Consultation procedure about medicinal products and safety measure requirements not completed yet

03 October 2014

On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation.

The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists.

We have received 22 consultation responses.

But on 24 September 2014 the European Commission amended the original guideline for how to interpret the criteria used to assess whether a medicinal product is qualified for the white list.

Based on the amended guideline, we have to make a new assessment of the products we recommend including in the Commission's white list.

As a result of this new assessment, the draft white list included in the consultation of 5 September 2014 may be changed. We have not yet completed the new assessment, but we expect that the white list will be shorter as a result of the Commission's amended guideline.

We will inform the respondents of our final recommendation to the Commission's white list when we have completed the assessment.

Did you get answers to your questions?

Please tell us how we can improve our website? Please note that we do not answer questions asked via this feature.