The European Boards of Health (BOH) seek to ensure that any licensed medicinal products brought into the EU by non-EU manufacturers meet EU law to ensure patient safety and product efficacy.
Manufacturing and Importation Authorisation (MIA)
To bring licensed medicines into the EU from outside the EU there must be a Manufacturing and Importation Authorisation (MIA) in place. A qualified person (QP) must also be employed to approve the overseas manufacturing site and be responsible for batch release of product.
The BOH audits the MIA holder to ensure a suitable quality management system (QMS) is in place and adheres to cGMP, they will also ensure a suitable responsible person (RP) and QP oversee the system.
Wholesale Distribution Authorisation (WDA) / Wholesale Dealers Licence (WDL(H))
Once received in the EU, a Wholesale Distribution Authorisation (WDA) is required before product can be distributed. The WDA lists the types of medicines the holder is authorised to handle.
Facilities and systems audit will be undertaken to ensure the warehousing and/or distribution centre to be used meet acceptable criteria for the type of medicinal product listed (e.g. sterile, non-sterile, biological, herbal, homeopathic, APIs, finished products).
The facility will need to have sufficient systems in place usually outlined in a Site Master File (SMF) and the QMS. These will cover areas such as temperature and humidity control, cleanliness, storage areas for products, personnel involved in the process, and procedures to cover issues such as complaints, recalls, deviations etc.
Additional legal requirements
- An EU address must be provided for the Marketing Authorisation Holder (MAH), MIA, WDL and warehousing.
- A pharmacovigilance (PV) contact must also be provided for adverse event reporting. PV providers must all be in receipt of cGPV authorisation from an EU BOH. WBR work with EU and UK based partners to provide all PV requirements.
- Laboratory testing services must also be engaged to ensure full release testing is provided including batch release and identity testing, product quality specification (PQS), stability, and storage indication testing.
All laboratory testing facilities must hold cGMP accreditation. WBR have collaborative partnerships with specialist testing houses who can provide all testing requirements for release of pharmaceutical products. WBR QPs are enlisted to be cited on client licences to review batch records and release product on their behalf.
WBR hold an MIA and WDL and have been audited by the UK MHRA and been granted cGMP accreditation for its importation, warehousing, and distribution services.
WBR works with non-EU manufacturers to help them import product into Europe whilst incurring minimum cost as they can use our facilities and resource in the UK to start to import and sell product in Europe before setting up their own facilities.