Directive 2001/83/EC of the European Parliament and of the CouncilShow full title

[F1 CHAPTER 5 U.K. Implementation, Delegation and Guidance

Article 108 U.K.

In order to harmonise the performance of the pharmacovigilance activities provided for in this Directive, the Commission shall adopt implementing measures in the following areas for which pharmacovigilance activities are provided for in Article 8(3), and in Articles 101, 104, 104a, 107, 107a, 107b, 107h, 107n and 107p:

(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 national competent authorities and the marketing authorisation holder;

(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 in the Eudravigilance database to determine whether there are new risks or whether risks have changed;

(e)

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

(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 for 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 121(2).

Article 108a U.K.

In order to facilitate the performance of pharmacovigilance activities within the Union, the Agency shall, in cooperation with competent authorities and other interested parties, draw up:

(a)

guidance on good pharmacovigilance practices for both competent authorities and marketing authorisation holders;

(b)

scientific guidance on post-authorisation efficacy studies.

Article 108b U.K.

The Commission shall make public a report on the performance of pharmacovigilance tasks by the Member States on 21 July 2015 at the latest and then every 3 years thereafter.]

Textual Amendments

F1 Substituted by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use (Text with EEA relevance).