Pharmacovigilance by Ronald D Mann; Elizabeth B Andrews

By Ronald D Mann; Elizabeth B Andrews

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This system shall also take into account any available information on misuse and abuse of medicinal products which may have an impact on the evaluation of their benefits and risks. THE AGENCY Article 105 requires the Agency, in collaboration with the Member States and the Commission, to set up a data-processing network to facilitate the exchange of pharmacovigilance information in order to enable all the competent authorities to share pharmacovigilance information at the same time. The development of the EudraNet facility is discussed further below.

Rather, these products must keep adverse reactions records and make those available to the FDA upon request. R. 170(a). With regard to a ‘‘complication of blood collection or transfusion’’ that is fatal, this information must be communicated to the FDA as soon as possible, followed by a written report within seven days. R. 170(b). R. 80 as set forth below. In addition, certain childhood vaccines are also regulated by the National Childhood Vaccine Injury Act of 1986 (NCVIA) (Section 2125 of the PHSA).

MEMBER STATES Article 20 requires the competent authorities of Member States to ensure that all relevant informa- tion about suspected adverse reactions to centrally authorised products are brought to the attention of the Agency. Where the suspected adverse reactions are classified as serious, Article 23 requires the competent authorities to record and report them to the Agency and the marketing authorisation holder within 15 days. The Agency is then responsible for informing the competent authorities of the other Member States.

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