The UK MHRA has issued new guidance on authorisations and procedures required to Import Investigational Medicinal Products (IMPs) from countries on a list, to Great Britain (GB).
Information is also provided on the importation of authorised/unathorised:
- non-investigational medicinal products
- unmodified comparators to be labelled in Great Britain prior to QP certification and release to the clinical trial,
A summary of the guidance is provided below. Refer to the guidance for full details.
1. Introduction
The requirements and procedures for clinical trials in the UK are set out in the Medicines for Human Use (Clinical Trials) Regulations 2004. These regulations:
- require all interventional clinical trials to be ethically approved and authorised by the MHRA.
- also include requirements for the application and assessment of each trial, the supply of investigational medicinal products (IMPs), the conduct of clinical trials in accordance with good clinical practice and safety reporting.
The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations amend the Medicines for Human Use (Clinical Trials) Regulations 2004 to enable the MHRA to operate as a regulator outside the EU, post Brexit.
Detailed guidance on the manufacture and import of IMPs are described in Eudralex Volume 4 and Eudralex Volume 10, including guidance for the issuance of the Qualified Person Declaration for the importation of IMPs manufactured in third countries outside the EEA.
2. Import of IMPs from an approved country
A Sponsor of a UK clinical trial using IMPs imported into GB from countries on an ‘approved country for import’ list (initially, all EU and EEA countries) will require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to put in place an assurance system to check that these IMPs have been certified by a Qualified Person (QP) in a listed country, before release to the trial.
3. Oversight process
There are two routes for IMPs to be received into GB from a listed country for use in UK clinical trials following QP certification by the listed country MIA(IMP) holder:
- direct to the GB clinical trial site
- via a GB storage and distribution ‘hub’.
Suitable for different supply chain relationships are listed in the guidance. Only one of these pieces of evidence is sufficient to satisfy the requirements of the Regulations. Other evidence may be acceptable provided it confirms that QP certification has taken place for the batch in question.
3.1 Written agreements
There should be written agreements which describe the assigned responsibilities and provision of relevant information between the organisations. These include agreements concerning any/all of the following as/if applicable. See guidance for further details.
- sponsor
- UK MIA(IMP) holder responsible for the oversight of import from the listed country
- sponsor
- listed country MIA(IMP) holder
- Great Britain storage and distribution hub
3.2 Documentation available to the QP named on the UK MIA(IMP)
The QP named on the UK MIA(IMP) should have the necessary documentation available as part of the oversight process for import of IMP to GB from listed countries.
A non exclusive and non-exhaustive list of the required documents is provided in the guidance. This is because information requirements may vary depending on the responsibilities of each organisation in the supply chain.
3.3 Acceptable evidence of QP certification
Written evidence should be available to demonstrate that each batch of IMP imported from a listed country has been QP certified for use in the specified UK trial. This should be verified prior to the first shipment of IMP from each batch to the GB trial site(s).
4. Supply of IMP to a Great Britain clinical trial site
- Until the QP named on the UK MIA(IMP)confirms that the batch of IMP has been appropriately certified by the listed country QP, the IMP should not be made available for use by the GB trial sites. This is in addition to the two-step release procedure described in EU GMP Annex 13.
- Regulatory release of the IMP may be given for some countries at different times therefore the Sponsor should ensure the regulatory release is in place for the UK prior to IMP being made available for use in the trial.
5. Using a Great Britain storage and distribution ‘hub’
- You may use a distribution facility to store IMPs imported from a listed country before supply to GB clinical trial sites.
- IMPs may be imported to the distribution hub from a listed country prior to confirming that QP certification has taken place in the listed country if they are segregated electronically or physically until certification has been confirmed by the QP named on the UK MIA(IMP).
- GB storage and distribution facilities should be named on the UK MIA(IMP) of the company responsible for oversight of the import.
6. Reference and retention samples
- Whilst additional reference and retention samples are not specifically required to be stored within GB, the storage location should be visible to the QP named on the UK MIA(IMP)and defined in the written agreement with the Sponsor.
- Provision for timely access to the samples by the UK competent authority should be made within the relevant written agreements.
7. Importing non-investigational medicinal products for use in a clinical trial
| Item(s) imported | Country imported from | Requirement(s) |
|---|---|---|
| Authporised/unauthorised: -non IMPs -unmodified comparators to be labeled in GB prior to QP certification and release to the clinical trial | Listed country | Should use a wholesale dealer’s licence (WDA(H)). A Responsible Person for import (RPi) may be required. Guidance is available on the above. Eligibility criteria for RPi updated on 7 July 2021. |
| Same as above | Non listed country | A manufacturers licence |
| Non IMPs | Northern Ireland | Will require a WDA(H), unless you are the Sponsor of the clinical trial. |
Source: MHRA website