RESTRICTED
WORLD TRADE G/SPS/N/BEL/3
31May1995
ORGANIZATION
(95-1451)
Committee onSanitary andPhytosanitary Measures
NOTIFICATION
1. Member toAgreement notifying: BELGIUM
Ifapplicable, name oflocal government involved:
2. Agency responsible: Ministry ofSocial Affairs, Public Health andtheEnvironment
Inspectorate General ofPharmaceutical Matters
CitéAdministrative del'Etat
Quartier Vésale
B-1010 Brussels
3. Products covered (HSorCCCN where applicable, otherwise national tariff heading.
ICSnumbers may beprovided inaddition, where applicable):
-Medicinal premixtures: anyveterinary medicament prepared inadvance withaview
tothesubsequent preparation ofmedicated feedingstuffs.
-Medicated feedingstuffs: anymixture ofveterinary medicament(s) andfeedingstuffs
prepared prior tobeing placed onthemarket andintended foradministration to
animals without processing onaccount ofthecurative, preventive orother properties
ofthemedicament.
4. Title andnumber ofpages ofthenotified document: Royal Order Concerning Medicinal
Premixtures andMedicated Feedingstuffs forAnimals
5. Description ofcontent: Thepurpose ofthisdraft istoestablish theconditions forthe
registration ofmedicinal premixtures forthepurpose ofobtaining theauthorization to
manufacture, divide intodoses, package, import, export andengage inthewholesale
trade ofmedicinal premixtures aswellastheconditions forobtaining theauthorization
tomanufacture medicated feedingstuffs.
./.G/SPS/N/BEL/3
Page2
6. Objective andrationale: Transposition ofthefollowing directives:
-Council Directive 81/851/EEC of28September 1981 ontheapproximation ofthe
legislative provisions ofmember States relating toveterinary medicaments.
-Council Directive 81/852/EEC of28September 1981 ontheapproximation ofthe
laws ofmember States concerning analytical, toxico-pharmacological andclinical
standards andprotocols relating tothetesting ofveterinary medicaments.
-Council Directive 90/167/EEC of26March 1990 establishing theconditions forthe
preparation, placing onthemarket anduseofmedicated feedingstuffs inthe
Community.
7. Aninternational standard, guideline orrecommendation does notexist [].
Ifaninternational standard, guideline orrecommendation exists, whenever possible,
identify deviations:
8. Relevant documents:
-Lawof21June1983 onmedicated feedingstuffs.
-Repealed bydraft royal orders of12June1984, establishing theactive substances
thatmaybeincorporated intomedicinal premixtures, and26February 1985, on
medicinal premixtures andmedicated feedingstuffs.
-Directives 81/851/EEC, 81/852/EEC and90/167/EEC.
9. Proposed date ofadoption andentry intoforce: 60days
10. Final date forcomments:
11. Texts available from: National enquiry point []oraddress andtelefax number ofother
body: CIBELNOR