Are you ready for the post-Brexit model? Time is running out to get things in order.

We have created a timeline to help identify where your pressure points may lie.

Supply Chain Assessment

Exploring the current supply chain and identifying any procurement risks, their potential outcomes and providing solutions to mitigate them.

Selection of EU Assets

EU legislation requires these elements to be in place in order for supply of medicines into the EU:

  • Selection of EU batch release site
  • Selection of EU QC test site
  • Selection of physical site of importation into EU
  • Selection of EU based QPPV
  • Selection of EU based MAH
  • Method transfer to EU QC test site

MAH Set-Up

EU legislation requires these elements to be in place in order for supply of medicines into the EU:

  • MAH transfer to EU based MAH (QP declaration required)
  • Serialisation set up for MAH

EU Batch Release and MAH Activities

Go live with batch release and MAH activities for EU

As a company, JensonR+ Ireland can offer a holistic solution to meet the EU requirements; from completing a Supply Chain Assessment to providing an EU QP and QPPV services and holding your MAH’s.

Considerations for Activities

JensonR+ Ireland can offer a Supply Chain Assessment. Analysing your current supply and where there may be issues that need addressing. Our experienced team can help identify and rectify these problems and support you through the process.

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.

EU legislation requires these elements to be in place in order for supply of medicines into the EU. This will involve audits of the supply chain, in order to provide the QP declaration and ensuring serialisation connections are set-up and qualified appropriately, if required.

Paul Quinn
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