QP Qualified person (for GMP)
RA Regulatory authority
REC Research ethics committee
RMS Reference member state
SAWG Scientific Advice Working Group
SmPC Summary of product characteristics
SUSAR Serious unexpected suspected adverse
drug reaction
TAG Therapeutic Advisory Group
TSE Transmissible Spongiform Encephalo-
pathy
USA United States of America
34.1 The European regulatory
frameworkThe Treaty of Rome (1957) created a single com-
munity out of several European countries with
diverse cultures and histories: Belgium, France,
Italy, Luxembourg, the Netherlands and (then)
West Germany. Among other things, this began a
process of harmonization of regulations and tech-
nical requirements for the marketing authorization
(MA) of medicines, within a European common
market. The United Kingdom, Denmark and Ire-
land joined in 1973, Greece in 1981, Spain and
Portugal in 1986 and Austria, Finland and Sweden
in 1995. On May 1, 2004, 10 more nations joined:
Cyprus, the Czech Republic, Estonia, Hungary,
Latvia, Lithuania, Malta, Poland, Slovakia and
Slovenia. While the European Union (EU) was
formalized by the treaty of Maastricht in 1992,
already by 1975, the fundamental directives con-
cerning medicines had been issued.
34.2 The European legislative
mechanismThe instruments of EU government are used to
bring about legal, technical and administrative
harmonization among member states (MS).
These instruments are variously termed directives,
regulations, decisions, opinions and recommenda-
tions, and guidelines in roughly descending order
of legal ‘power’.
Directives are issued by the European Commis-
sion and the Council, and are binding as to their
objectives and results. MS are obligated to trans-
pose Directives into national law, with prescribed
timelines for doing so. In the case of medicines
regulation, this happens not only in the 25 countries
of the EU but also, on a voluntary basis, in the
additional countries of the European economic
area (EEA) (Norway, Liechtenstein and Iceland)
and even, to some extent, in Switzerland.
Regulations are laws of immediate application
for all MS and overrule national law. Regulations
are typically issued by the many agencies of the
EU, and may be viewed as interpretations, or more
practical descriptions of how Directives are to be
implemented.
EU decisions are directed at and are binding
upon named addressees, and are not necessarily
applicable throughout the EU. Addressees can be
individual MS, particular economic sectors or even
single organizations.
Opinions and recommendations are not legally
binding, being designed to enunciate governmental
views and current thinking on particular topics.
Often, opinions and recommendations form the
basis for future decisions, regulations or even
directives.
Guidelines provide technical interpretations of
the law, and usually set out what is thought to be
acceptable to regulatory authorities (RAs), for
example the European Medicines Evaluation
Agency (EMEA). In the field of medicines regula-
tion, guidelines can be published by individual
scientific committees within an agency, for exam-
ple the Committee for Human Medicinal Products
(CHMP). Although guidelines are not legally bind-
ing, they do constitute an official reference or pre-
cedent. Any deviation from such guidelines must
usually then be explained with sound scientific
justification. Special types of guidelines, quite
unlike the practices of the United States, are
those relating to a formal request laid down by a
Directive or Regulation; these guidelines are pub-
lished by the European Commission and are legally
binding; a recent example is theNote for Guidance
on Transmissible Spongiform Encephalopathies,
and is restrictions on bovine components in phar-
maceutical products.444 CH34 MEDICINES REGULATION IN THE EUROPEAN UNION