Emea 410 01 current edition

BIO welcomes the revision of this note for guidance in line with industry and agency experience gained since the issuance of the previous note for guidance on Transmissible Spongiform Encephalopathy. In general, the revisions are welcome. However, BIO members have concerns regarding the alignment of Revision 4 with other requirements.

If the certificates do not remain valid, product withdrawal may occur and may interrupt product availability to patients. This confirmation process will take time to be accomplished. In turn, we suggest that the marketing authorization holders referencing the certificates be required to submit a variation within 90 days of the re-issued EDQM TSE Certificates of Suitability.

Human regulatory Overview Research and development Marketing authorisation Post-authorisation Herbal products. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation. Minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. When applicable, read together with explanatory note for medicinal products for human use on the scope of the guideline and explanatory note on the gelatin for use in pharmaceuticals.

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