Selection of EU assets includes: identifying, qualifying, auditing and approval of resources. Technical agreements will be required between all parties involved.
Selection of EU batch release site and QP
JensonR+ Ireland holds an MIA for QP certification of imported medicinal products and we have experienced EU qualified QP’s to help with this process. During this stage of the process an audit of the manufacturer of the product would need to be undertaken. They will also need to be added as a contract manufacturer on the MIA. Sufficient time needs to be allowed for these activities and also consider time needed to train the QP so they are familiar with the product.
Selection of EU QC test site
As per EU Regulations sampling must take place after the product has arrived in the EU. JensonR+ Ireland has a range of contacts and can assist with the selection and audit process. We can also provide services to provide a technical justification of alternative sampling approaches. Consideration must be given to the capacity of the QC test sites and the medicinal products that are being transferred. The test site must be successfully audited and added to the MIA. Sufficient time needs to be allowed for these activities, in addition to time needed for method transfers.
Physical site of importation into EU
It is imperative to find a storage site that holds its own MIA for importation, the site will also need to be successfully audited and added to the MIA. JensonR+ Ireland can assist in reviewing storage and transport conditions for current products and qualifying storage sites. Do consider that sampling (as discussed above) will need to be completed at the EU approved site. Technical agreements will be required to cover the relationship between the batch release site and the site of physical importation.
Selection of EU based QPPV
The procedure to change a QPPV is electronic and therefore relatively quick, however, it is important not to underestimate the time required for associated activities. This will include ensuring an SDEA is in place and the PSMF is updated if specific UK address is mentioned in the core as the location of the PSMF. JensonR+ Ireland has an experienced EU based QPPV that can offer services to you for this process.
Selection of EU based MAH
Another pressure point of the process will be transferring the MAH to an EU holder, transfer of UK RMS to an EU/EEA based RMS and for clinical trials, transfer of any UK based sponsor or legal representative and the site of batch release to EU/EEA.
Through our sister company JensonR+ Ireland can provide this service to clients.