Description
This guidance provides general standards which should be used to register with the Center for Veterinary Medicine (CVM or the Center) Electronic Submission System (ESS).
Scope & Applicability
Stakeholders
3User role responsible for managing GUDID account and LDE users; Role that creates LDE users; Responsible for management of the GUDID account
Assists FDA in communications with foreign establishments
Role requiring an authorization letter for registration; Makes submissions on behalf of a new firm
Regulatory Context
Attributes
2Required to apply a digital signature to any CVM ESS form
Technical specifications for ESG setup
Identified Hazards
Hazards
1Unintentional scrambling of submission during transmission
Related CFR Sections (3)
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR207.69§ 207.69 What are the requirements for an official contact and a United States agent?
(a) Official contact. Registrants subject to the registration requirements of this part must designate an official contact for each establishment. The official contact is responsible for:Read full regulation →
- 21CFR11.200§ 11.200 Electronic signature components and controls.
(a) Electronic signatures that are not based upon biometrics shall:Read full regulation →
Related Warning Letters (2)
- 2022-06-28
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Fagron Group B.V.
- 2020-05-05
CGMP/Dietary Supplement/Adulterated/Misbranded
Hawaii Pharm LLC
See Also (8)
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention: Guidance for Industry (Status: Final)
- Chapter 1 - General (Status: Final)
- Using Electronic Means to Distribute Certain Product Information: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)
- Guidance for Industry: Questions and Answers on Juice HACCP Regulation (2003) (Status: Final)
- Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition (Status: Final)
- Small Entity Compliance Guide: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)