The EU currently consists of 28-Member States; each has its own market nuances for transportation and distribution of pharmaceutical materials that will need to be addressed. There is significant complexity to navigate in determining a commercialisation strategy for the EU, supply chain mapping and optimisation of the supply chain structure to facilitate GxP compliance can deliver significant financial savings over the life cycle of a product.
MIAS takes a two-phase approach to supply chain mapping for our customers:
- Initially MIAS facilitates experts on EU Law and Taxation to work with our client to define the ideal EU Entity structure from a legal and financial perspective to maximise tax benefits and R&D rebates in Europe for current and future product lines.
- Once the legal / taxation session is complete MIAS then delivers a workshop to define the detail of the supply chain structure and to identify GxP licensing requirements that will apply across that supply chain in the EU and the Clients EU entity. Typically, supply chain mapping workshops are carried out through face-to-face engagement, however, as clients are often located in multiple locations interactive video conference sessions are often utilised for convenience.
In preparation of this workshop we advise our clients to consider:
- Identifying the Tier 1 EU Markets into which your company plans to supply.
- Consider how materials and drug product are to be moved into and out of the EU. Both physical and financial ownership of materials need to be mapped with reference to one another. Financial transactions can move in many ways to maximise the tax benefits and do not need to mirror the physical movement of the materials/ product.
- Identify exactly where in the supply chain title/ ownership changes for the materials product involved. This influences GXP licensing requirements in individual Member States.
- Who are the parties responsible for transportation and security and identification of where responsibilities for transportation and security start and end for the individual parties in the supply chain. This influences GXP licensing requirements in individual Member States.
- Identify holders of Marketing Authorisations in individual Member States. This influences the responsibilities of Client for the finished product.
Oversight and Compliance
“It is the ultimate responsibility of the MAH to ensure that the medicinal product is designed and developed ethically, taking into account the requirements of Good Manufacturing Practices and Good Laboratory Practices. Ensuring the security and GMP compliance of the entire manufacturing supply chain is an important responsibility of the MAH to ensure appropriate and continued availability of medicinal products for human use to meet the needs of patients in accordance with Article 81 of Directive 2001/83.”
On request, MIAS can work with your company’s existing service providers and provide a turnkey solution including selection and qualification of the most appropriate alliance partners for each stage of the project and provide full project management & oversight of the supply chain to ensure that best practice is maintained by all suppliers.