WORLD TRADE G/TBT/Notif.97.245
16June1997
ORGANIZATION
(97-2451)
Committee onTechnical Barriers toTrade
NOTIFICATION
Thefollowing notification isbeing circulated inaccordance withArticle 10.6.
1. Member toAgreement notifying: CANADA
Ifapplicable, name oflocalgovernment involved (Articles 3.2and7.2):
2. Agency responsible: Health Canada
Agency orauthority designated tohandle comments regarding thenotification canbe
indicated ifdifferent from above:
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): Drugs
5. Title, number ofpages andlanguage(s) ofthenotified document: Proposed Amendment
totheFood andDrug Regulations -Schedule No.979
6. Description ofcontent: ThisAmendment revokes Division 10oftheFood andDrug
Regulations, thereby eliminating theassignment ofanumbered certificate ofregistration
(GPnumber) forproprietary medicines.
Division 10oftheRegulations wasintroduced inthemid-1970s inorder to
regulate thesaleofproprietary medicines. These medications areintended for
self-medication torelieve thesymptoms ofminor self-limiting ailments. Atthattime, it
wasdetermined thatspecial attention begiven tothesafety oftheingredients atthe
dosages andunder theconditions ofuserecommended. Under thecurrent legislation, an
application foraGPnumber must beaccompanied byadditional information which may
include:
Details oftheplant andequipment usedinmanufacturing,
- reports ofinvestigations conducted todetermine thetoxicity ofthedrug
andsubstantial evidence oftheeffectiveness ofthedrug under the
conditions ofuserecommended bythemanufacturer.
./.G/TBT/Notif.97.245
Page2
6. Description ofcontent (cont'd):
Based ontheestablished lowriskassociated withGPproducts, theneed for
manufacturers tosubmit additional information hasdiminished andDivision 10ofthe
Regulations isconsidered unnecessarily restrictive. Furthermore, thecurrent legislation
requires theissuance ofasperate GPnumber forproducts differing from eachother only
inflavour, fragrance orcolour.
TheHealth Protection Branch proposes toregulate alldrugproducts byrequiring
themanufacturers toapply foraDIN. TheRegulations prohibit amanufacturer from
selling adrug product unless avalid DIN hasbeen assigned andnotcancelled.
Consumer drugproducts currently possessing valid GPnumbers willbeassigned DINs
administratively upon review ofanapplication cross-referenced totheir existing file.
The Therapeutic Products Programme isexploring mechanisms tofacilitate the
registration offormer GPproducts asDIN registered drugs without presenting a
financial hardship toexisting manufacturers.
7. Objective andrationale: Remove anunnecessary burden onmanufacturers and
streamline thedrugreview process
8. Relevant documents: Canada Gazette, PartI
9. Proposed dateofadoption:
Proposed dateofentry intoforce:Notstated
10. Final dateforcomments: 31August 1997
11. Texts available from: National enquiry point [X]oraddress andtelefax number ofother
body: