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Summary of Pharmacovigilance System (SPS)

#1 · December 7, 2020, 2:52 PM

Quote from VigiServe Admin on December 7, 2020, 2:52 PM

Applicants for marketing authorisation are required to provide a summary of their pharmacovigilance system, in accordance with Article 8(3)(ia) of Directive 2001/83/EC, which they will introduce once the authorisation is granted.

The requirement for the summary of the pharmacovigilance system was introduced by the new pharmacovigilance legislation (Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC).

The summary of the pharmacovigilance system should be provided in Module 1.8.1 of the application for marketing authorisation and includes the following elements:

proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance, the Member States in which the qualified person resides and carries out his/her tasks, the contact details of the qualified person, a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC, a reference to the location where the pharmacovigilance system master file (PSMF) for the medicinal product is kept.

The MAH may combine this information in one single statement using the required statement as per Article 8(3)(ia) of Directive 2001/83/EC regarding the obligation to have the necessary means to fulfil the tasks and responsibilities listed in Title IX (Pharmacovigilance). Such statement should be signed by an individual who can act on behalf of the legal entity of the applicant/MAH and by the qualified person responsible for pharmacovigilance (QPPV). The title, role and responsibility of each individual signing the statement should be clearly specified in the document.

The summary of the pharmacovigilance system is specific to each application/marketing authorisation as per the legislation and therefore should be signed by the relevant applicant/MAH. The requirement for the summary of the pharmacovigilance system is the same for any marketing authorisation application, independent of the legal basis for the application.

Applicants for marketing authorisation are required to provide a summary of their pharmacovigilance system, in accordance with Article 8(3)(ia) of Directive 2001/83/EC, which they will introduce once the authorisation is granted.

The requirement for the summary of the pharmacovigilance system was introduced by the new pharmacovigilance legislation (Directive 2010/84/EU amending, as regards pharmacovigilance, Directive 2001/83/EC).

The summary of the pharmacovigilance system should be provided in Module 1.8.1 of the application for marketing authorisation and includes the following elements:

proof that the applicant has at his disposal a qualified person responsible for pharmacovigilance, the Member States in which the qualified person resides and carries out his/her tasks, the contact details of the qualified person, a statement signed by the applicant to the effect that the applicant has the necessary means to fulfil the tasks and responsibilities listed in Title IX of Directive 2001/83/EC, a reference to the location where the pharmacovigilance system master file (PSMF) for the medicinal product is kept.

The MAH may combine this information in one single statement using the required statement as per Article 8(3)(ia) of Directive 2001/83/EC regarding the obligation to have the necessary means to fulfil the tasks and responsibilities listed in Title IX (Pharmacovigilance). Such statement should be signed by an individual who can act on behalf of the legal entity of the applicant/MAH and by the qualified person responsible for pharmacovigilance (QPPV). The title, role and responsibility of each individual signing the statement should be clearly specified in the document.

The summary of the pharmacovigilance system is specific to each application/marketing authorisation as per the legislation and therefore should be signed by the relevant applicant/MAH. The requirement for the summary of the pharmacovigilance system is the same for any marketing authorisation application, independent of the legal basis for the application.