Good pharmacovigilance practices

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency (EMA) and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level.

Guideline on GVP

The guideline on GVP was a key deliverable of the 2010 pharmacovigilance legislation.

Each chapter and revisions are developed by a team consisting of experts from EMA and from EU Member States.

The guideline on GVP is divided into chapters that fall into two categories:

• modules covering major pharmacovigilance processes;
• product- or population-specific considerations.

Modules covering major pharmacovigilance processes

GVP modules I to XVI cover major pharmacovigilance processes and the development of this set of guidance is concluded. 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).

Product- or population-specific considerations

The chapters on product- or population-specific considerations are available for vaccines, biological medicinal products and the paediatric population. EMA plans one more consideration chapter as follows:

GVP modules and considerations are regularly reviewed for revision needs and schedules.

Archives of documents

• Archive of development of GVP
• Superseded pharmacovigilance guidance documents

• Where GVP chapters refer to Modules XI or XIV, consult the Agency's page on partners and networks.
• 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 Module XIII, consult the Agency's page on the incident management plan.
• 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.
• 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. These documents should be considered as interim guidance until the GVP VII module is revised as per the established process. Once the updated GVP module is published this guidance will be removed. These documents can be found on the Periodic safety update reports: questions and answers page.
• 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.

• CHMP guideline on safety and efficacy follow-up - risk management of advanced therapy medicinal products

For other templates developed outside the GVP process, see:

• Risk-management plans
• Pharmacovigilance: regulatory and procedural guidance

These pharmacovigilance guidance documents were developed under the previous legal framework but are still valid in conjunction with GVP.

For other pharmacovigilance guidance developed outside the GVP process, see:

• Pharmacovigilance: regulatory and procedural guidance
• Consideration on core requirements for RMPs of COVID-19 vaccines
• Signal management
• EudraVigilance
• European Medicines Agency policy on access to EudraVigilance data for medicinal products for human use - Revision 3
• Union reference dates and submission of periodic safety update reports
• Guideline on registry-based studies - Scientific guideline
• Standards and guidances of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)
• Guideline on key aspects for the use of pharmacogenomics in the pharmacovigilance of medicinal products
• Good practice guide on recording, coding, reporting and assessment of medication errors
• Good practice guide on risk minimisation and prevention of medication errors
• Risk minimisation strategy for high strength and fixed combination insulin products, developed as an addendum to the good practice guide on risk minimisation and prevention of medication errors

Also, note the Rules of Procedure of the Pharmacovigilance Risk Assessment Committee (PRAC).

• E2C(R2)Implementation working group ICH E2C(R2) Guideline: Periodic benefit-risk evaluation report questions & answers
• ICH M1 Medical Dictionary for Regulatory Activites (MedDRA)
• MedDRA support documentation
• ICH M2 electronic standards for the transfer of regulatory information (ESTRI) is available on multidisciplinary guidelines.

Those participating in the public consultation are asked to submit comments via the EU survey tool linked here.

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