Proposed deregulation of pharmaceutical law
Marketing authorisation holders will no longer have to inform the Integrated System for Monitoring Trade in Medicinal Products of the planned place of delivery of medicines, and it will be easier for persons authorised to issue prescriptions to obtain drug samples. The Polish government has approved these deregulatory proposals in the healthcare field, to be achieved by amending the Pharmaceutical Law. There are also plans to modify the requirements for qualified persons.
Easier to request drug samples
This proposed change involves Art. 54(3) of the Pharmaceutical Law. The rules now require a person authorised to issue prescriptions to apply in writing to the trade representative or medical representative for samples of medicinal products. This makes it necessary to sign the request by hand or using a qualified electronic signature.
The person delivering drug samples is required to maintain records of the samples they release, and the sample cannot be larger than the smallest package of the product admitted to trading in Poland. The packaging of the sample must be clearly marked “free sample—not for sale” and also contain the current summary of product characteristics (ChPL). And no more than five samples of the same drug can be delivered to the same person during the course of one year.
The amendment would simplify this procedure, allowing the request for samples to be submitted in “document form” as an alternative to “written form.” Document form means that it is enough to make the request in a manner enabling identification of the person making the request. In practice, this means that a request for samples could be submitted for example by email, SMS, or other electronic document, without a qualified signature.
Such a request would be considered properly submitted in document form so long as it enables the recipient to identify the applicant, the date of the request, and the contents of the request. But the possibility of verifying whether the person requesting a sample is authorised to prescribe medicines would remain in place.
Lifting the duty to designate the planned place of delivery of medicines
The next healthcare deregulation proposal would amend Art. 36z of the Pharmaceutical Law. Currently, marketing authorisation holders (MAHs) must submit information to the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL) on the planned place of delivery of medicinal products, among other information.
But in practice, pharmaceutical companies are not in a position to state in advance which of the over 400 pharmaceutical warehouses in Poland a given supply will be delivered to. Logistical decisions are often made at a later stage in the distribution process. Thus it can be difficult to comply with the requirement to designate the planned place of delivery, a rule that places unnecessary administrative burdens on MAHs.
According to the Ministry of Health, this duty is not particularly relevant in terms of monitoring the availability of medicines, and also ends up duplicating the data gathered in the system. The actual place of delivery can be determined on the basis of the daily reports by pharmaceutical warehouses, which are also submitted to ZSMOPL.
Thus the proposed amendment would eliminate the duty for MAHs to report the planned place of delivery. The proposed change would meet the calls for deregulation from social partners, with which the ministry agrees.
Both bills have been adopted by the Council of Ministers, and are currently being considered in parliamentary committees.
Change in requirements for the position of qualified person
Another deregulation bill has been published on the website of the Government Legislative Centre, with the aim of revising the requirements for a qualified person under Art. 2(21c) of the Pharmaceutical Law—that is, the person responsible for ensuring before medicines are introduced into trade that each batch of the product was manufactured and inspected in compliance with the regulations and the requirements that are the basis for issuing marketing authorisation for the product. The bill concerns the regulations indicated in Art. 48(1)(1) of the law.
Currently, a qualified person must hold a specific professional title, and have completed studies within one of the areas of science exhaustively listed in the law (biology, chemistry, pharmacy, medicine or veterinary science). But these rules refer to an outdated classification of fields of study and since-repealed regulations (Art. 191a(1)(2)–(3) and 191a(2) of the Higher Education Law, which ceased to be in force in 2018). Consequently, it is hard to match the requirements to the current academic and technical realities.
The aim of the proposed amendment is to remove outdated rules and increase the flexibility of the requirements for qualified persons. The bill would include in Art. 48 of the Pharmaceutical Law a cross-reference to the current higher education regulations, consistent with the current system of fields of study.
The proposal would also authorise the Minister of Health to issue an executive regulation defining the subjects which a candidate must study to become a qualified person, and the manner of verifying fulfilment of these requirements. This should ensure that the person has a level of knowledge and skill adequate to their duties, while unifying the procedures for assessment of their qualifications.
The bill also provides that persons who are already acting as a qualified person at the time the new rules go into effect, and who met the existing requirements, can continue to perform their tasks.
On 26 May 2025 the proposal to deregulate the requirements for qualified persons was released for public consultations.
Joanna Krakowiak, attorney-at-law, Karolina Hryckowian, Life Sciences & Healthcare practice, Wardyński & Partners
