Publication date: October 07, 2025
Pharmacovigilance under Polish law
The purpose of an inspection of the pharmacovigilance system for medicinal products intended for human use (pharmacovigilance inspection) is to verify how the marketing authorization holder for medicinal products is fulfilling its obligations regarding the pharmacovigilance system imposed by Polish and European Union law.
Inspection Basis
Inspections of the pharmacovigilance system are conducted by inspectors from the Department of the Inspection of Medicinal Products and Medical Devices, authorized by the President of the Office. Inspectors are authorized to:
– inspect the marketing authorization holder (MAH) regarding the pharmacovigilance system
– request documentation related to ensuring the functioning of the pharmacovigilance system
– request clarification regarding ensuring the functioning of the pharmacovigilance system
Inspection Process
The inspection of the pharmacovigilance system consists of, among other things:
– verification of the pharmacovigilance system documentation
– interviews with responsible employees, including the QPPV
– checking databases
– insight into the organizational procedures
Inspection
The inspection begins with an opening meeting, which serves to introduce the inspection team and define the purpose and scope of the inspection.
The team will need a room/office where they can interview relevant employees and review documentation.
On the last day of the inspection, during a closing meeting, the inspection team presents their observations and describes any discrepancies in the functioning of the pharmacovigilance system.
What information do inspectors expect from the entity subject to inspection?
Before commencing the inspection, the marketing authorization holder (MAH) is requested to submit a copy of the full description of the Pharmacovigilance Management System (PSMF).
In addition, the MAH should provide inspectors with access to documentation regarding, among other things:
– standard operating procedures, work instructions,
– source documentation for individual case reports (ICSRs),
– periodic safety update reports (PSURs),
– risk management plans for the use of the medicinal product,
Inspection Report
The results of the inspection are presented in an inspection report, which is prepared within 30 days of the inspection completion date. The report is then submitted to the President of the Office for approval. The approved report is forwarded to the MAH.
Types of Inspections:
Routine inspection – conducted after prior notification to the MAH, sent no later than 30 days before the planned inspection.
Targeted inspections are conducted after prior notification to the responsible entity, sent no later than 14 days prior to the planned inspection.
Unannounced inspections are conducted when there is a suspicion that a system malfunction poses a threat to patient life.
It is worth pointing out that apart from Article 24a of Pharmaceutical Law, Chapter 2 of the Act also applies (Article 36b-36z). The Pharmaceutical Law Act regulates pharmacovigilance, in a scope much broader than the inspection itself. The said chapter defines the tasks of the President of Office for the Registration of Medicinal Products, situations in which the Act imposes the obligation to report adverse reactions to the President of the Office, the patient’s right to report adverse reactions, and, among others, the obligations of the marketing authorization holder (MAH) who has obtained a marketing authorization (MAH – Marketing Authorization Holder), which include, for example, maintaining a pharmacovigilance system, appointing a person responsible for safety surveillance and reporting his/her data to the President of the Office, collecting, registering and reporting adverse reactions to medicinal products, presenting, at each request of the President of the Office, within 7 days, a copy of the full description of the safety surveillance system for medicinal products, conducting regular audits, and cooperating with the EMA.
Control under European law:
Significant changes have occurred with the publication of Commission Implementing Regulation (EU) 2025/1466 of 22 July 2025, amending Implementing Regulation (EU) No 520/2012 on activities related to pharmacovigilance. The changes are of various nature, including, among others, reducing the administrative obligations regarding the pharmacovigilance system master file. Implementing Regulation (EU) No 520/2012 specifies, among other things, the content of the pharmacovigilance system master file. To avoid unnecessary administrative burden for applicants and competent authorities, only significant deviations from pharmacovigilance procedures, their impact and their management until the issue is resolved should be documented in the pharmacovigilance system master file, which in particular implies an amendment to Article 4(3).
The same Implementing Regulation introduced new requirements for subcontracting arrangements (added Article 6(3) and (4) and Article 13(1a) of Regulation 520/2012). The marketing authorisation holder may subcontract certain pharmacovigilance system tasks to third parties. However, the main MAH retains full responsibility for the completeness and accuracy of the pharmacovigilance system master file and that the marketing authorisation holder shall draw up a list of existing subcontracting arrangements between himself and third parties. The marketing authorisation holder shall include the following elements in subcontracting agreements: (a) a clear description of the roles and responsibilities of third parties to whom pharmacovigilance activities are subcontracted; (b) a provision obliging third parties to exchange safety data with the marketing authorisation holder and, where appropriate, the method for exchanging safety data; (c) arrangements for the third-party inspection and audit process; (d) a provision obliging third parties to agree to be audited by or on behalf of the marketing authorisation holder and to be inspected by the competent authorities.
Article 13 of the Regulation addresses the auditing requirements imposed by the European legislator on marketing authorization holders. The new wording states in paragraph 1 that: Marketing authorization holders shall conduct risk-based audits of the quality system at regular intervals to ensure its compliance with the requirements set out in Articles 8, 10, 11, and 12 and to determine its effectiveness. Audits, taken individually or in combination, shall cover all pharmacovigilance activities during a designated period and shall verify their compliance with the policies, processes, and procedures defined within the quality system. Audits shall be carried out by persons who are not directly involved in, or responsible for, the matters or procedures being audited. The added paragraph 1a provides that any third party subcontracted to perform all or part of the pharmacovigilance tasks on behalf of marketing authorisation holders or in collaboration with them shall be subject to an audit by or on behalf of the marketing authorisation holders, taking into account the risks associated with subcontracting, and may be subject to an inspection by the competent authorities, even if the subcontracting agreement does not yet include the obligation under Article 6(3).
