Regulation amending the Regulation on special conditions for performing tests, method of control and storage of drugs used in veterinary medicine.
Country
Type of law
Regulation
Abstract
This Regulation amends certain provisions part of the Regulation on special conditions for performing tests, method of control and storage of drugs used in veterinary medicine (originally published in the Official Gazette of the Federation of Bosnia and Herzegovina 44/1999).
Changes are related to the contents of article 8 (paragraph 2: added indications on examination documentation that has to be carried out by manufacturer, for the purpose of drug registration). Also a new article (17a) is here added: "In the event that there are no conditions for performing clinical trials, specified in Articles 13 to 17 of this Regulation, recognized documentation of clinical trials carried out by the manufacturer for the purpose of marketing authorization shall be provided".
Changes are related to the contents of article 8 (paragraph 2: added indications on examination documentation that has to be carried out by manufacturer, for the purpose of drug registration). Also a new article (17a) is here added: "In the event that there are no conditions for performing clinical trials, specified in Articles 13 to 17 of this Regulation, recognized documentation of clinical trials carried out by the manufacturer for the purpose of marketing authorization shall be provided".
Attached files
Web site
Date of text
Entry into force notes
This text entered into force on the day after its publication in the Official Gazette.
Repealed
No
Publication reference
Official Gazette of the Federation of Bosnia and Herzegovina 57/2009
Source language
English
Legislation Amendment
No
Original title
Pravilnik o izmjenama i dopunama Pravilnika o posebnim uvjetima za obavljanje ispitivanja, načinu kontrole i čuvanja lijekova koji se upotrebljavaju u veterinarstvu.