Inspection of pharmacovigilance systems

Types of inspections

The order of priority for inspections is:

1. EU inspections requested by the CHMP/CVMP (Committee for Human Medicinal Products/Committee for Veterinary Medicinal Products) and/or the PRAC (Pharmacovigilance Risk Assessment Committee).
2. Supervisory Authority inspections, where the Swedish MPA is the competent authority.
3. Targeted inspection, where potential deficiencies in the pharmacovigilance system have been identified by the national authority.
4. Routine inspections.
5. Coordinated inspections where inspectors from different Member States requestto carry out a coordinated pharmacovigilance inspection
   1. of a MAH with mutually recognised products and the QPPV (responsible for the pharmacovigilance system according to the EU regulatory framework) in Sweden
   2. of a MAH with nationally authorised products.

How is an inspection carried out?

An inspection is carried out over 2-5 days. The exchange of information within the EU inspectorate, as well as with the European Medicines Agency (EMA), is ongoing.

The inspector notifies the MAH 4-6 weeks before a planned routine inspection and at that time the relevant documentation is also requested.

Example of documentation:

• Pharmacovigilance System Master File (PSMF)
• Standard Operating Procedure (SOPs) and instructions
• listings of adverse reaction reports
• any other documentation that may be necessary for the evaluation of the pharmacovigilance system.

An inspection plan is sent to the company about one week before the inspection.

A large number of documents are requested during the inspection. Examples of what may be requested are:

• curriculum vitae and training cards
• information related to individual case reports
• summaries of reported adverse reactions
• Periodic Safety Update Reports (PSURs)
• Risk Management Plans (RMPs)
• agreements with other organisations, companies and partners
• notes and minutes of the meeting.

The inspection team needs a separate room for interviews and review of documentation.

Findings

Findings with respect to the applicable regulations are graded.

This is done in the final report sent to the company approximately 30 days after the end of the inspection, with the exception of critical findings which are notified  at the inspection for immediately actions.

Upon receipt of the inspection report, the company must submit an action plan known as CAPA (Corrective Action and Preventive Action), usually within 30 days.

The Swedish Medical Products Agency (Swedish MPA) notifies the MAH that the case is closed when all the findings of the action plan are considered implemented and acceptable.

Summary of requirements for herbal medicinal products

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Processing of personal data for the purpose of inspection

Personal data will be processed by the Swedish MPA in connection with inspections and other supervision of safety monitoring systems/pharmacovigilance systems.

Personal data may include:

• name, position and contact details (email address, address, telephone number) of the persons with whom we correspond regarding the implementation of the inspection
• name and position (in some cases also contact details and previous experience/training) of key personnel in the activity being inspected, and any contractors
• name and position of any other persons present at the inspection
• any sensitive personal data or other personal data contained in the information under review.

The purpose of the processing of personal data is the control and supervision of safety monitoring systems (pharmacovigilance systems) for companies holding marketing authorisations for medicinal products in Sweden. The legal basis for the processing is ‘a legal obligation’, the exercising of official authority and the necessity for a task to be carried out in the public interest.

Personal data that is collected will be retained in accordance with the relevant archive legislation and documentation plans.

The Swedish MPA is the data controller for the processing. If you want to know if the Swedish MPA is processing your personal data, please contact the Agency.

If you want to change, add, request restriction or erase information about yourself, you can also contact the Swedish MPA. You also have the right to object to the processing of your personal data in certain cases.

If you have a complaint about the processing of your personal data by the Swedish MPA, you may contact the Swedish MPA and/or the Swedish Data Protection Authority.

Läkemedelsverket
Box 26
751 03 Uppsala

Växel: 018-17 46 00

E-post: registrator@lakemedelsverket.se