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Exception handling for MAHs

The following article describes the exception handling process we recommend for MAHs in Norway.


This article was last updated February 13th, 2019 at 12:28 pm

Introduction

Exception handling is an important topic for all involved in the implementation of DR 2016/161.

MAHs can either receive an alert from the system, or be contacted by an End-User or NOMA. The described process is a recommendation, and should be used as a guide for MAHs to develop their procedures to support the Norwegian market.

More information from NOMA can be found here (Norwegian).

Temporary measures

NOMA has been involved in developing a soft launch approach to allow time for the new processes to be established, and has approved certain measures for a transition period. NOMA will monitor the implementation of the use of the verification process and effects upon the supply chain to determine for how long the transition measures will be allowed. Please refer to NOMA to make sure you are aligned with the latest regulations.

The temporary measures include:

For PHARMACIES:

  • NOMA has approved that GTINs without batch data in the NMVS may be excluded from verification and dispense for a transition period

For ALL END-USERS:

  • For a limited time during the implementation of the system only a limited number of codes will be expected to need further investigation before the product is dispensed. A list of these codes can be obtained from NOMA.

Exception handling flow chart

This article is relevant for:

For Marketing Authorization Holders

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