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Main Pharmaceutical Inspector:
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is the central institution of government administration executing tasks of the Pharmaceutical Inspection with means of the Main Pharmaceutical Inspectorate, |
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manages the Pharmaceutical Inspection, |
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is supervised by the proper minister in charge of health matters, |
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is appointed and dismissed by Prime Minister on application of the proper minister in charge of health matters, |
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is the appeal institution in matters connected with executing tasks and competences of Pharmaceutical Inspection (he is the institution of second instance with regard to decisions of the provincial pharmaceutical inspectors), |
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is the institution of the first instance in matters defined in the Act. |
The most important responsibilities resulting from the Pharmacy Law Act:
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he assigns priorities of activity of Pharmaceutical Inspection, |
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he co-ordinates and controls execution of the tasks by provincial pharmaceutical inspectors, |
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he may give instructions to the provincial pharmaceutical inspectors concerning specific activities in the scope of their content-related operations with restriction of tasks encompassed with giving administrative decisions, as the first instance, as also he can demand from the provincial pharmaceutical inspectors information on the whole range of Pharmaceutical Inspection's activity, |
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he holds supervision over production conditions of medicinal products administered to men and animals, |
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he co-operates with proper Pharmaceutical Inspections of other countries, including members of the European Union, |
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he prepares training programmes for Pharmaceutical Inspection's employees, |
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he holds supervision over obedience of the regulations of Pharmacy Law Act in the scope of advertisement, he can therefore, with the means of made decisions, order the cessation of medicinal product's advertisement if it is against the current regulations, and order the publication of the made decision in the places, where such advertisement had appeared, with the correction of the false commercial, |
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he gives decisions in the range of:
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Suspension or withdrawal from turnover or usage in institutions of health care, of the medicinal products in case of suspicion or assertion, that the given product is not admitted to turnover in Poland, |
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Suspension or withdrawal from turnover or usage in institutions of health care, of the medicinal products in case of suspicion or assertion, that the given product does not comply with the set individual quality requirements, |
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Suspension or withdrawal from public pharmacies or pharmaceutical warehouses of products, which turnover is prohibited, |
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Suspension of turnover in pharmaceutical warehouse, pharmacy, pharmacy outlet or in institutions outside the pharmacy turnover, which are mentioned in the Article 71 paragraph 1 items 1 to 4, or suspension of usage in institutions of health care of medicinal products in case of suspicion, that the given product does not comply with the set individual quality requirements, |
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granting of, changing, withdrawing or refusing of permissions for production of medicinal products, as well as wholesale turnover of medicinal products and medical articles |
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He secures running inspections of production and wholesale distribution in accordance with to uniform standard procedures of inspection, |
The most important tasks resulting from the Act on counteracting drug addiction:
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Giving permissions for production, processing or reprocessing of intoxicants or psychotropic substances, |
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Giving permissions for production, processing or reprocessing of precursors of the group I−R, |
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Giving permissions for import and export across border of intoxicants or psychotropic substances or precursors from the group I−R for each shipment into or out of the country, |
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Giving permissions to harvest poppy milk and opium from poppy, as well as from hemp herbs and resin of hemps permitted in the aim of running scientific research, |
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Giving permissions for wholesale turnover of intoxicants or psychotropic substances, as well as permission for wholesale turnover of precursors from the group I−R. |
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COMPETENCES OF MAIN PHARMACEUTICAL INSPECTOR
