The proposal is part of an updated plan announced last Friday to minimize the impact laws that – from July 2 - will require that all actives imported to the European Union (EU) are accompanied by ‘written confirmations’ of quality from local regulators.
The agency acknowledged that the new laws may make sourcing actives difficult and said its plan will allow it to permit the importation of batches lacking the documents on a case-by-case basis if drugmakers can prove their sources will not be able to continue shipping from next month.
An MHRA spokesman told in-Pharmatechnologist.com that drug actives "will need to be accompanied by a written statement, or come from a country listed by the Commission, or have a valid EU GMP certificate. If this is not the case, then we can, at the request of the finished product manufacturer, provide an opinion on whether the ASs can be imported and used in the manufacture of the finished dose product."
He added that: "We discussed our contingency plans with the pharmaceutical industry and they are very supportive and have been lobbying other Member States to adopt a similar approach."
Drugmakers seeking such dispensation will need to have audited the active pharmaceutical ingredient (API) manufacturing site in question in the past three years and found it to be in compliance with EU good manufacturing practices (GMP).
The manufacturing site will also need a certificate of GMP compliance issued by a recognised national authority or an international organisation the US-FDA, EU-MRA partners, EU-ACCA partners, PIC/S member states and the WHO.
Data from audited API sites that lack documentation from regulators will be stored in a database and will be reviewed when during routine re-inspection of the UK finished product manufacturing site.
The agency said that: “The aim of these contingency plans is to ensure, as per the aims of the Falsified Medicines Directive, the continued supply of ASs [active substances] 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.”
The MHRA also stressed that the new import laws are subject of an ongoing review at EU level and reiterated the UK and European drugmakers have a key role to play in ensuring the regulations work.
“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.”
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