Guidance

Authorisations and procedures required for importing Investigational Medicinal Products to Great Britain from approved countries

Updated 22 December 2021

1. Introduction

Investigational Medicinal Products (IMPs) imported into Great Britain from a country on the ‘approved country for import’ list that have been QP certified in a country on the list will not require recertification in Great Britain.

From 1 January 2022 a UK Manufacturing and Import Authorisation (MIA(IMP)) will be required to verify that these IMPs have been certified by a Qualified Person (QP) in a listed country (the ‘oversight process’). This guidance describes what existing authorisation holders and new applicants should do to put procedures in place for the oversight process. It also describes how to apply for the required authorisation.

If you import an IMP into Great Britain from a country on the list, you will need to hold a UK Manufacturing and Import Authorisation (MIA(IMP)) that authorises import.

The authorisation should specify “Importation of QP certified IMPs from a country on the ‘approved country for import list’” as free text within “Other importation activities” in section 2.3 of the licence.

The UK MIA(IMP) holder responsible for the oversight process should be named on the Clinical Trial Authorisation in addition to the listed country site of final batch certification.

An oversight process under a UK Manufacturing and Import Authorisation (MIA(IMP)) is not required when:

• QP certified IMPs are supplied from the EU/European Economic Area (EEA) to Northern Ireland
• QP certified IMPs are supplied from the EU/EEA for use at Northern Ireland clinical trial sites and are then onward supplied to Great Britain
• IMPs are QP certified by a Northern Ireland MIA(IMP) holder

2. Existing UK MIA(IMP) holders with authorisation for importation from third countries

Procedures should be in place for management of importation and QP certification of IMPs from third countries. It is expected that these systems will be readily adaptable to oversee import of finished IMPs from approved countries. A variation to the MIA(IMP) should also be submitted as described above to add oversight of importation from approved countries.

If the licence holder intends to implement this oversight system the Pharmaceutical Quality System (PQS) requirements for the new process (as described in section 5) should be put in place as soon as possible before 1 January 2022.

3. Existing UK MIA(IMP) holders without authorisation for importation from third countries

A variation to the MIA(IMP) should be submitted to request authorisation for the oversight of importation from approved countries.

The licence holder should have procedures to manage and document the oversight process (as described in section 5) and these should be ready for inspection at the time of application. This inspection may be initially conducted remotely, but this may later require an on-site inspection.

4. New applications for a UK MIA(IMP) solely for the purposes of the oversight of import of IMPs from approved countries

If no MIA(IMP) is held then an application for a UK MIA(IMP) will need to be submitted. This may be limited to oversight of IMP import from approved countries.

The PQS should provide a robust mechanism for the oversight process (as described in section 5). An inspection will be performed prior to granting of the licence. This inspection may initially be conducted remotely, but this may later require an on-site inspection.

As the oversight process does not involve any manufacturing, packaging or testing activities, there is no requirement to name a person responsible for production. A person responsible for the overall Quality System (QC) and a suitable QP must be named.

5. Expected parts of a PQS to support the oversight process

The PQS solely for the purposes of the oversight of import of IMPs from approved countries should include, but is not limited to the following:

• Procedures for the preparation, revision and control of documents (procedures, specifications and records).
• Management of Product Specification Files (not all detail in the PSF will be required, but relevant information should be available and maintained up to date).
• Training of staff involved in the process, including appropriate experience with IMPs.
• Procedures for management of deviations, change control, corrective and preventive action (CAPA), complaints, recall, self-inspection, management review.
• Written agreements with relevant parties, including clinical trial Sponsor, distribution partners and storage sites as applicable.
• Procedures for status control of shipped IMPs. Responsibilities of each party should be defined in technical agreements, and proportionate controls should be in place. If IMPs are shipped directly to the trial site there should be a robust mechanism to ensure that product is held until notification is provided to the site that the IMP is approved for use.
• Formal documentation of any tasks delegated by the QP to appropriate personnel operating within their MIA(IMP) quality system.

There is no requirement to re-certify batches already QP certified in a listed country, or for the QP named on the UK MIA(IMP) to maintain a register of certified batches. Records of all shipments to trial sites in Great Britain using the oversight process should be visible within the PQS and be traceable.

6. Assessment of applications

MHRA will assess variations and new MIA(IMP) applications within 90 days of submission. Appropriate licence updates and new application submissions should be made in a timely manner to ensure that authorisations are approved prior to 1 January 2022. Systems should be in place as practicable to support ongoing activities