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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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Therefore, pharmaceutical companies producing low-risk medicinal products are turning increasingly to specialised PV service providers.

Documentation The PV system, of course, also includes storage of the compiled documents. In this volumw, outsourcing also represents an effective and consistent response by the pharmaceutical industry to the continuous pressure exterted by international regulations on safety issues.

Some companies outsource all their PV tasks so as to ensure that they instantly have a fully functioning PV system.

EudraLex Volume 9A requires Marketing Authorisation Holders to invest considerable manpower and financial resources in monitoring the safety of pharmaceutical products. However, spontaneous reports are frequently received directly by the company, a contracted call centre or via another source. Preparing a PSUR is where external service providers come into their own. Special attention should be given to the quality assurance of the PV system, as well as to auditing external service providers.

Databases The pharmaceutical company should maintain a system, normally a validated database, for ensuring that any adverse drug reactions reported to the pharmaceutical company can be recorded, classified and, where necessary, retrieved worldwide. Product-specific additions, such as the exchange of safety-related data with a licensing partner, should be illustrated in an appendix.


Specialised service providers can often respond to changes in the law more quickly, offering suitably adapted solutions soon afterwards. However, formal responsibility for the safety of the medicinal products remains with the pharmaceutical company.

Emez is particularly volum to define the responsibilities.

In view of the complexity of the requirements and the resulting manpower requirements, businesses with a smaller number of marketing authorisations are voolume a disadvantage compared to their larger competitors when it comes to PV; the more marketing authorisations a company manages, the more experience it acquires, thus enhancing the quality and efficiency of its pharmacovigilance procedures. Quality Management System A brief description of the quality management system should also be submitted.

SOPs are binding global records used by a company to define the specific functions and tasks of all employees, as well as standardised processes. As a general rule, the company being audited must submit the DDPS and various additional documents to the authority no later than 14 days before the date of the audit.

Eudralex – Pharmacovigilance for Medical Products Volume 9a

Since researching literature and preparing PSURs primarily take place not on a single product-related basis, but based on the active ingredient, synergy effects arise here. The preparation and updating of SOPs and of accompanying process-specific descriptions are complex. The authorities expect a brief description of the nature of these agreements with the relevant assignment of responsibilities. However, where scope for improvement is discovered, this can rarely be incorporated at short notice into an existing system without causing some disruption to the smooth running of the system, ahead of official inspections.



EudraLex – Wikipedia

Conclusion External service providers and consultants may be involved in virtually any pharmacovigilance process.

Supporting Documentation Supporting documentation can be added to the DDPS, confirming that the PV system is in correct working order and, if relevant, providing information about changes or revisions to the system.

In any event, the costs of an inspection shall be borne by the pharmaceutical company. The DDPS also contains a description of the organisational structure.

There is no period of time stipulated for document retention e. Processing reports of suspected cases of adverse drug reactions is a central issue of any PV system.

Administrative information application form Eudralex Volume 2B Module 1: This includes “more detailed information for example about the product range, the SOPs, about further training documentation or further facilities. This, for example, may take the form of co-marketing contracts which include a contractual provision on reporting spontaneous incidents.

Designing Efficient Pharmacovigilance Systems

Designing Efficient Pharmacovigilance Systems Dr. These points must also be defined in the SOP. There is now a wide array of highly skilled services voluem on the market, including auditing, commissions to submit electronic reports of suspected adverse drug reactions to the EMEA, the provision of Qualified Persons for Pharmacovigilance and the implementation of complete PV systems.

Voolume courses Records must be kept of the initial and further training of the personnel who are assigned PV activities. Following the inspection, the company shall receive a draft of the inspection report with identified problems upon which to comment.