Appendix 1: Information required for
UK applications to the
MHRA
Information for competent authorities1
Core information
- Receipt of confirmation of EUDRACT number
(obtained from the EUDRACT database)
- Covering letter
- Application Form
- Protocol with all current amendments
- Investigator's brochure
- Investigational Medicinal Product Dossier
(IMPD)
- Simplified IMPD for known products
- Summary of Product Characteristics (SmPC) (for
products with marketing authorisation in the Community)
- List of Competent Authorities to which the application has
been submitted and details of decisions
- Copy of ethics committee opinion when available
MS specific information
Protocol related
- Summary of the protocol in the national language
- Outline of all active trials with the same IMP
IMP
related
If IMP manufactured in
EU:
- Copy of the manufacturer authorization referred to in Art.
13.1. of the Directive stating the scope of this
authorization
If IMP not manufactured in
EU:
- Declaration of the QP that the manufacturing
site works in compliance with
GMP at
least equivalent to EU GMP
(see A)
- Copy of the importer authorization as referred to in Art. 13.1.
of the Directive
Certificate of analysis for test product in exceptional cases
- Summary of the protocol in the national language
- Certificate of analysis for test product where impurities are
not justified by the specification (see
A)
- Viral safety studies
- Examples of the label in the national language
- Applicable authorisations to cover trials or products with
special characteristics (if available) e.g. GMOs,
radiopharmaceuticals
- TSE Certificate when applicable
- Declaration of GMP status of active biological
substance
- Manufacturing license when applicable (see
B)
A. If not available
at the time of submission of the application, should be provided before
the study begins
B. On request