On Friday, October 28, 2022, a draft act amending the Pharmaceutical Law and certain other acts was published on the website of the Government Legislation Centre.
The draft act provides, inter alia, the verticalization of the State Pharmaceutical Inspection, regulation of supervision over medical diagnostic laboratories and introduction of new rules for conducting control by the Chief Pharmaceutical Inspectorate. Another proposal that is relevant for pharmaceutical market entities is the introduction of an annual fee for holding authorisations and entries into registers, including manufacturing and import authorizations of medicinal products as well as wholesale distribution authorizations.
The draft act has been referred to inter-ministerial and public consultation.
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