Action required: Consultation period for ‘SPC harmonisation’ ends 29/June/2021.
The CMDv (Co-Ordination Group for Mutual Recognition and Decentralised Procedure – Veterinary) is seeking feedback on its Best Practice Guides (NPGs) related to the New Veterinary Regulation (NVR), coming into effect on 28/January/2022. The Best Practice Guides have either been newly created or are updated accordingly. If you would like to get further information about the NVR itself, please refer to a previous blog here.
The CMDv published the table below, containing a list of documents and deadlines for consultation.
Please note that the CMDv will update the list of available documents as and when appropriate.
As a reminder, the initial objectives of the Regulation (EU) 2019/6 should be taken into account when commenting on the Best Practice Guides. And here more specifically the objectives of reducing administrative burden, enhancing the functioning of the internal market, increasing availability and safeguarding public health, animal health, animal welfare and the environment.
These Best Practice Guides have been prepared by the CMDv to be used during the SPC harmonisation procedures by Reference Member States (RMS), Concerned Member States (CMS) as well as the marketing authorisation holders (MAH), in order to facilitate the SPC harmonisation procedure.
What are the Harmonisation Procedure phases?
The SPC harmonisation procedure for veterinary medicinal products (VMP) can be divided into three phases:
1. Selection phase; MAH as well as Member States (MS) can suggest products to be considered.
2.A Examination phase for the reference veterinary medicinal product; determination whether the acceptance criteria to be eligible for the harmonisation procedure have been met.
2.B National phase for updating the SPC of the reference veterinary medicinal product.
3.A Harmonisation of the SPCs of generic and hybrid veterinary medicinal products.
3.B National phase for updating the SPCs of the generic and hybrid veterinary medicinal products.
According to these procedures National Competent Authorities (NCA) as well as MAHs may propose harmonisation of the SPCs of Reference Veterinary Medicinal Products (RVMPs) for which a marketing authorisation has already been granted.
A number of criteria for the prioritisation of the SPC harmonisation have been identified. However, it is probably disappointing that taking resource limitations within the agency network into account combined with untried and untested procedures, it is estimated that during the first year of implementation only 5-6 veterinary products can be short listed.
What is the impact of the SPC harmonisation on MAHs?
For products that are shortlisted by the CMDv, the CMDv working group on SPC harmonisation will first identify all MAHs with MA from the Union Product Database (UPD). VMPs should have the same active substance as those of the reference VMP. Targeted requests will be sent to MAHs concerned to provide information on the link between the MA of their product and the products identified on the CMDv shortlist.
For the reference VMPs listed in the CMDv shortlist for which the proposal for SPC harmonisation was not made by the MAH themselves, the MAH will be requested to provide the following information on their reference VMPs:
- List of countries where the reference VMP is authorised;
- Product name(s) and name and address of the MAH in all the countries where the reference VMP is authorised;
- Type of marketing authorisation procedure in each of the MS where the reference VMP is authorised;
- MRP number (if applicable);
- MAH contact point for the SPC harmonisation (name, email and telephone number).
MSs might ask for additional information in case – for example – drug safety might be affected.
Comparative table to be submitted by the MAH
The CMDv provides further assistance (shown in the sample table below) to MAHs with regards to the information that should be provided in case the MAH (for each MS) makes a request to shortlist a reference VMP for the SPC harmonisation procedure.
Additional templates for requests are also provided. Users of the Samarind RMS solution have this information available at their fingertips, minimising time and effort spent to collect the right information from multiple sources accurately.
The Best Practice Guidance documents provide a good overview of the process to be adapted for the new SPC harmonisation procedure. Further details describe what MAH and NCA can expect and should provide. The provision of templates will simplify the process, but if you have a solution such as Samarind RMS, the information is already available at your fingertips.
Please keep in mind that the consultation deadline is 29/June/2021 if you wish to share your thoughts on the proposed SPC harmonisation guides.