The Falsified Medicines Directive 2011/62/EU ("the FMD") modifies EU Medicines Directive 2001/83/EC and from 2 July 2013 introduces new requirements for active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products.

The FMD requires importers of AS 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 (EU GMP). These confirmations are required before importation of ASs into the EU.

The FMD provides 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 (EC) as equivalent to EU GMP (listing). 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.

From the 2 July 2013 the new requirements for active substances (ASs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products must be complied with.

The MHRA acknowledges that the introduction of these additional requirements may in some instance make the sourcing of ASs from some third countries difficult. The MHRA is therefore developing contingency plans that would allow the Agency, in cases where there is an overriding need to ensure continued supply of specific ASs after 2 July 2013, to provide an opinion on the importation of the AS to permit manufacture, QP certification and supply of finished medicinal products. The aim of these contingency plans is to ensure, as per the aims of the Falsified Medicines Directive, the continued supply of ASs of appropriate quality and maintain the responsibility for the quality of the authorised medicinal products with the manufacturer, as is the case under the current legislation in force.

Therefore for the short term only and where:

1. The third country AS manufacturing site is not covered by a written confirmation, and
2. the exporting country has not been assessed by the EC as having standards equivalent to EU GMP and
3. the third country AS manufacturing site is not the subject, following inspection, of a current certificate of compliance with EU GMP,

the MHRA will be seeking evidence in the form of a submission / declaration completed by the Manufacturing Authorisation Holder ("MIA Holder") that:

1. the AS manufacturing site has been audited in the last three years either by himself or by a third party acting on his behalf and found to be operating in compliance with EU GMP for active substances  and
2. the third country AS manufacturing site is the subject, following inspection, of a current certificate of compliance with GMP issued by a recognised national authority or international organisation e.g., US-FDA, EU-MRA partners, EU-ACCA partners, PIC/S member states and the WHO.

MHRA submission template (36Kb)

Where the MIA Holder can make the first declaration but cannot declare that the third country AS manufacturing site is the subject, following inspection, of a current certificate of compliance with GMP issued by a recognised national authority or international organisation then the MHRA intends to enter details of the third country AS manufacturing site onto a database of pending GMP inspection of a third country AS manufacturing site.

The MHRA will conduct further assessment of the data supplied in the submission(s) at the next routine re‑inspection of these finished product manufacturing sites.

The entry on the database will be removed if the AS manufacturing site and the AS subsequently become the subject of a written confirmation, the third country has been assessed as having standards equivalent to GMP, or the AS manufacturing site, following inspection has been issued with a certificate of compliance with EU GMP. The pending‑inspection database will only be available as long as this is required as a contingency measure.

Importers of ASs are also asked to note that where the sourcing of ASs from some third countries is difficult because it is not covered by a written confirmation, the exporting country has not been assessed as equivalent and the AS manufacturing site is not the subject of a valid GMP certificate, these circumstances are subject to on‑going review coordinated at an EU level. A key element of this review is the gathering of further data from EU‑based finished product manufacturers for AS import risk assessment and, where required, the EU level coordination of third country AS manufacturer inspections.