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.

Author: Kagagami Nikolrajas
Country: Martinique
Language: English (Spanish)
Genre: History
Published (Last): 2 May 2014
Pages: 451
PDF File Size: 6.3 Mb
ePub File Size: 10.4 Mb
ISBN: 596-5-23376-752-7
Downloads: 86267
Price: Free* [*Free Regsitration Required]
Uploader: Kagakus

Therefore, the relevant SOP has to show which information minimum criteria is to be recorded, how it is to be recorded e. At the same time, there are synergy effects in terms of cost structures.

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.

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. Increasing use is being made of this option. Administrative information application form Eudralex Volume 2B Module 1: Where necessary, this may also be contracted out to PV service providers.

The external contracting partner must implement quality assurance and quality controls. Following the inspection, the company shall receive a draft of the inspection report with identified problems upon which to comment. 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. 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 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. Archive planning should be designed on a suitably long-term basis. The preparation and updating of SOPs and of accompanying process-specific descriptions are complex. Training courses Records must be kept of the initial and further training of the personnel who are assigned PV activities. Special attention should be given to the quality assurance of the PV system, as well as to auditing external service providers.

The authorities expect a brief description of the nature of these agreements with the relevant assignment of responsibilities. Designing Efficient Pharmacovigilance Systems Dr.


Designing Efficient Pharmacovigilance Systems

The DDPS also contains a description of the organisational structure. If vollume are errors in the DDPS or if it is not submitted at all, an approval application will be rejected for formal reasons.

Preparing a PSUR is volue external service providers come into their own. This should serve to document the fact that future Marketing Authorisation Holders have an effective safety system for their medicinal products in place, or —if they have not already done so— are able to establish such a system.

Cookies helfen uns bei der Bereitstellung unserer Dienste. 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.

There is no period of time stipulated for document retention e. Close This website volumf cookies We use cookies to improve the user experience. It is important to remember, for example, that even where medicinal ekea 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.

The QPPV must, for instance, maintain an overview of safety volkme and precautions for the medicinal products or implement them in the first instance. 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.

Guidelines Regulations – GMP Navigator

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

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. Where relevant, the Marketing Authorisation Holder must provide a detailed description of the following components of its PV system cf.

Guidelines Regulations

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.


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.

However, where scope for improvement is discovered, this can rarely be incorporated at short notice into an existing vklume without causing some volum to the smooth running of the system, ahead of official inspections. Processing reports of suspected cases of adverse drug reactions is a volmue issue of any PV 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.

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.

Designing Efficient Pharmacovigilance Systems

It is much less common for these drugs to have serious adverse reactions. EudraLex Volume 9A requires Marketing Authorisation Holders to invest considerable manpower and financial resources in monitoring the safety of pharmaceutical products.

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. 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 voolume PV-related information. 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.

Some companies outsource all their PV tasks so voluume to ensure that they instantly have a fully functioning PV system. Records must be kept of the initial and further training of the personnel who are assigned PV activities. This includes “more detailed information for example about the product range, vollume SOPs, about further training documentation or further facilities.

External audits conducted from an outside perspective enables companies to see how they match up the ideal situation generally required by the authorities.