Amended Pharmaceutical Law in Poland (The Act of 7 June 2018 amending the Pharmaceutical Act and certain other acts).
In the amended Pharmaceutical Law (Journal of Laws of 2017, item 2211 and of 2018 items 650, 697 and 1039) in the most visible way, the changes will affect the institution of the Main Pharmaceutical Inspector – this office will be granted new rights, its position will also be strengthened. From now on it will be the competent authority to issue, refuse, revoke, withdraw, and change the permit for the manufacture or import of a medicinal product, by means of a decision; it will also be decisive in the case of medicine production in the so-called advanced therapy.
It is worth mentioning that the obligations to transfer certain data to the Integrated Medicinal Products Monitoring System have been postponed until 30 September 2018. Another important issue related to the amendment of the Pharmaceutical Law in Poland is the restriction of drug export abroad, which is supposed to improve patients’ access to certain groups of medicine. This is to make possible to extend the ban on several types of pharmacy-related activities by one entrepreneur, e.g. pharmaceutical wholesalers. Along with the amendment of the Pharmaceutical Law in Poland, there will change the rules for conducting clinical trials in Poland. Researchers have long called for changes in art. 37m and art. 37r of the Pharmaceutical Law. These changes involve a simplification or a possibly far-reaching de-formalization of bureaucratic obligations, i.e. the need to present specific documents, including the request to start clinical trials, or to abolish the requirement to attach clinical trial contracts concluded between the parties involved in a clinical trial. The activities undertaken by bioethical committees, which in the legislator’s opinion are too time-consuming, will be limited. The Act comes into force after 14 days from the day of its announcement, with the exception of:
1) art. 14-17, which shall enter into force on the day of the announcement, with effect from 1 January 2017 – these are procedural provisions regarding the proceedings being conducted;
2) art. 1 point 3 and 4, which come into force after 3 months from the day of announcement, these provisions apply to clinical trials and related changes;
3) art. 1 point 13 within the scope of art. 48 par. 5, point 14 and art. 5, which come into force on February 9, 2019, defining the concept and the scope of the duties of the so-called Qualified Person.
From the point of view of the changes discussed above, it is worth paying attention to the second point, specifying the moment of entry into force of the adjustments in the regulations dealing with clinical trials, which are undoubtedly a significant change in the context of simplifying the procedural form of this type of research and a certain beginning on the way to a more Europeanized approach in the law by the Polish legislator.
