In order to avoid market shortage of medically essential products, the GMP certificate will be conditioned to permit continued manufacturing and QC testing of "critical" products in situations where it has been agreed by the national competent authority or EMA that there is no feasible alternative in the market concerned. The scope of the statement of non-compliance is, therefore, limited to medicinal products considered non-critical to public health.
Accordingly, the company would be able to manufacture and supply from the said facility certain medicinal products critical to public health. The impact of the same on the existing business will only be known once the company receives further communication from UKMHRA. The said facility contributes approximately £12 million from the UK and European Union markets to the consolidated annual revenues of the company.
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