Written Confirmations for export of Active Substances manufactured in the UK
Updated 23 August 2019
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1. Purpose of the Written Confirmation
A Written Confirmation confirms that, for a third country exporting Active Substances to the EEA:
- the standards of Good Manufacturing Practice (GMP) are equivalent to those in the EU/EEA
- the manufacturing plant is subject to regular inspections (which may be both announced and unannounced)
- significant non-compliance events would be communicated to the EEA without delay
A template for the Written Confirmation can be found on the European Commission website.
The requirement for the Written Confirmation is stated in Article 46b(2)(b) of Directive 2001/83/EC.
2. ‘Third Country’ status for UK manufacturers of Active Substances
In a no-deal Brexit, the UK will be recognised as a Third Country for the export of Active Substances for human use to the EEA.
A Written Confirmation will then be required for each shipment of Active Substances manufactured in the UK that is exported to the EEA.
3. Generation of Written Confirmations for Active Substances manufactures in the UK
You will not need to provide any information to the MHRA to allow the Written Confirmation to be generated. All the information required for the Written Confirmations is available within MHRA systems.
Written Confirmations will be generated for UK Active Substance manufacturers whether they intend to export Active Substances or not.
The Written Confirmations will be published on the MHRA’s website and will be available for you to download, as and when required. This will support your export of Active Substances for human use to the EEA.
3.1 . Biological products
Manufacture of biological active substance is considered to be partial manufacture of the biological medicinal product. These activities are recorded in section 1.3 of the UK Manufacturing Authorisation (MIA) and the associated GMP certificate issued following a satisfactory inspection “(EU Interpretation of the Union Format for Manufacturer/Importer Authorisation)”.
If you hold an MIA that includes manufacture of biological active substance, separate registration as an active substance manufacturer is not required. No written confirmation will be issued, as this is already confirmed by the MHRA GMP certificate.
4. Obtaining Written Confirmations for Active Substances manufactured in other third countries
There will be no change to the requirements for obtaining Written Confirmations for importation of Active Substances from other ‘Third Countries’. You will still need to obtain the Written Confirmations from the issuing authority in that country.
5. Requirements for distributors of Active Substances
If you are a Distributor of Active Substances that you did not manufacture, Written Confirmations will not be generated for your activities. If a Written Confirmation is required for export activities, it can be obtained from the appropriate issuing authority, or directly from the manufacturer.
6. Provision of Written Confirmations for each shipment of Active Substances exported to the EEA
A ‘Questions and Answers’ document on the EU expectations relating to Written Confirmations is available on the European Commission website. This document identifies how the Written Confirmation should be provided to the customer within the EEA.
7. Validity period of a Written Confirmation
A Written Confirmation is valid for a period of 3 years from the starting date of the last inspection. Where required the MHRA will offer an assessment to reissue GMP certificates of UK Active Substance manufacturing sites, prior to a no deal departure from the EU, to allow generation of Written Confirmations with an appropriate validity period.
8. Companies with confidential GMP certificates
If your company has a confidential GMP certificate due to the nature of the Active Substances manufactured, the Written Confirmation will not be published on the MHRA website. The Written Confirmation will be sent to the contact named on your Active Substance registration.
9. Requirement for both a GMP certificate and a Written Confirmation
Although similar information is contained in a GMP certificate and a Written Confirmation, both documents serve different purposes:
- UK law requires a GMP certificate to be issued after an inspection
- EU regulations require a Written Confirmation for any import of Active Substances into the EEA by a Third Country
If you export Active Substances made in the UK to the EEA, you are therefore required to have a valid GMP certificate and a valid Written Confirmation.
10. Ongoing requirement for Written Confirmations
The need for Written Confirmations is expected to be an interim position. At a suitable point after Brexit, an application will be made to recognise the UK’s GMP standards for the manufacture of Active Substances in the UK as equivalent to those in the EU.
Once a country has been accepted as having equivalent GMP standards, they are added to a ‘White List’ and Written Confirmations are then no longer required.