The pharmacovigilance system master file request pdf. The pharmacovigilance system master file is actually a detailed description of the pharmacovigilance and safety procedures which a company follows when handling a product. Companies applying for or holding marketing authorizations mas for biopharmaceutical products in the eea must have a critical document on file. Pharmacovigilance system master file coberts manual of drug. Kes director for distribution control of therapeutic and household healthcare products. It is a very useful document for the regulators and the mah which ensures that noncompliance issues or deficiencies in the pharmacovigilance system will get detected. Pharmacovigilance system master file sj pharma consulting llc. Global implications of the eus pharmacovigilance system. Pharmacovigilance system master file psmfwas issued, and initially came into effect on 2.
Establish and maintain a system, accessible at a single point in the eu, to collect. Pharmacovigilance system master file coberts manual of. Overview of the eu phv system prac pharmacovigilance and risk assessment committee 4 7 scientific committees chmp, cvmp, comp, hmpc, pdco, cat. Request pdf the pharmacovigilance system master file july 2012 has brought new requirements in the pharmacovigilance pv area, aiming to improve the way patients safety is monitored. Practical approaches to the pharmacovigilance system. Pharmacovigilance system master file european commission.
An introduction to the pharmacovigilance system master file. Audit audits of the quality system shall be performed at regular intervals, and not less than every. As the scope and complexity of activities required of the pharmacovigilance. This is an introductory session to the eu psmf which will cover the regulatory basis of the psmf, its purpose, how it is maintained and revised, what information is included in the psmf, some. An introduction to the pharmacovigilance system master file scott. Authorizations mas for biopharmaceutical products in the eea must have a critical document on file. Transperfect one of the many challenges in clinical trials, for both compounds and medical devices in development, is the need to rapidly communicate any potential safety concerns or findings, during pharmacovigilance, to all applicable regulatory authorities. An introduction to the pharmacovigilance system master file 1. Master file psmf we help marketing authorisation holders. A product is considered to be on the market whilst it remains available to patients i. Sj pharma consulting, llc in mendham, nj has created a template for the pharmacovigilance system master file that fulfills the requirements of the new eu pv legislation.
Pharmacovigilance inspection metrics report 201220 final. The psmf provides a detailed description of the entire pharmacovigilance system for the organisation and documents the performance and compliance with the requirements as described by good pharmacovigilance. In order to accurately reflect the pharmacovigilance system used by the marketing authorisation holder, the pharmacovigilance system master file should contain key information and documents covering all aspects of pharmacovigilance activities, including information on tasks that have. A logbook of any change of the content of the pharmacovigilance system master file made within the last five years except the changes in annexes and the following qppv information. Guidance to marketing authorisation holders mah on the new. Pharmacovigilance system master file clinical leader. To be innovative, credible, internationally recognized institution on drug and food control to. Jul 08, 20 the requirement for a pharmacovigilance system master file psmf has been in place since july 2012 for all centrally approved products or at the time of the application or renewal for nationally. Pharmacovigilance system master file psmf primevigilance offers an extensive network of local qppvs or more accurately known as national persons responsible for pharmacovigilance nprp in the european economic area eea countries where the provision of an nprp is required by national law at the time a market authorization is submitted. Industrys most important obligation established by this document is the need to identify a pharmacovigilance officer incharge pvoi, as defined in module 1 of the pharmacovigilance system master file pvmf, who shall have sufficient authority over the pharmacovigilance system and be responsible for compliance. Module ii pharmacovigilance system master file rev 2.
Its aligned with global regulations and provides more accurate information to authorities. Pharmacovigilance system master file psmf voisin consulting. Oct 19, 2016 provides a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods used in, or exported from, australia. Pharmacovigilance system master file psmf online virtual. The information contained in the pharmacovigilance system master file should be maintained so as to reflect any modifications that have been made and ensure easy accessibility and availability by the national competent authorities for the purpose of inspections. A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products the 2010 directive and regulation do not contain details on the content and maintenance of the psmf. Click here to see our pharmacovigilance system master file that fulfills the requirements of the new eu pv legislation. The government of the republic of zambia has since established the national pharmacovigilance unit under the pharmaceutical regulatory authority to coordinate the pharmacovigilance programme in the country. The pharmacovigilance system master file pharmaphorum. You must acknowledge you have received the notification and provide details of the. The content of the pharmacovigilance system master file should reflect global availability of safety information for medicinal products authorized in the country, with information on the pharmacovigilance system not just confined to local or regional activities. Uae moh guidelines in good vigilance practice gvp for.
The psmf is a modular document containing all of the details of the pharmacovigilance system for the product. Dec 18, 2014 as part of the inspection notification, the pharmacovigilance system master file psmf will be requested. In order for such a system to be successful, there is need to engage all health care professionals in a wellstructured programme. The pv system master file psmf is a very useful tool. Basic principles of pharmacovigilance and data sources. Guideline on good pharmacovigilance practices gvp module ii pharmacovigilance system master file rev 2 date for coming into effect of first version 2 july 2012 date for coming into effect of revision 1 12 april 20 draft revision 2 finalised by the agency in collaboration with member states 9 march 2017. Pharmacovigilance system master file psmf, qppv and.
