MHRA Contingency Plan for API Import

Recommendation

7/8 May 2024

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Hardly any other subject is as extensively discussed in the GMP environment as the so called Written Confirmations. As of 2 January 2013, all active substances (AS) have to be manufactured in accordance EU-GMP, or (if imported) with equivalent rules.

Starting from 2 July 2013, all APIs manufactured outside the EU have to be accompanied by a Written Confirmation, otherwise they cannot be imported into the EU. But there are 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 (and are listed accordingly). The second is an exceptional waiver intended to apply where it is necessary to ensure the availability of medicinal products.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has now published a Contingency Plan for the latter case:

for the short term only and where:

• The third country AS manufacturing site is not covered by a written confirmation, and
• the exporting country has not been assessed by the EC as having standards equivalent to EU GMP and
• 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:

• 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
• 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.

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.

Source: Medicines regulatory news