- Docket Number:
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Guidance Issuing OfficeCenter for Veterinary Medicine
The objective of this guidance is to provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products.
The need to transfer and disseminate information quickly, accurately and easily between Regulatory Authorities (RA) and Marketing Authorization Holders (MAH) on a worldwide scope is especially pertinent to the notification and assimilation of information for pharmacovigilance. Whereas the recommended definition of the pharmacovigilance information has been set forth within GL42, this GL35 guidance defines the recommended electronic standards for transfer of data.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2011-D-0588.