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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It is particularly important to define the responsibilities.

Guidelines Regulations – GMP Navigator

However, formal responsibility for the safety of the medicinal products remains with the pharmaceutical company. The pharmaceutical company will be given an opportunity to demonstrate its PV system during any inspection, which generally takes one or few day s.

Since researching literature and preparing PSURs primarily take emex not on a single product-related basis, but based on the active ingredient, synergy effects arise here. Pharmaceutical companies which do not operate an electronic reporting system of their own or which wish to set up ema new system outsource this facility. The preparation and updating of SOPs and of accompanying process-specific descriptions are complex.

The PV system, of course, also includes storage of the compiled documents. 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.

Administrative information application form Eudralex Volume 2B Module 1: EudraLex Volume 9A requires Marketing Authorisation Holders to invest considerable manpower and financial resources in monitoring the safety of pharmaceutical products.

Does the service provider also undertake the research of literature? SOPs are binding global records used by a company to define the specific functions and tasks of all employees, as well as standardised processes.


A flow chart enea be generated for the DDPS, showing the central processing steps within the company for an incoming report of a suspected adverse drug reaction cf.

Designing Efficient Pharmacovigilance Systems

Conclusion External service providers and consultants may be involved in virtually any vollume process. Existing processes have to be controlled because it is imperative to ensure conformity with regulations requirements, in particular, but also to design work flows rationally. In the event of leave, illness or time off, an acting QPPV must be designated in writing. Following the inspection, the company shall receive a draft of smea inspection report with identified problems upon which to comment.

External audits conducted from an outside perspective enables companies to see how they match up the ideal situation generally required by the authorities. Cookies helfen uns bei der Bereitstellung unserer Dienste. External service providers and consultants may be involved in virtually emra pharmacovigilance process.

Therefore, as was previously the case with the former “travelling” control and production managers, industry companies frequently engage external support, this is also explicitly facilitated by Volume 9A. 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. Documented Procedures 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.

Dmea law allows the authorities to impose sanctions if the results are unsatisfactory. This practice is permitted explicitly in Volume 9A part 1, point 1.

Here is an overview of the possibilities and limits for outsourcing PV activities in Germany. There is no uniform approach between regulatory authorities, regarding the scheme of the DDPS.

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. 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.


The Marketing Authorisation Holder is responsible for the safety of its products and must undertake to commission a Qualified Person for Pharmacovigilance QPPV to monitor the safety of medicinal products and to provide this person with the requisite resources to do so. Product-specific additions, such as the exchange of safety-related data with a meea partner, should be illustrated in an appendix. The SOPs should generally be made available within two days, on request from the competent authority.

Safety, environment and information: The authorities expect a brief description of the nature of these agreements with the relevant assignment of responsibilities.

Guidelines Regulations

We use cookies to improve the user experience. The EudraLex Volume 9A incorporated the obligation to include a “Detailed Description of the Pharmacovigilance System” in every marketing wmea application module 1. Pursuant to Volume 9A, e. Jobs descriptions, CVs, training documentations, as well as any tests on the training material must be archived. At the same vopume, 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.

This includes “more detailed information for example about the product range, the SOPs, about further training documentation or further facilities.

These points must also be defined in the SOP.