Only 7 days left for consultations. The Ministry of Health's regulation comes ahead of the law amendment.
- The project consultation period has been shortened to 7 days due to the 30-day deadline for the entry into force of the Act amending the Pharmaceutical Law.
- The regulation specifies the method of confirming the competences of candidates for Qualified Persons and Competent Persons who do not hold a Master's degree in Pharmacy
- Candidates for Qualified Person and Competent Person positions will be required to submit documents certifying their education and professional experience.
- Requirements regarding knowledge of the Polish language have also been established.
The draft regulation of the Minister of Health on the certification of qualifications of Qualified Persons and Competent Persons has been submitted for shortened public consultation. Consultants have only seven days to submit any comments, as the regulation is supplementary to the Act of September 12, 2025, amending the Pharmaceutical Law , so the regulations should enter into force simultaneously.
The proposed regulation establishes a uniform method for confirming the competences of candidates for Qualified Persons and Competent Persons who do not hold a Master of Pharmacy degree .
According to the regulation, candidates for Qualified Persons and Competent Persons are required to hold a diploma from a uniform master's degree program or a second-cycle program. Confirmation of knowledge will not only be provided by the diploma; candidates will also be required to submit appropriate supplements .
For candidates for Qualified Persons, verification of competencies will be straightforward. Article 48, paragraph 1, point 2 of the Pharmaceutical Law provides for a closed list of subjects. However, when it comes to requirements regarding the knowledge and experience of a Competent Person (Article 38a, paragraph 13, point 2 of the Pharmaceutical Law), the regulations are general and imprecise. Fulfillment of these requirements will be assessed individually, based on documents submitted by the candidate, in accordance with the proposed regulation.
Another discrepancy in the qualifications assessment concerns the requirements for work experience . A candidate for a Competent Person, unlike a Qualified Person, does not need to provide separate proof of internship completion. However, they must provide employment documents to demonstrate relevant experience in the production of individually tailored medicinal products in a hospital setting. In practice, this requires proof that the candidate has professional experience in this type of drug production, even if they have not completed a formal internship.
The regulation also specifies requirements for Polish language proficiency . Applicants who do not hold Polish citizenship will be required to provide official certification of their Polish language proficiency at least at a B2 level.
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