In addition to audits at regular intervals, audits must be carried out when necessary, including corrective actions and a follow-up audit for non-compliance (Article 13(2)).
The periodic safety update report, in accordance with Article 34 of Commission Implementing Regulation No. 520/2012, contains the results of assessments of the effectiveness of risk minimization activities relevant to the risk-benefit assessment, and from February 2026, will also include information on the implementation of risk minimization measures and the results of the assessment of the effectiveness of the actions taken (Article 34, paragraph 3, new wording).
Another new obligation on the part of MAHs (marketing authorization holders) is to post information on post-authorization safety studies in the EMA electronic register (Article 36, paragraph 5, new wording).
All the changes mentioned above come into force on February 12, 2026; however, the obligation to actively use the EudraVigilance database is different. The amended Article 18, paragraphs 2 and 3 of Regulation 520/2012 obliges MAHs to monitor, but also to use data from the EudraVigiliance database in combination with data from other sources. This obligation has already entered into force, on 12 August 2025, unlike other amendments.
Recital 5 of Commission Implementing Regulation (EU) 2025/1466 explains: “The Eudravigilance database is a system for managing and analysing information on adverse reactions to medicines authorised or undergoing clinical trials. The European Medicines Agency (“the Agency”) and national competent authorities continuously monitor the data in the Eudravigilance database. Marketing authorisation holders also have access to the database to the extent necessary to fulfil their pharmacovigilance obligations. Based on the experience of marketing authorization holders in monitoring data in the Eudravigilance system, the requirements for marketing authorization holders should be clarified, including requirements for approving signals and notifying them to the Agency and national competent authorities. Recital 7 states: “Individual cases of suspected adverse reactions to a medicinal product shall be reported to the Eudravigilance database. Such reports should contain as much information as possible, and to partially standardize them, minimum reporting requirements should be applied to all cases.”
Additionally, Regulation 520/2012 also regulates other issues. Chapter I specifies the pharmacovigilance system master file in terms of structure, content of the system master file and the content of the annex to the system master file. It also introduces rules for system maintenance and specifies the format of documents included in the pharmacovigilance system master file. Chapter II, in turn, specifies the minimum requirements for quality systems for pharmacovigilance activities conducted by marketing authorization holders (the regulations specify the activities covered by the quality system, the requirements that marketing authorization holders must meet in terms of human resources management, e.g., appropriately qualified staff, and the obligation to implement quality procedures and processes to ensure data monitoring, risk minimization, and prevention.
The regulations also specify how data should be recorded and stored, as well as the principles and obligation to conduct audits). The following chapters cover: minimum requirements for data monitoring in the Eudravigilance database, terminology (according to recital 12, the use of terminology, formats, and standards at international level should facilitate the interoperability of systems used for pharmacovigilance activities and avoid duplication of coding of activities concerning the same information. It should also enable easier exchange of information between regulatory authorities at international level), the submission of reports on suspected adverse drug reactions, risk management plans, and periodic safety update reports.
The marketing authorisation holder shall submit the study protocol, the abstract of the final study report and the final study report submitted in accordance with Articles 107n and 107p of Directive 2001/83/EC in English, except for studies conducted in only one Member State and required pursuant to Article 22a of Directive 2001/83/EC. For such studies, the marketing authorisation holder shall submit an English translation of the title and abstract of the study protocol and an English translation of the summary of the final study report.
The marketing authorisation holder shall ensure that all information relating to the trial is recorded and stored in a manner that allows for accurate reporting, assessment and verification of information, and ensures the confidentiality of data relating to trial participants. The marketing authorisation holder shall ensure that the analytical dataset and statistical programmes used to generate the data included in the final trial report are stored electronically and made available for audit and inspection purposes.
When analysing the pharmacovigilance control system, one cannot ignore the so-called soft law, of which the EMA guidelines stand out in particular, such as the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VIII: Post- authorisation safety studies. At this point, the current, applicable version of the GVP Module VIII rev. 3 guidelines has been in force since 2017. The purpose of this document is to ensure a uniform approach in the EU to the design and supervision of PASS (Post- authorization Safety Studies) and to support the relevant authorities (in Poland, this is the President of the office, mentioned earlier) and marketing authorization holders (MAHs). Due to the recent adoption of Implementing Regulation 2025/1466, the adoption of new guidelines, the so-called GVP Module VIII rev. 4, is expected in the near future.
Due to the importance of both Polish and European regulations, and due to the high importance of the guidelines published by the EMA, on May 29, 2025, the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products issued information on studies on the safety and efficacy of the use of a medicinal product conducted after the issuance of authorization – PASS and PAES. It includes, among other things, that: A study on the safety of the use of a medicinal product conducted after the issuance of authorization (Post- authorization safety study (PASS) may be undertaken by the marketing authorisation holder voluntarily or as a result of an obligation imposed by the President of the Office, if there are concerns about the risk associated with the use of a medicinal product or if it is necessary to assess the effectiveness of the measures taken to reduce this risk. If the study will be conducted exclusively in the territory of the Republic of Poland, the marketing authorisation holder shall submit the study protocol to the President of the Office, who shall assess it. Protocols of studies to be conducted in more than one EU Member State should be submitted to the Pharmacovigilance Risk Assessment Committee, which assesses the appropriateness of the proposed protocol. The principles for preparing study protocols and their conduct are included in Commission Implementing Regulation (EU) No 520/2012, Guideline on good pharmacovigilance practices (GVP), Module VIII – Post- authorisation safety studies. It was also indicated that the marketing authorisation holder should register the conducted study in the electronic register maintained by the European Medicines Agency (EMA).