- Volume manager note 4 update#
- Volume manager note 4 professional#
Good practice guide on recording, coding, reporting and assessment of medication errors.Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products.Standards and guidances of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).
Volume manager note 4 update#
Union reference dates and submission of periodic safety update reports.European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 3.Consideration on core requirements for RMPs of COVID-19 vaccines.Pharmacovigilance: regulatory and procedural guidance.Where GVP modules refer to the European Medicines Agency's and the Heads of Medicines Agencies' procedural advice on referral procedures for safety reasons, consult referral procedures page.įor other pharmacovigilance guidance developed outside the GVP process, see:.
These documents can be found on the Periodic safety update reports: questions and answers page. Once the updated GVP module is published this guidance will be removed. These documents should be considered as interim guidance until the GVP VII module is revised as per the established process.
In relation to the GVP VII module please note that an explanatory note and a question and answer guidance document for assessors have been developed to clarify certain aspects of the single assessment that are specific to nationally authorised products. Please note the document on reporting requirements of marketing authorisation holders in the EU regarding suspected adverse reactions occurring with medicinal products they donate outside the EU to public health programmes against neglected tropical diseases. Where GVP chapters refer to Module XIII, consult the Agency's page on the incident management plan. Where GVP chapters refer to Module XII, consult the Agency's page on post-marketing authorisation: regulatory and procedural guidance for human medicinal products. Where GVP chapters refer to Modules XI or XIV, consult the Agency's page on partners and networks. Superseded pharmacovigilance guidance documents. GVP modules and considerations are regularly reviewed for revision needs and schedules. 
EMA plans one more consideration chapter as follows: Chapter number The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population. Product- or population-specific considerations The module numbers XI, XII, XIII and XIV stay void, as their planned topics have been addressed by other guidance documents on the Agency's website (see bullet points below Final GVP modules table). GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. Modules covering major pharmacovigilance processes
product- or population-specific considerations. modules covering major pharmacovigilance processes. The guideline on GVP is divided into chapters that fall into two categories: The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislation.Įach chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). Submitting a post-authorisation application. Post-authorisation efficacy studies (PAES). Volume manager note 4 professional#
Direct healthcare professional communications. Changing the labelling and package leaflet (Article 61(3) notifications). 
Changing the (invented) name of a medicinal product.
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