Division 1 Definitions

Laboratory designated by a Member State of the EU or Israel as referred to and regulated by pharmaceutical legislation and guidelines of the EU, the Council of Europe and Israel to perform laboratory testing for a competent authority, independently from the manufacturer, for medicinal products prior to and/or after marketing for the general surveillance of medicines in relation to the safety of human patients and/or animals.

Requirement by a Party, as referred to and regulated by pharmaceutical legislation and guidelines of the EU, the Council of Europe and Israel, that an Official Medicines Control Laboratory determines the conformity of a batch with the approved specifications as laid down in the marketing authorisation before the competent authority of the Party will allow that batch to be marketed. The examination includes testing on a schedule as defined in the guidelines referred to above.

Testing of medicinal products imported from a third country or the other Party including a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation.