Legal Basis – EU

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Chapter: Pharmacovigilance: Legal Basis – EU

Within the European Union (EU), the pharmaceutical industry is a highly regulated sector.

Legal Basis – EU


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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