Principles and Practice of Pharmaceutical Medicine

List of competent authorities to which the appli-
cation was submitted, and their decisions

The supporting documentation, submitted only to
the RA, comprises

IMP dossier or simplified IMP dossier for known
products

SmPC*

Ethics committee approval*

Outline of all active trials with the same IMP

IMP manufactured in EU: copy of manufacturer
authorization

IMP not manufactured in EU: QP statement that
site complies with EU GMP (or at least equiva-
lent to EU GMP)

IMP not manufactured in EU: copy of importer
authorization

Certificate of analysis for test product where
impurities are not justified by the specification*

Examples of IMP label

Viral safety studies

Authorization for GMO, radiopharmaceuticals
(in the United Kingdom: ARSAC approval)*

Transmissible Spongiform Encephalopathy
(TSE) certificate*

Declaration of GMP status of active biological
substance

Manufacturing licence (on request)

Authorization for contract research organization
to represent sponsor*

Documents which need to be submitted to the

ethics committee only are the following:

Informed consent form

Subject information

Recruitment procedures, including advertise-

ments and so on, and informed consent

All information to be provided to the subject, for

example questionnaires, diaries and so on

Peer review of trial*

Ethical assessment made by the principal inves-

tigator

Suitability of site and adequacy of facilities

Suitability of investigator and key staff; CVs;

name and address of investigator; information

on key staff

Funding and possible conflicts of interest

Compensation statement

Sponsor indemnity

Investigator’s insurance

Payment to subjects

Agreement between sponsor and investigator

Publication policy and investigator’s access to

data, if not in protocol

After receipt of the application, the submission

is first validated, and then the review clock starts.

The review clock stops when a query is raised, and

begins again with the sponsor’s response. The pro-

cedure will end with an affirmative decision

(one way or the other). Sponsorscannot, however,

if applicable and/or available if applicable and/or available

34.6 CURRENT EUROPEAN REGULATORY PRACTICE 451