RESTRICTED
WORLD TRADE G/TBT/Notif.96.17
6February 1996
ORGANIZATION
(96-0427)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: BELGIUM
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Ministry ofPublic Health, Pharmaceutical Inspectorate, CAE,
Quartier Vésale, 1010 Brussels
3. Notified under Article 2.9.2 [X],2.10.1 [],5.6.2 [],5.7.1 [],other:
4. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers maybeprovided inaddition, where applicable): Starting materials, i.e.all
substances orcompounds which arenotinthemselves medicinal products, purchased by
thedispensing chemist fordistribution assuchorafter undergoing processing, orfor
incorporation inanofficinal ormagistral preparation.
5. Title andnumber ofpages ofthenotified document: Draft Royal Decree onthe
Inspection andAnalysis ofStarting Materials Used byDispensing Chemists
6. Description ofcontent: Thedraft concerned laysdown theobligations ofdispensing
chemists withregard tocontrol. Thechemist maybereleased from thedutytoperform
analyses incertain cases, when heusesstarting materials obtained from anauthorized
supplier. Theaimofthesystem istointroduce anoptional system ofauthorizations.
7. Objective andrationale: Toencourage theuseofstarting materials ofsuitable quality
forthepreparation ofofficinal ormagistral preparations
8. Relevant documents: Opinion dated 11May1995 bytheCommission oftheEuropean
Communities (P12/1323/50.176) fortherepeal andreplacement oftheRoyal Decree
dated 20October 1994 concerning theinspection andanalysis ofstarting materials used
bydispensing chemists.
9. Proposed dateofadoption andentry intoforce: 60days
10. Final dateforcomments:
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: CIBELNOR