EU: further Extension of GMP and GDP Certificates

Back in April 2020, the European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMAs) and the European Commission announced that due to pandemic-related safety measures and travel restrictions and the associated limitations on inspections, expiring GMP and GDP certificates and temporary manufacturing, import and wholesale authorisations would be extended until the end of 2021. This deadline is now expiring, but many of the restrictions remain in place, even though inspection activities have partly been resumed. Therefore, the corresponding validity periods will now be extended again.

For this purpose, the "Notice to Stakeholders: Questions and answers on Regulatory Expectations for Medicinal Products for Human Use during the Covid-19 Pandemic" has been re-versioned. (now in Revision 4).

For sites in and outside the EU and the European Economic Area (EEA), the certificates are automatically extended until the end of 2022. However, there are exceptions:

• restrictions on the validity period are stated in the clarifying remarks of the GMP certificate
• changes in the scope of the GMP certificate (e.g. new buildings, new medicinal products).

What about new sites without a certificate?

For new sites in the EU/EEA, a distant assessment can be carried out to assess whether the site can be approved without an on-site inspection. Outside the EU/EEA, a distant assessment by an EEA regulator may equally be required if there is no applicable Mutual Recognition Agreement (MRA) with local regulators. In such cases, it shall be stated that the certificate was issued on the basis of a distant assessment. An on-site inspection is to be carried out as soon as circumstances allow.

The document stresses that the obligation of manufacturers and importers to comply with GMP is not waived. Inspections (including distant assessments) can be initiated at any time and appropriate regulatory action will be taken in case of non-compliance.