The request a pharmacovigilance system master file psmf was introduced by. Summary of the pharmacovigilance system psmf phvig system master file what information should be included new applications received from now on, must contain a summary of the pharmacovigilance system and not a. The pharmacovigilance system manual sets out the key principles for monitoring the performance of the ema pharmacovigilance system and reporting on the ema pharmacovigilance tasks, as laid down in the legislation. Guideline on good pharmacovigilance practices gvp for arab countries page 5 532 preface pharmacovigilance has been defined by the world health organization as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicinerelated problem. If needed we provide missing sops based on the processes and structure of your company. Many mahs will wish to transition from the ddps to the pharmacovigilance system summary and master file at the earliest opportunity e. Flex databases pharmacovigilance software is a secure and validated pv system which serves as a single point of entry, assessment and reporting of safety data. Regulation eu no 12352010 amending regulation ec no. Establish and maintain a system, accessible at a single point in the eu, to collect, collate, and evaluate pharmacovigilance data meet legal obligations for reporting suspected adverse drug reactions meet legal obligations regarding the preparation and the submission of psurs.
Pharmacovigilance system master file psmf, qppv and audits. Summary of the pharmacovigilance system psmf phvig system master file. Workshop 2 considerations for drafting an annex inspection findings related to the psmf discussion of some of the inspection findngs and deficiencies related to the structure and maintenance of the psmf. Aug 30, 2016 pharmicas pharmacovigilance system master file webinar. Summary of the pharmacovigilance system psmf phvig system master file 2. The pharmacovigilance system master file shall be located either at the site in the eu where the main pharmacovigilance activities of the marketing authorisation holder are performed or at the site where the qualified person responsible for pharmacovigilance operates im art 31, irrespective of the format paperbased or electronic. Comparison of eupharmacovigilance system master file psmf. Pharmacovigilance requirements continue as long as a product is on the market. Pharmacovigilance exists to ensure the safety of development for medicinal products. Module i pv systems and their quality systems and module ii pharmacovigilance system master file psmf outline the framework for the kpis. In the eu, the use of performance indicators is defined in the modules of good pharmacovigilance practices gvp to continuously monitor the quality of key processes in pv. Applies scientific and clinical expertise to decision making.
Uae moh guidelines in good vigilance practice gvp for marketing authorization holders pharmaceutical manufacturers in uae page 4 introduction pharmacovigilance pv has been defined by the world health organization who as the science and activities relating to the detection, assessment, understanding and prevention of. Matthijs nele, phv inspector, dg inspection pharmacovigilance. It must be made available to a competent authority. The ema pharmacovigilance system in the context of the ema quality system imp incident management plan. Nov 06, 20 an introduction to the pharmacovigilance system master file 1. A detailed description of the pharmacovigilance system used by the marketing authorisation holder with respect to one or more authorised medicinal products. Pharmacovigilance system master file and psmf, to date the topic areas representing the largest proportions of inspection findings remain the same as in previous reporting periods. Pharmacovigilance system master file european medicines agency. The pharmacovigilance system master file psmf is a legal requirement for any medicinal product authorised in the european union eu. Basic principles of pharmacovigilance and data sources joerg hasford, m. An introduction to the pharmacovigilance system master file scott mcculloch, pharmacovigilance solutions director transperfect life sciences november 5, 20 2.
Cv, contact details, backup arrangements and contact details. Pharmacovigilance automation software flex databases. In terms of monitoring and collecting safety information, your pharmacovigilance system should allow you to. At the conclusion of this tutorial, participants should be. Quality systems should form an integral part of the pharmacovigilance system. White paper a practical guide to achieving and maintaining. Third stakeholders forum on the third stakeholders forum on the implementation of the new pharmacovigilance. In europe, a new guideline on good pharmacovigilance practicesmodule ii. The pharmacovigilance system master file psmf is a detailed collection of information that specifies all aspects related to how a pharmaceutical company is conducting pharmacovigilance. Pharmacovigilance system master file psmf qvigilance. Discussion about strategies to maintain and update various sections of the psmf to ensure the document is reflective of the pv system. A practical guide to achieving and maintaining global oversight and ensuring endtoend pharmacovigilance.
Practical approaches to the pharmacovigilance system master. Gvp module vi includes requirements and recommendations for. A pharmacovigilance system master file is a document describing the pharmacovigilance system used by the marketing authorisation holder mah with. Pharmicas pharmacovigilance system master file webinar. Comparison of eupharmacovigilance system master file. Pharmacovigilance system master file psmf primevigilance.
It should not be considered as a document only but as a tool that supports active governance of the pv system. Request pdf the pharmacovigilance system master file july 2012 has brought new requirements in the pharmacovigilance pv area, aiming to improve the. Cso pharma realises and updates the legal required pharmacovigilance system master file system compliant with regulation no. The requirement for a pharmacovigilance system master file psmf has been in place since july 2012 for all centrally approved products or at the time of the application or renewal for nationally. So it is defined as a detailed description which it also is at least in the summary of the pharmacovigilance system, but in practical terms most of. Have in place national pharmacovigilance systems inform the european commission, the cpmp, the agency, the member states and. Your pharmacovigilance system should meet any applicable recordkeeping and reporting requirements. For marketing authorisation holders this shall be done in an annex to the pharmacovigilance system master file. Other change control documentation should be included as appropriate. The purpose with the psmf is first to provide the qppv with a constantly updated oversight with the pharmacovigilance system and in addition to ensure that. Pharmacovigilance system master file steen ottosen aps. Implement a riskproportionate audit program for the pv system, which should cover all. Pharmacovigilance system master file psmf provision of a national person responsible for pharmacovigilance nprp eu directive 201084eu amending 200183ec requires each application for marketing authorisation ma for the eu to have a pharmacovigilance system master file psmf in place including the named qualified person responsible.
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