Principles and Practice of Pharmaceutical Medicine

Most companies elect to prepare six-monthly
reports and when the reporting intervals to the
RA prolong, to submit a number of reports together
with a brief bridging report. Please note that data
are always only presented for the reporting period
and not cumulatively since launch of a product.
The timing of the PSUR is governed by its
international birth date: the date of first launch of
the product.

Individual case safety reports (ICSR)

The bases for all expedited, but also cumulative or
periodic reports are individual case reports. The
accepted reporting format for individual case
reports is the Council of International Organiza-
tions of Medical Sciences (CIOMS) form. How-
ever, all other forms are acceptable in principle, as
long as they contain the necessary information.
Cases must fulfill minimum requirements to qua-
lify for reporting: a reporter, an event, a drug and a
patient must be identifiable. In the EU, the reporter
can only be a healthcare professional, unlike in the
United States, where the Food and Drug Adminis-
tration (FDA) accepts reports from consumers.
All European RAs have access to the Eudravigi-
lance database. (EudraV) Electronic transmission of
ICSRs in to the EMEA has been made mandatory
since 2004, electronic reporting to national autho-
rities and electronic receipt of case reports from any
authority are mandatory since November 20, 2005.
RAs and pharmaceutical companies alike prepare to
set up electronic gateways to exchange safety infor-
mation and compile it in Eudravigilance. Until all
competent authorities are fully capable of electronic
data exchange, ICSRs can be submitted as hard-
copies (have access to the EudraV).

34.15 Regulation of advertising

and promotion

Advertising and promotion are again covered in
detail elsewhere in this book. Here we shall just
briefly discuss some of the European regulatory
aspects.

Directive 2001/83 sets the framework for the

regulation of promotion and advertising in the

EU. The European Federation of Pharmaceutical

Industries’ Associations (EFPIA) has produced the

European Code of Practice for the promotion of

medicines and requires each MS to establish a

committee to deal with complaints. This commit-

tee must include independent members. Despite

the Directive and the European Code, the regula-

tion of promotion and advertising of medicinal

products is still not harmonized throughout the

EU. Every MS can make individual additions to

the code and, as always, the Directive gives only

general guidance with room for individual inter-

pretation.

Voluntary codes of practice have been in use in

many MS for many years. For example, in the

United Kingdom, theABPI Code of Practiceis

applicable to prescription medicines, and the Pro-

prietary Association of Great Britain (PAGB)

‘Code of Standards of Advertising Practice’ for

over-the-counter medicines.

The general principles of advertising and pro-

motion are the following:

It is an offence to issue a false or misleading

advertisement or representation about a medic-

inal product; in particular, the advertisement has

to comply with the approved SmPC.

The product must be presented objectively and

without exaggeration, to encourage its rational

use.

It is an offence to issue an advertisement about a

non-authorized indication, and no promotion of

a medicinal product is permitted before it is

granted MA.

The advertising of POMs to the consumer (the

patient) and thus the general public is prohibited.

In the United Kingdom, copies of all advertise-

ments must be submitted to the RA every

12 months. Furthermore, it is a requirement that

the approved SmPC is supplied within 15 months of

an advertisement. Meanwhile the British pharma-

ceutical industryprovides a compendium ofSmPCs

34.15 REGULATION OF ADVERTISING AND PROMOTION 481