Directive 2010/84 - Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC on the EC code relating to medicinal products for human use - Main contents

EN

Official Journal of the European Union

L 348/74

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (5) lays down harmonised rules for the authorisation, supervision and pharmacovigilance of medicinal products for human use within the Union.

Pharmacovigilance rules are necessary for the protection of public health in order to prevent, detect and assess adverse reactions to medicinal products placed on the Union market, as the full safety profile of medicinal products can only be known after they have been placed on the market.

In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products.

While the fundamental objective of the regulation of medicinal products is to safeguard public health, this aim should nevertheless be achieved by means that do not impede the free movement of safe medicinal products within the Union. It has emerged from the assessment of the Union system of pharmacovigilance that divergent actions by Member States in relation to safety issues pertaining to medicinal products are creating obstacles to the free movement of medicinal products. In order to prevent or eliminate those obstacles the existing pharmacovigilance provisions at Union level should be strengthened and rationalised.

For the sake of clarity, the definition of the term ‘adverse reaction’ should be amended to ensure that it covers noxious and unintended effects resulting not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside the terms of the marketing authorisation, including the misuse and abuse of the medicinal product. The suspicion of an adverse drug reaction, meaning that there is at least a reasonable possibility of there being a causal relationship between a medicinal product and an adverse event, should be sufficient reason for reporting. Therefore, the term ‘suspected adverse reaction’ should be used when referring to reporting obligations. Without prejudice to the existing Union and national provisions and practices on medical confidentiality, Member States should ensure that reporting and processing of personal data related to suspected adverse reactions, including those associated with medication errors is carried out on a confidential basis. This should not affect Member States’ obligations regarding the mutual exchange of information on pharmacovigilance issues or their obligation to make available to the public important information on pharmacovigilance concerns. Furthermore, the principle of confidentiality should not affect the obligations of the persons concerned to provide information under...