TBT BSN | Notification

Notification Detail :: G/TBT/N/ARG/52

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

National Drug, Food and Medical Technology Administration (ANMAT) Resolution No. 2814/2002  (two pages, in Spanish).

Objective

Product Covered

Medicinal preparations for human use

Document Notification

Link to ePing

HSCODE

ICSCODE

Keywords

Specific Regions

Description

It is internationally accepted that there is a group of medicinal preparations which are considered to be equivalent in view of the characteristics of their pharmaceutical form and/or the means by which they are administered.  Since one of the objectives of bioavailability studies is to determine the rate of absorption of an active ingredient, there is no need for such studies to be carried out for products administered via the parenteral, pulmonary, topical, dermal or mucosal routes or solutions for oral administration.  By reason of the above, it should be specified more precisely that medicinal preparations are exempt from the requirement to conduct equivalency studies.

Notified Document

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/ARG/52

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