An NSF International Company MHRA API contingency plan
Monday the 20th May 2013
From 2 July 2025 the new requirements for active substances (APIs) imported into the European Economic Area (EEA) for use in the manufacture of authorised medicinal products must be complied with.
The UK MHRA has today published a contingency plan to avoid shortages of vital medicines post 2 July 2025 due to APIs being unavailable because of problems in complying with these new requirements of Directive 2011/62/EU, the Falsified Medicines Directive. The plan is as follows:
The MHRA acknowledges that the introduction of these additional requirements may in some instances make the sourcing of APIs 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 APIs after 2 July 2013, to provide an opinion on the importation of the API 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 APIs 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:
a. The third country API manufacturing site is not covered by a written confirmation, and
b. the exporting country has not been assessed by the EC as having standards equivalent to EU GMP and
c. the third country API 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:
a. the API manufacturing site has been audited in the last three years either by the MIA Holder or by a third party acting on his behalf and found to be operating in compliance with EU GMP for active substances and
b. the third country API manufacturing site is the subject, following inspection, of a current certificate of compliance with GMP issued by a recognised national authority or international organisation eg US-FDA, EU-MRA partners, EU-ACCA partners, PIC/S member states and the WHO.
Where the MIA Holder can make the first declaration but cannot declare that the third country API 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 API manufacturing site onto a database of pending GMP inspection of a third country API 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 API manufacturing site and the API subsequently become the subject of a written confirmation, the third country has been assessed as having standards equivalent to GMP, or the API 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 APIs are also asked to note that where the sourcing of APIs 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 API manufacturing site is not the subject of a valid GMP certificate, these circumstances are subject to ongoing review co-ordinated at an EU level. A key element of this review is the gathering of further data from EU based finished product manufacturers for API import risk assessment and, where required, the EU level co-ordination of third country API manufacturer inspections.
It remains to be seen if other EU Member States will put similar plans in place.
