 Coll.G/TBT/Notif.99/644
Page 2
9. Proposed date of adoption:
Proposed date of entry into force:  30 June 2000
10. Final date for comments:   28 February 2000
11. Texts available from:  National enquiry point [ X] or address, e-mail and telefax
number of the other body:           