Best Practice Guide for advice from CMDv on regulatory matters

During a recent variation of a marketing authorisation for a generic product of the already authorized veterinary medicinal product (VMP) ‘NUFLOR 300 solution for injection for cattle and sheep’ a potential serious risk for the environment was identified. Consequently, the EU Member States decided to add warning sentences concerning the precautions for the use of the VMP. The sentences were discussed between EU Member States involved in the procedure, the CMDv including experts on environmental risk assessment. As a result, the Member States achieved an agreement on warning sentences that should be mentioned in the SPC/PI of all the VMPs concerned. Indeed, the active substance contained in the VMP may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms and as such, the VMP should not enter water courses.

CMDv letter to MAH – Florfenicol

Translations

In accordance with Art. 65 of the ‘Regulation’, it is mandatory to submit a work-sharing application to the NCAs in all relevant Member States where one or more VRAs identically apply to one or several marketing authorisations which are held by the same MAH, and which have been granted by different NCAs or by the Commission. Industry is reminded to follow this principle whenever applicable.

In case the above requirement is not followed, the NCAs will request the MAHs to withdraw the procedure from all Member States and to re-submit the VRA in a work-sharing procedure. Furthermore, in case one or several marketing authorisations were not included in the work-sharing procedure or in case the VRA was already approved nationally in a Member State then the procedure must be re-submitted as a work-sharing procedure to all Member States including those ones where the variation is already approved.

For more information on the work-sharing procedure including the rules for the submission of such procedures, please see the CMDv website.

Following the outcome of the above-mentioned referral procedure the final Commission decision proposes amendments to relevant sections of the product information as stated in Annex III (please find below). Generally, the implementation ofthe changes is done by submitting a variation not requiring assessment.

After having received several requests from Marketing Authorisation Holders it has been recognised that, unfortunately, two aspects of Annex III concerning section 3.4/4.4 as well as section 3.12/4.11 seem to leave room for different interpretations, which could lead to different outcomes of VNRAs depending on the MAH and the responsible NCA.

To avoid disharmonisation the CMDv wants to provide advice with regard to the respective sections of the product information.

1. Advice on section “Special warnings” - Warnings due to low susceptibility/possible resistances (3.4/4.4)
2. Advice on section “Withdrawal periods” (3.12/4.11)

Link to advice from CMDv

Link to the Commission decision https://ec.europa.eu/health/documents/community-register/html/vo28111.htm

In case of doubt, it is recommended that the relevant reference Member State or national competent authority is consulted prior to submission of a C.2 VNRA to implement the Commission decision in order to avoid rejection of the VNRA due to the proposed amendments not being appropriate/acceptable. The change can also be submitted as variation requiring assessment (VRA code G.I.1.z).

In case of further questions please be advised to refer to the respective Reference Member State or National Competent Authority of your product.