Changes in Polish pharmaceutical law
On 4th January, 2019 there was initiated the preparation of changes in the Polish Pharmaceutical Law. Such changes are required due to the commencement of a direct applicability in Poland of the delegated regulation of the European Commission No. 2016/161 from 9th February, 2019.
The main aim of such regulation is to prevent falsification of medicines and placing them on the market. Changes in Polish legislation will concern the introduction of a Unique Identifier which will be enabling the verification of the authenticity of medicinal products, as well as the identification of individual packaging. Moreover, Anti-Tampering Devices, sort of security measures, will be introduced to prevent violation of the packaging of medicinal products available on prescription, however, some freedom in selection of measures has been in this respect left to the Polish state.
The changes will also concern the manufacturers of medicinal products, who will have to establish a specific system of databases. The control of entities authorized to purchase medicinal products from pharmaceutical wholesalers (e.g. doctors, nurses, veterinary surgeons, pharmacies, research institutes, universities) will also be made more strict.
Non-compliance with the obligations of the said regulation will be sanctioned by the Chief Pharmaceutical Inspector by, among others, revoking the permission to manufacture or import medicinal products, operating a pharmaceutical warehouse and imposing financial penalties.