This guidance shall be published in Volume 9 of The rules .. ANNEX I – VEDDRA list of Clinical Terms (EMEA/CVMP/ /Final). in consultation with the European Medicines Agency (EMEA – “the Agency”) Structure of Volume 9A Part I deals with Guidelines for. Flag of European Union portal · Other countries · Atlas · v · t · e. EudraLex is the collection of rules and regulations governing medicinal products in the European Union. Contents. 1 Volumes; 2 Directives; 3 See also; 4 References; 5 External links. Volumes[edit]. EudraLex consists of 10 volumes: Volume 9 – Pharmacovigilance.

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Eudralex – Pharmacovigilance for Medical Products Volume 9a

Supporting Documentation Supporting documentation can be added to the DDPS, confirming that the PV system is in correct working order and, volumd relevant, providing information about changes or revisions to the system. There is no structure prescribed for the recording system, although data protection regulations must be complied with when handling patients’ personal details.

Detailed Description of the Pharmacovigilance System The DDPS contains the company-wide definition, independent of products and licences, of the working structures and processes established in the company for ensuring the safety of the medicinal product. At the same time, there are synergy effects in terms of cost structures. The Marketing Authorisation Holder is responsible for the safety of its products and must emew to commission emes Qualified Person volumme Pharmacovigilance QPPV to monitor the safety of medicinal products and to provide this person with the requisite resources to do so.

Cooperation with service providers, in turn, places special requirements on the PV system operated by the pharmaceutical company. It should be noted that there is no fundamental difference between a contractual commitment to a service provider and being committed to changing employees through employment contracts.


A flow chart should be generated for the DDPS, showing the central processing steps within the company for an incoming report of a suspected adverse drug reaction cf. Quality Management System A brief description of the quality management system should also be submitted.

How is compliance with the timescale regulated?

Eudralex – Pharmacovigilance for Medical Products Volume 9a

This additional information may be particularly important for assessments or inspections. Experienced service providers can provide these companies with assistance in implementing a PV system which meets requirements, including documentation.

The SOPs should generally be made available within two days, on request from the competent authority. Administrative information application volhme Eudralex Volume 2B Module 1: It is imperative that tasks and interfaces are clearly voulme. There should also be a diagram organisation chart depicting the structure of the organisation in order to illustrate the general outline within the company and in relation to external partners.

Service providers can take receipt of spontaneous reports. In addition to the structure of the database and data back-up, attention must also be paid to standards for reporting adverse drug reactions, EudraVigilance registration, updating and validation. Records must be kept of the initial and further training of the personnel who are assigned PV activities.

The services they offer are being continuously refined. However, formal responsibility for the safety of the medicinal products remains with the pharmaceutical company. The DDPS also contains a description of the organisational structure. Product-specific additions, such as the exchange of safety-related data with a licensing partner, should be illustrated in an emeq.

It is recommended that the Marketing Authorisation Holder conduct audits. A competent regional authority may also participate in the inspection.

Designing Efficient Pharmacovigilance Systems

External service providers and consultants may be involved in virtually any pharmacovigilance process. Where relevant, the Marketing Authorisation Holder must provide a detailed description of the following components of its PV system cf. In the case of small and medium-sized businesses with a smaller number of approvals in particular, it makes sense, given the high cost burden involved, not to set up a separate department just to prepare PSURs which have to be compiled every 6, 12 or 36 months.


Therefore, the relevant SOP has to show which information minimum criteria is to be recorded, how it is to be recorded e. Therefore, routine audits are advisable. Documentation The PV system, of course, also includes storage of the compiled documents.

Volume 9A outlines certain requirements on the basis of which inspections volumw conducted. All the people who receive training should provide written confirmation that they have been trained.

Guidelines Regulations – GMP Navigator

Specialised service providers can often respond to changes in the law more quickly, offering suitably adapted solutions soon afterwards. The possible disadvantages identified in outsourcing are a potential dependence on external third parties or upon the reliability of their work.

Service providers may handle spontaneous reports instead of the Marketing Authorisation Holder. However, spontaneous reports are frequently received directly by the company, a contracted call centre or via another source.

At the same time, the EudraLex Volume 9A empowers the competent federal authority to conduct pharmacovigilance inspections in order to check the practice and content of the implemented system on site. A brief description of the quality management system should also be submitted.

The QPPV must, for instance, maintain an overview of safety profiles and precautions for the medicinal products or implement them in the first instance.