Pharmacovigilance system master file

Change control, logbook, versions and archiving

As a basis for audit and inspections, the PSMF provides a description of the pharmacovigilance system at the current time, but the functioning and scope of the pharmacovigilance system in the past may need to be understood.

PSMF presentation

A record of the date and nature of notifications of the changes made available to the national medicines authorities, the QPPV and relevant third parties should be kept in order to ensure that change control is fully implemented.

The pharmacovigilance system master file shall be continuously accessible to the QPPV and to the national medicines authorities on request. The information shall be accurate and reflect the current system in place

14 days

Special consideration for multinational MAHs/applicants

1- PSMF (global pharmacovigilance system).

2- National pharmacovigilance sub-system

file (national PSSF).

Multinational MAHs/applicants

MAH

PSMF

PSSF

PSMF

New marketing authorization applications (pre-authorization)

The full PSMF/ PSSF (along together with its summary) is requested to be submitted in the following situations.

1- The applicant has not previously held a marketing authorization in the Arab Country concerned.

2- The applicant has not previously submit the PSMF in the Arab Country concerned or is in the process of establishing a new pharmacovigilance system.

3- The applicant had major changes in its organization, such as mergers.

Pre-authorization

6- Where specific concerns about the pharmacovigilance system and/or the product safety profile exist.

7- Any other situation as seen appropriate by the national medicines authority.

4- The applicant has major or critical findings in the previous pharmacovigilance system assessment by the national medicines authority.

5- The applicant has a history or culture of pharmacovigilance non-compliance (e.g. inspection history and non-compliance notifications or information from other authorities).

Conditions to submit the PSMF and the national PSSF

Post-authorization

The full PSMF and the national PSSF may be requested by the national medicines authority in the following situations:

1- Particularly if a new pharmacovigilance system is being implemented or the MAH has not previously submit the PSMF and the national PSSF in the Arab Country concerned.

2- If product specific safety concerns or issues with compliance with pharmacovigilance requirements have been identified.

3- In preparation for an pharmacovigilance inspection.

4- Any time upon request of the national medicines authority.

Information to be contained in the PSMF

Qualified person responsible for pharmacovigilance (QPPV)

Checklist

The organizational structure of the marketing authorization holder

Checklist

The sources of safety data

Checklist

Pharmacovigilance processes

Checklist

Computerized systems and databases

Pharmacovigilance system performance

Checklist

Annex

Checklist

Quality system

Checklist

Pharmacovigilance system master file

Definition

The pharmacovigilance system master file is a detailed description of the pharmacovigilance system used by the marketing authorization holder with respect to one or more authorized medicinal products.

Paper or electronic format file

MAH (more than one PSMF, e.g. particular types of products.

PSMF (may include products from more than one MAH).

QPPV PSMF

Registration and maintenance

Summary of the applicant’s pharmacovigilance system

Transfers of responsibilities for the PSMF

The pharmacovigilance system may change with time.

1- Qualified person responsible for pharmacovigilance.

2- Country (qualified person).

3- Contact details.

4- Statement signed by the applicant (fulfil the Phv. tasks and responsibilities in the GVP modules.

5- PSMF location.

6- Transfer of significant services for pharmacovigilance to a third party (contracts and agreements).

7- Inclusion of products into pharmacovigilance system or changes for existing products (e.g. new indications).

1- PSMF location.

2- QPPV/ LSR.

3- Changes to the pharmacovigilance safety database.

4- Addition of corrective and/or preventive actions.

5- Organizational changes (mergers).

Location

Registration

National medicines authority list/ database (up-to-date information about the MAH's pharmacovigilance system master file.

The pharmacovigilance system master file shall be located either at the site where the main pharmacovigilance activities are performed or at the site where the qualified person responsible for pharmacovigilance operates.

Taqwa Maqatef

Master of clinical pharmacy

RDU& PV department/ JFDA