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 case of external database solutions, the allocation of responsibilities between the company and the IT service provider must be clearly defined in the description of the PV system. 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.

The purpose of the Detailed Description of the Pharmacovigilance System DDPS which is formalised in Volume 9A is to describe the actual safety-monitoring practice followed in the company. Here is an overview of the possibilities and limits for outsourcing PV activities in Germany.

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. Documentation The PV system, of course, also includes storage of the compiled documents. This includes “more detailed information for example about the product range, the SOPs, about further training documentation or further facilities. In view of the complexity of the requirements and the resulting manpower requirements, businesses with a smaller number 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.

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.

About two months’ notice is generally given for a routine inspection. Pursuant to Volume 9A, e. Nevertheless, the law requires small and medium-sized businesses with OTC products to meet the same standard as that which applies to large corporations in the Rx sector.

Designing Efficient Pharmacovigilance Systems

In this regard, volmue also represents an dmea and consistent response by the pharmaceutical industry to the continuous pressure exterted by international regulations on safety issues.

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. 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.

Audits by internal or by experienced external auditors are helpful in preparing for official PV inspections.


Eudralex – Pharmacovigilance for Medical Products Volume 9a

At the same time, the law also permits companies to avail of the services of external service providers for pharmacovigilance PV. Service providers may handle spontaneous reports instead of the Marketing Authorisation Holder.

At the same time, there are synergy effects in terms of cost structures. Archive planning should be designed on a suitably long-term basis. 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.

Contractual Arrangements The points to be disclosed in the DDPS also include contractual agreements with people or businesses relating to pharmacovigilance. 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.

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.

At any rate, the advantage of outsourcing is continued quality assurance by engaging the services of highly specialised, experienced PV teams. 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.

EudraLex – Wikipedia

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. Designing Efficient Pharmacovigilance Systems Dr. The SOPs should generally be made available within two days, on request from the competent authority.

Cookies helfen uns bei der Bereitstellung unserer Dienste. 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.

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 emes PV processes.

There is no uniform approach between regulatory authorities, regarding the scheme of volune DDPS. Safety, environment and information: The DDPS should show where and how this is done, and, if relevant, indicate the name and address of the service provider commissioned to do this. The DDPS also contains a description of the organisational structure. Experienced service providers can provide these companies with assistance in implementing a PV system which meets requirements, including documentation.

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. Therefore, routine audits are advisable. 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.


Application and Application Form Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the voluume CT-1 Eudralex Volume 10 Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial CT-1 Eudralex Eemea 10 Substantial Amendment Notification Volumee Eudralex Volume 10 Declaration of the end of trial form Eudralex Volume 10 Annex 1 revised: It should include names, locations and internal contact details of the parts of the company which are responsible for PV, as well as a brief description of the activities conducted there.

If there vopume errors in emmea DDPS or if it is not submitted at all, an approval application will be rejected for formal reasons. Increasing use is being made of this option.

Designing Efficient Pharmacovigilance Systems

Others only bring in service providers who perform special tasks to reduce peak loads or avail of external expertise to ensure compliance with changing legal requirements. There should also be a cross-reference to a training SOP, which is used as a basis for training all the employees in question on how to process spontaneous reports.

Product-specific additions, such as the exchange of safety-related data with a licensing partner, should be illustrated in an appendix. The EudraLex Volume 9A incorporated the obligation to include a “Detailed Description of the Pharmacovigilance System” in every marketing authorisation application module 1. The aim is to handle and store data in such a way that it cannot be lost or falsified and to enable changes to be traced audit trail.

SOPs are binding global records used by a company to define the specific functions and tasks of all employees, as well as standardised processes. The QPPV must, for instance, maintain an overview of safety profiles and precautions for the medicinal products or implement them in the first instance. Administrative information application form Eudralex Volume 2B Module 1: All the people who receive training should provide written confirmation that they have been trained.

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. 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.

It applies to all medicinal products intended for human use which are registered in the Member States of the EU, as well as in Iceland, Liechtenstein and Norway — irrespective of the approval procedure national, mutual recognition, decentral, central and irrespective of the current approval status.

These points must also be defined in the SOP.