Within the European Union (EU), the pharmaceutical industry is a highly regulated sector.
Legal Basis – EU
INTRODUCTION
Within
the European Union (EU), the pharmaceutical industry is a highly regulated
sector. The level of regu-lation reflects the potential hazards associated with
the use of medicinal products. Subject to a limited number of exceptions, all
medicinal products placed on the market within the EU must have a marketing
authorisation. The grant of a marketing authorisation signifies that a
medicinal product complies with the quality, safety and efficacy criteria set
out in European medicinal product regulatory law. In 2004, a review of European
pharmaceutical regulatory law took place, in what is referred to as the ‘EU
Pharma Review’, and new legislation was issued. It is this new legislation that
is discussed in this chapter.
Marketing
authorisations for products to be placed on the EU market are granted:
·
on a national basis by the competent authority of a Member
State (where the product will be marketed in one Member State only); or
·
through the mutual recognition procedure, where a marketing
authorisation granted by the compe-tent authority of an original (‘Reference’)
Member State is accepted by the competent authorities of other Member States;
and
·
on an EU basis by the European Commission (the Commission)
under the centralised procedure, in accordance with the provisions of
Regulation (EC) No. 726/2004
Pharmacovigilance
requirements apply to all autho-rised medicinal products on the market in the
EU and European Economic Area (EEA) states (Iceland, Liechtenstein and Norway).
Both human use and veterinary medicinal products are subject to these
requirements; this chapter outlines the requirements for human use medicinal
products only.
The
need for pharmacovigilance arises from the fact that, despite extensive
clinical trials at the pre-licensing stage in support of a marketing
autho-risation application for a medicinal product, some safety hazards are
only identified after wider use in the general population. The aim of
establishing pharmacovigilance systems is to safeguard public health by taking
measures for the intensive super-vision of undesirable effects of authorised
medici-nal products so as to ensure the rapid withdrawal from the market of any
medicinal product present-ing a negative risk–benefit balance under normal
conditions of use.
The
key legal requirements for pharmacovigilance for human use medicinal products
are set out in European legislation. For medicinal products autho-rised under
national or mutual recognition procedures, the relevant legislation is
Directive 2001/83/EC of 6 November 2001 on the Community Code relating to
medicinal products for human use, as amended by Directive 2002/98/EC of 27
January 2003, Directive 2003/63/EC of 25 June 2003, Directive 2004/24/EC of 31
March 2004 and Directive 2004/27/EC of 31 March 2004. All references throughout
this chapter to Directive 2001/83/EC are to the amended text. For medicinal
products authorised under the centralised procedure, the relevant legislation
is Regulation (EC) No. 726/2004 laying down Community procedures for the authorisation
and supervision of medicinal products for human and veterinary use and
establish-ing a European Medicines Agency (the ‘Agency’). For investigational
medicinal products used in clin-ical trials, pharmacovigilance requirements are
set out in the Clinical Trials Directive, Directive 2001/20/EC.
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