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European Medicines Agency (EMA)
Article 87a

Article 87a

In order to harmonise the performance of the pharmacovigilance activities provided for in this Regulation, the Commission shall adopt implementing measures as provided for in Article 108 of Directive 2001/83/EC covering the following areas:

(a)

the content and maintenance of the pharmacovigilance system master file kept by the marketing authorisation holder;

(b)

the minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency;

(c)

the use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities;

(d)

the minimum requirements for the monitoring of data included in the Eudravigilance database to determine whether there are new risks or whether risks have changed;

(e)

the format and content of electronic transmission of suspected adverse reactions by Member States and marketing authorisation holders;

(f)

the format and content of electronic periodic safety update reports and risk management plans;

(g)

the format of protocols, abstracts and final study reports of the post-authorisation safety studies.

Those measures shall take account of the work on international harmonisation carried out in the area of pharmacovigilance and shall, where necessary, be revised to take account of technical and scientific progress. Those measures shall be adopted in accordance with the regulatory procedure referred to in Article 87(2).

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