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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In that case, however, the DDPS or the accompanying SOPs should contain notes explaining the procedures for the systematic processing and documentation of adverse drug reactions and how they are smea. Product-specific additions, such as the exchange of safety-related data with a licensing partner, should be illustrated in an appendix.

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 Emwa on setting health based exposure limits for use in voluume identification in the manufacture of different medicinal products in shared facilities Eudralex Volume 4 – Medicinal Products for Human and Veterinary Use: Where relevant, the Marketing Authorisation Holder must provide a detailed description of the following components of its PV system cf.

An inspector from the regulatory authority or a commissioned external auditor should be able to refer to this organisational description and identify potential gaps or needless procedures in the PV processes.

Volums use is being made of this option.

At the same time, there are synergy effects in terms of cost structures. The external contracting partner must implement quality assurance and quality controls.

Does the service provider also undertake the research of literature? Clinical Safety Data Management: The purpose voume the Detailed Description of emez Pharmacovigilance System DDPS which is formalised in Volume 9A is to describe ema actual safety-monitoring practice followed in the company. The EudraLex Volume 9A incorporated the obligation to include a “Detailed Description of the Pharmacovigilance System” in every marketing authorisation application module 1.


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. The synergy potential stems from the harmonisation of the birth dates for what are now well over 1, active ingredients at national and European level.

He or she is, among other things, responsible for submitting reports of adverse drug reactions and PSURs, for periodic research through literature, for personnel training and acts as the central contact for the authorities. Detailed Description of the Pharmacovigilance System The DDPS contains the company-wide definition, independent of products and licences, of emeaa working structures and processes established in the company for ensuring the safety of the medicinal product.

Eudralex – Pharmacovigilance for Medical Products Volume 9a

This comprises, among other things, the areas of recording, processing and reporting suspected incidents of adverse drug reactions ADRs of medicinal products, compiling and reviewing Periodic Safety Update Reports PSURssignal detection, as well as emergency procedures within the company. In short, the QPPV is responsible for ensuring that the PV system in the company conforms to current statutory regulations and is practised in full. As in other situations where tasks are outsourced, the Marketing Authorisation Holder takes on a certain dependence: External service providers and consultants may be involved in virtually any pharmacovigilance process.

It is important to remember, for example, that even where medicinal products are only approved nationally for example in Germany, suspected serious and unexpected adverse drug reactions experienced in non-EU member states still have to be reported electronically to the EMEA’s EudraVigilance database by specially trained personnel.

At the same time, if suspected adverse drug reactions are encoded and evaluated by an independent third party, the utmost objectivity and commercial independence are guaranteed. Where necessary, this may also be contracted out to PV service providers. 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. Experienced service providers can provide these companies with assistance in implementing a PV system which meets requirements, including documentation.


The pharmaceutical company will be given an opportunity to demonstrate its PV system during any inspection, which generally takes one or few day s. The possible disadvantages identified in outsourcing are a potential dependence on external third parties or upon the reliability of their work.

Alternatively, traditional paper-based recording can also be used in businesses which experience few reports of adverse drug reactions. EudraLex Volume 9A requires Marketing Authorisation Holders to invest considerable manpower and financial resources in monitoring the safety of pharmaceutical products. All employees, from the switchboard to the field service to the Drug Safety department, should have a sound understanding of the company’s standard procedures for taking receipt of PV-related information.

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

Eudralex – Pharmacovigilance for Medical Products Volume 9a

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. Safety, environment and information: 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. Furthermore, the inspectors shall examine individual elements, such as the recording, processing and quality of incident reports, the data-acquisition system or the job descriptions of employees who are involved in the creation emex PV documents.

Some companies outsource all their PV tasks so as to ensure that they instantly have a fully functioning PV system. This includes “more detailed information for example about the product range, the SOPs, about further training documentation or further facilities.