The European Medicines Agency (EMA) announces to waive fees for on-site Good Manufacturing Practices (GMP) of drug makers and blood establishments that have undergone remote inspections during COVID-19 pandemic.
The fees will be waived fully for sites that undergo remote inspections where GMP compliance cannot be confirmed and the inspection must be rescheduled “due to the limitations of a distant assessment.
The policy entered into force on 12 May and will remain in place “during the period where access to sites for inspections were restricted due to COVID-19.”
Key Articles of the EMA Fee Waiver:
The manufacturing of medicinal products must be complaint with the provisions of Good Manufacturing practices (GMP) and the EMA has decided on the following Articles:
Scope of the initiative:
- Reduced fee levels shall be introduced for GMP on-site inspections, in cases where a distant assessment had been conducted for the said site during the period where access to sites for inspections were restricted due to COVID-19 pandemic, but where based on this distant assessment GMP compliance could not be confirmed due to the limitations of a distant assessment, consequently no GMP certificate could be issued, and thus a subsequent on-site inspection is required to confirm compliance.
- Plasma Master Files inspections are also in the scope of this initiative and will follow the same principle, if applicable.
- The applicable fee for the on-site inspection in accordance of Article 1 above shall be reduced by 100%.
Remuneration of national competent authorities (inspectorates):
- During the initiative, the remuneration to national competent authorities shall not be reduced, if the national competent authority provides a comprehensive inspection report for the distant assessment and a subsequent independent report for the on-site inspection.
Processing of fee reductions:
- During the initiative, any request for inspection covered by this decision will be assigned the applicable reduced fee. No separate request for fee reduction by the applicant or Marketing Authorization Holder is required during this period.
This decision is made after understanding the regulatory expectations amid pandemic that allows distant assessment by national competent authorities. The marketing authorization holders will automatically have the fee waived for qualifying inspections and that no separate fee waiver request is necessary.
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