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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As in other situations where tasks are outsourced, the Marketing Authorisation Holder takes on a certain dependence: National law allows the authorities to impose sanctions if the results are unsatisfactory.

Eudralex – Pharmacovigilance for Medical Products Volume 9a

The points to be disclosed in the DDPS also include contractual agreements with people or businesses relating to pharmacovigilance. Cooperation with service providers, in turn, places special requirements on the PV system operated by the pharmaceutical company.

Professional associations are also very active in this area. The preparation and updating of SOPs and of accompanying process-specific descriptions are complex. Where necessary, this may also be contracted out to PV service providers. The external contracting partner must implement quality assurance and quality controls. Here is an overview of the possibilities and limits for outsourcing PV activities in Germany. There is no period of time stipulated for document retention e. Preparing a PSUR is where external service providers come into their own.

Therefore, routine audits are advisable. Whether the decisive factor is having an opportunity to participate in PSUR compilation service projects for known active ingredients or whether keeping the workload in check is what matters, Marketing Authorisation Holders frequently contract out the preparation of PSURs to specialised service providers.

Paradoxically, this frequently affects those pharmaceutical companies which have a low-risk product portfolio and which, therefore, have had to contend less intensively with the problems, formal and otherwise, of pharmaceutical safety. Product-specific additions, such as the exchange of safety-related data with a licensing partner, should be illustrated in an appendix.

Special attention should be given to the quality assurance of the PV system, as well as to auditing external service providers. 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. Therefore, the SOP’s description of the interfaces between the sources and the processors of PV-related data is particularly important when service providers are engaged on multiple levels.


The pharmaceutical company will be given an opportunity to demonstrate its PV system during any inspection, which generally takes one or few day s.

SOPs are binding global records used by a company to define the specific functions and tasks of all employees, as well 9q standardised processes.

Eudralex – Pharmacovigilance for Medical Products Volume 9a

Specialised service providers can often respond to changes in the law more quickly, offering suitably adapted solutions soon afterwards. Anja op de Bekke Dr. If, for example, the receipt of spontaneous reports is contracted out to a call centre, the Marketing Authorisation Holder has to ensure that the personnel concerned receive training and perform audits to ensure that the call centre agents are trained in how to receive and pass on spontaneous reports.

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. Therefore, the relevant SOP has to show which information minimum criteria is to be recorded, how it is to be recorded e.

EudraLex – Wikipedia

Legal Requirements The EudraLex Volume 9A incorporated the obligation to include a “Detailed Description of the Pharmacovigilance System” in every marketing authorisation application module 1. Archive planning should be designed on a suitably long-term basis. At the same time, the EudraLex Volume 9A vooume the competent federal authority to conduct pharmacovigilance inspections a9 order to check the practice and content of the implemented system on site.

Service providers may handle spontaneous reports instead of the Marketing Authorisation Holder.

Designing Efficient Pharmacovigilance Systems

It is imperative that tasks and interfaces are clearly defined. Alternatively, traditional paper-based recording can also be used in businesses which experience few reports of adverse drug reactions. 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.


Volume 9A outlines certain requirements on the basis of which inspections are conducted. Experienced service providers can provide these companies with assistance in implementing a PV system which meets requirements, including documentation. 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.

Designing Efficient Pharmacovigilance Systems Dr. By continuing to use this website, you consent to the use of 9aa. Contracts with PV service providers, such as for the task of the QPPV, for electronic reporting, for maintaining databases, researching literature or preparing PSURs, also come under this. The DDPS also contains a description of the organisational structure. In view of the complexity of the requirements and the resulting manpower requirements, businesses with a smaller wmea of marketing authorisations are at 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.

About two months’ notice is generally given for a routine inspection. There is now a wide array of highly skilled services available 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.

A competent regional authority may also participate in the inspection. External service providers and consultants may be involved in virtually any pharmacovigilance process. Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities Question and answers on implementation of risk based prevention of cross contamination in production and Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities Eudralex Volume 4 – Medicinal Products for Human and Veterinary Use: