Article 15: Compliance management
1. The national competent authorities and the Agency shall establish specific procedures and processes in order to achieve all of the following objectives:
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(a) |
ensuring the evaluation of the quality, including completeness, of pharmacovigilance data submitted; |
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(b) |
ensuring the assessment of pharmacovigilance data and its processing within the timelines provided by Directive 2001/83/EC and Regulation (EC) No 726/2004; |
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(c) |
ensuring independence in the performance of pharmacovigilance activities; |
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(d) |
ensuring effective communication among national competent authorities and between the national competent authorities and the Agency as well as with patients, healthcare professionals, marketing authorisation holders and the general public; |
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(e) |
guaranteeing that the national competent authorities and the Agency inform each other and the Commission of their intention to make announcements relating to the safety of a medicinal product authorised in several Member States or an active substance contained in such a medicinal product in accordance with Article 106a of Directive 2001/83/EC; |
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(f) |
conducting inspections, including pre-authorisation inspections. |
2. In addition to the procedures referred to in paragraph 1, national competent authorities shall establish procedures for collecting and recording all suspected adverse reactions that occur in their territory.
3. The Agency shall establish procedures for the monitoring of medical literature in accordance with Article 27 of Regulation (EC) No 726/2004.