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Historical outline

Historical outline


During the last few years quite essential changes have happened in the area of pharmaceutical inspection. The most important of them took place between 1999 and 2000.

With the date of 1st January 1999, under the article 79 of 24th July 1998, about changing some Acts determining the competences of public administration institutions - in connection with reform of country administration (Journal of Law No. 106 item 668), changes were introduced to the Act of 10th October 1991 on pharmaceuticals, medical materials, pharmacies, warehouses and Pharmaceutical Inspection (Journal of Law No. 105 item 452 with further changes). Under the power of these changes, National Pharmaceutical Supervision was reorganized. It was transformed into Pharmaceutical Inspection. Performance of tasks, which earlier belonged to Pharmaceutical Inspection was entrusted to Chief Pharmaceutical Inspector, and to the governors, who execute their tasks with the help of provincial pharmaceutical inspector.

The reorganization has significantly changed the previous organization of public pharmaceutical supervision, which till 1st January 1999 was subordinated in content-related and official aspects to National Pharmaceutical Inspector, the head of the National Pharmaceutical Supervision and Junior Minister in Ministry of Health and Social Care, and who was responsible for the drug policy. Subordination of provincial pharmaceutical inspectors to governors and at the same time, the new administrative territorial division of the country have caused an organizational change. Inspectorates of Pharmaceutical Supervision in provincial capitals become the Provincial Inspectorates of Pharmaceutical Inspection, and inspectorates, which were outside the provincial capitals, were transformed into representative offices, branches or out-of-city centers of the provincial pharmaceutical inspections subordinated to the Provincial Pharmaceutical Inspectors. The change of official subordination of the provincial pharmaceutical inspections did not influence the content-related subordination. The content-related superior of provincial pharmaceutical inspectors still is Main Pharmaceutical Inspector.

With the date of 1stJanuary 2000, Department of Pharmaceutical Inspection was separated from the structures of Ministry of Health, giving rise to a new institution - the Chief Pharmaceutical Inspectorate - the auxiliary country machinery of Chief Pharmaceutical Inspector, supporting him with performing of legal tasks. These changes were introduced by the Act of 24th July 1999 on changing the Act on government administration departments, as well as some other acts (Journal of Law No. 70 item 778).

The separation of the new central institution from Ministry of Health structures has caused competence division between Chief Pharmaceutical Inspector and Minister of Health. Currently  Pharmaceutical Inspection works based on Health Minister's Decree of 14th July 2009.