New requirements for active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products have been introduced today under the Falsified Medicines Directive 2011/62/EU (the FMD). The FMD requires importers of ASs to obtain written confirmations from competent authorities in non-EEA countries (third countries) that the standards of manufacture of ASs at manufacturing sites on their territory are equivalent to EU Good Manufacturing Practice (GMP). These written confirmations are required before ASs are imported into the EU.
A summary of the overall process has been developed and is available on the following website: HMA – Falsified medicines (external link)
The EMA will publish information on the process in the next few days. The UK will not control AS import at the border and will instead control at inspection of manufacturers and, where there is a risk trigger, at inspection of AS importers and distributors.
The FMD allows for two waivers if written confirmations are not provided. The first is where the GMP for ASs in those third countries has been assessed by the European Commission as equivalent to EU GMP (listing). Details of countries who have applied for listing and countries that have successfully completed this process are on the European Commission website.
- Quality of medicines and Good Manufacturing Practices (GMP) – importation of active substances (external link)
The second is where the third country AS manufacturing site has been inspected by an EU member state and issued a certificate of compliance with EU GMP. This is an exceptional waiver intended to apply where it is necessary to ensure the availability of medicinal products. In accordance with the legislation (Article 46b(4), MHRA has notified the European Commission of its intent to use the possibility of this waiver.
- Letter from the MHRA notifying the European Commission of its intent to use the possibility of using the waiver contained in Article 46b(4) of Directive 2001/83/EC (67Kb)
UK based companies (registered importers and manufacturers who also import directly) who wish to import ASs under this waiver should apply to firstname.lastname@example.org using the form below.
- Application Form for a waiver from the requirement to supply Written Confirmation with consignments of an imported Active Substance on the basis of a GMP certification of the Active Substance Manufacturer by an EEA Member State
Imports transiting Germany
When the ASs first enter the EU and transit other Member States before they arrive in the UK, the UK based importer will need to comply with the requirements of those Member States and may need the assistance of locally-based importers. If an AS is imported via Germany under the second waiver, the import requirements are applied at the border. In this case, the importer must apply to the relevant competent inspectorate in Germany for a ‘72a Certificate’. As part of this application, the importer will have to provide written justification to the German inspectorate for the absence of a Written Confirmation and include a copy of the GMP certificate. The importer who applies for the ’72a certificate’ is normally based in Germany and will contact the local German inspectorate to clarify details.UK importers are advised to arrange such imports in conjunction with a German importer. If the local process is not followed, it could result in consignments being held in Germany.
Find out more about the new requirements for active substances: