Are you considering conducting a clinical trial in the UK but have concerns about additional complexities of IMP importation? As an authorised importer of Investigational Medicinal Products, Simbec-Orion works with biotech and pharmaceutical clients to conduct clinical research internationally and have an experienced and knowledgeable regulatory team to ensure seamless IMP importation for your clinical trial.
Will my IMP require recertification if I’m conducting clinical research in the UK?
Not if you are importing IMP from the UK’s approved country for import list (all EU and EEA countries). If the IMP has been certified by a Qualified Person (QP) in an approved country, it will not require recertification.
What is the process for importing IMP into the UK from an approved country?
An assurance system has been put in place to check the IMP has been certified by a QP. This needs to be conducted by a holder of a UK Manufacturing and Import Authorisation, such as Simbec-Orion.
What if my IMP has been manufactured in a country that is not on the UK’s approved countries list?
The MHRA specifies that any IMP coming directly to the UK from countries not on the approved import list will require import and QP certification in the UK, as per the existing requirements.
What documentation do I need to evidence my IMP has been certified in an approved country?
The MHRA is flexible with documentation requirements, provided the evidence confirms QP certification is applicable to the batch being imported. Examples include:
- QP batch certificate
- Statement of certification (ad-hoc, confirming certification in accordance with Clinical Trial Regulation)
- Access to the certifying MIA(IMP) holder’s internal systems (e.g. global Enterprise Resource Planning system) that confirms batch certification
If you are unsure, our dedicated regulatory team can assist you with IMP importation queries.
Can I contract IMP importation without other CRO services?
Simbec-Orion offers flexible service delivery and can accommodate all your study requirements, whether you are looking for a full-service CRO partner or prefer to contract specific standalone services. Simbec-Orion will shape their services and delivery around your requirements.
If you’d like to speak to one of the team to find out how Simbec-Orion can help with IMP importation, contact us at [email protected] or find out more information on the MHRA website here: Importing Investigational Medicinal Products (IMP) from countries on a list to Great Britain – GOV.UK