CHAPTER II

Minimum requirements for the quality systems for the performance of pharmacovigilance activities
Section 2

Minimum requirements for the quality systems for the performance of pharmacovigilance activities by marketing authorisation holders

Management of human resources
Article 10
1
The marketing authorisation holder shall have sufficient competent and appropriately qualified and trained personnel available for the performance of pharmacovigilance activities.
For the purposes of the first subparagraph, the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has acquired adequate theoretical and practical knowledge for the performance of pharmacovigilance activities. Where the qualified person has not completed basic medical training in accordance with Article 24 of Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications , the market authorisation holder shall ensure that the qualified person responsible for pharmacovigilance is assisted by a medically trained person. This assistance shall be duly documented.
2
The duties of the managerial and supervisory staff, including the qualified person responsible for pharmacovigilance, shall be defined in job descriptions. Their hierarchical relationships shall be defined in an organisational chart. The marketing authorisation holder shall ensure that the qualified person responsible for pharmacovigilance has sufficient authority to influence the performance of the quality system and the pharmacovigilance activities of the marketing authorisation holder.
3
All personnel involved in the performance of pharmacovigilance activities shall receive initial and continued training in relation to their role and responsibilities. The marketing authorisation holder shall keep training plans and records for documenting, maintaining and developing the competences of personnel and make them available for audit or inspection.
4
The marketing authorisation holder shall provide appropriate instructions on the processes to be used in case of urgency, including business continuity.

Compliance management
Article 11
1
Specific quality system procedures and processes shall be in place in order to ensure the following:
a
the continuous monitoring of pharmacovigilance data, the examination of options for risk minimisation and prevention and appropriate measures are taken by the marketing authorisation holder;
b
the scientific evaluation by the marketing authorisation holder of all information on the risks of medicinal products, as referred to in the second subparagraph of Article 101(1) of Directive 2001/83/EC;
c
the submission of accurate and verifiable data on serious and non-serious adverse reactions to the Eudravigilance database within the time limits provided for in the first and second subparagraphs respectively of Article 107(3) of Directive 2001/83/EC;
d
the quality, integrity and completeness of the information submitted on the risks of medicinal products, including processes to avoid duplicate submissions and to validate signals in accordance with Article 21(2);
e
effective communication by the marketing authorisation holder with the national competent authorities and the Agency, including communication on new risks or changed risks, the pharmacovigilance system master file, risk management systems, risk minimisation measures, periodic safety update reports, corrective and preventive actions, and post-authorisation studies;
f
the update of product information by the marketing authorisation holder in the light of scientific knowledge, including the assessments and recommendations made public via the European medicines web-portal, and on the basis of a continuous monitoring by the marketing authorisation holder of information published on the European medicines web-portal;
g
appropriate communication by the marketing authorisation holder of relevant safety information to healthcare professionals and patients.
2
Where a marketing authorisation holder has subcontracted some of its pharmacovigilance tasks, it shall retain responsibility for ensuring that an effective quality system is applied in relation to those tasks.

Record management and data retention
Article 12
1
Marketing authorisation holders shall record all pharmacovigilance information and ensure that it is handled and stored so as to allow for accurate reporting, interpretation and verification of that information.
Marketing authorisation holders shall put in place a record management system for all documents used for pharmacovigilance activities that ensures the retrievability of those documents as well as the traceability of the measures taken to investigate safety concerns, of the timelines for those investigations and of decisions on safety concerns, including their date and the decision-making process.
Marketing authorisation holders shall establish mechanisms enabling the traceability and follow-up of adverse reaction reports.
2
Marketing authorisation holders shall arrange for the elements referred to in Article 2 to be kept for at least five years after the system as described in the pharmacovigilance system master file has been formally terminated by the marketing authorisation holder.
Pharmacovigilance data and documents relating to individual authorised medicinal products shall be retained as long as the product is authorised and for at least 10 years after the marketing authorisation has ceased to exist. However, the documents shall be retained for a longer period where Union law or national law so requires.

Audit
Article 13
1
Risk-based audits of the quality system shall be performed at regular intervals to ensure that the quality system complies with the quality system requirements set out in Articles 8, 10, 11 and 12 and to determine its effectiveness. Those audits shall be conducted by individuals who have no direct involvement in or responsibility for the matters or processes being audited.
2
Corrective action(s), including a follow-up audit of deficiencies, shall be taken where necessary. A report on the results of the audit shall be drawn up for each audit and follow-up audit. The audit report shall be sent to the management responsible for the matters audited. The dates and results of audits and follow-up audits shall be documented in accordance with the second subparagraph of Article 104(2) of Directive 2001/83/EC.
OJ L 255, 30.9.2005, p. 22.