New draft Regulation of the Minister of Health on entities authorised to purchase medicinal products from pharmaceutical wholesalers
On 18 March a new draft regulation of the Minister of Health on entities authorised to purchase medicinal products from pharmaceutical wholesalers was placed on the website of the Government Legislation Centre. The regulation extends the list of entities which will be able to purchase medicinal products from pharmaceutical wholesalers.
One of the most important changes contained in the draft concerns the possibility of supplying medicinal products in wholesalers by medical entities. The new legislation assumes that medicines may be purchased from wholesalers by medical entities which conduct activity in the form of stationary 24-hour health services and AOS, and which also have a hospital pharmacy or a hospital pharmacy department. In the case of other entities, it will be possible to purchase medicines specified in the regulation issued pursuant to Art. 68 (7) of the PF (medicines included in anti-shock kits and medicines provided on an ad hoc basis in connection with the provision of healthcare services).
In the new version of the regulation, the Ministry of Health also proposes an additional restriction concerning serialization of medicines and withdrawal of individual identifiers of medicinal products, indicating that it will not be possible for the DPS to purchase medicinal products subject to serialization from pharmaceutical wholesalers. At the same time, such an exclusion does not apply to other entities, which by virtue of the regulation are to be able to purchase medicines from pharmaceutical wholesalers. However, the Ministry of Health stipulates that such entities will be able to supply serialised medicinal products only if they verify the security features themselves and withdraw individual identifiers from the system. On the other hand, if they supply such medicines without fulfilling the obligations resulting from the Falsification Directive, they must take into account potential negative consequences (penalties).