|
The most important tasks of the state pharmaceutical inspection result from:
| 1. |
Pharmacy Law Act of 6th September 2001 (Journal of Law of 2004 No. 53, item 533, No. 69, item 625, No. 91, item 877, No. 92, item 822, No. 93, item 896 and No. 173, item 1808), in particular from the chapter 8 - Pharmaceutical Inspection, |
| 2. |
Act of 24th April 1977 on Counteracting drug addiction (i.e. Journal of Law No. 24, item 198 of 13th February 2003) |
Regarding 1. Pursuant to Article 108 paragraph 1 of the Pharmacy Law Act, Pharmaceutical Inspection holds supervision over all conditions of production of medicinal products (whereas in the case of conditions of production in factories producing veterinary medicinal products supervision is held by Pharmaceutical Inspection with co-operation of Veterinary Inspection), as well as over quality and turnover of medical articles and medicinal products, in order to protect social business in the scope of safety of health and life of citizens using medical articles and medicinal products, available in pharmaceutical wholesalers, pharmacies, pharmacy outlets and institutions of turnover out of pharmacies.
Article 108 paragraph 4 points out the decisions made by the Institutions of Pharmaceutical Inspection.
The Decisions cover the following scope:
| 1. |
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, |
| 2. |
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, |
| 3. |
Suspension or withdrawal from public pharmacies or pharmaceutical warehouses of products, which turnover is prohibited, |
| 4. |
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, |
| 5. |
granting of, changing, withdrawing or refusing of permissions for:
| a) |
running a pharmacy, |
| b) |
production of medicinal products, |
| c) |
wholesale turnover of medicinal products and medical articles. |
|
| 6. |
referring of medicinal products, admitted to turnover on territory of Republic of Poland to qualitative tests. |
Article 109. The tasks of Pharmaceutical Inspection are in particular:
| 1. |
controlling the conditions of production of medicinal products as well as conditions of transport, reloading and storage of medicinal products and medical articles, |
| 2. |
holding the supervision over quality of medicinal products and medical articles, which are the object of turnover, |
| 3. |
control over pharmacies and other individuals carrying the retail turnover and wholesale turnover of medicinal products and medical articles, |
| 4. |
controlling the quality of prescription medicines and pharmaceuticals prepared in pharmacies, |
| 5. |
controlling proper labeling and advertising of medicinal products, as well as the proper labeling of medical articles, |
| 6. |
controlling the turnover of the intoxicants, psychotropic substances and precursors of group I−R, |
| 7. |
co-operation with the specialized team of consultants in charge of pharmacy, |
| 8. |
giving opinions on usefulness of remises designed for a pharmacy or warehouse as well as for outlet outside pharmacy turnover, |
| 9. |
co-operation with pharmacists' council and other councils, |
| 10. |
keeping a register of public and hospital pharmacies, as well as of pharmacy outlets, |
| 11. |
keeping Register of Pharmaceutical Wholesalers, as well as Pharmaceutical Factories, |
| 12. |
giving opinions concerning pharmacies, in which it is possible to receive a training. |
Regarding 2. The basic tasks of Main Pharmaceutical Inspector resulting from the regulations of the Act on counteracting drug addiction are as follows:
| 1. |
Giving permissions for:
| a) |
wholesale turnover of intoxicants or psychotropic substances (article 27 paragraph 1) |
| b) |
wholesale turnover of precursors of the group I−R (article 27 paragraph 2) |
|
| 2. |
Giving permissions for:
| a) |
production, processing or reprocessing of intoxicants or psychotropic substances (article 23 paragraph 1), |
| b) |
production, processing or reprocessing of precursors of the group I−R (article 23 paragraph 2), |
| c) |
production, processing or reprocessing of intoxicants from the groups I−N, II−N, IV−N or psychotropic substances from the group I−P, II−P, III−P or precursors of the group I−R (article 23 paragraph 3), with the aim of running scientific research exclusively for colleges, research and development units or other scientific institutions in the scope of their statutory activity, |
| d) |
use of intoxicants group IV−N or psychotropic substances from group I-P (article 23 paragraph 8), with the aim of running scientific research exclusively for colleges, research and development units or other scientific institutions in the scope of their statutory activity, |
| e) |
harvest of poppy milk and opium from poppy, as well as from hemp herbs and resin of hemps (article 24 paragraph 1) |
|
| 3. |
Giving permissions for import and export:
| a) |
permits for import and export across border of intoxicants or psychotropic substances or precursors from the group I−R (article 25 paragraphs 2 and 3 in connection with paragraph 1) |
| b) |
permits for import from abroad and export abroad of poppy straw (article 25 paragraph 5) |
| c) |
permits for import from abroad and export abroad for own therapeutic needs of medicinal products containing intoxicants and psychotropic substances. |
|
Main Pharmaceutical Inspector in own activities concerned supervision over turnover of intoxicants and psychotropic substances follows also the regulations of Uniform convention about intoxicants of 1961 (Journal of Law No. 45, item 277 with further changes), Convention about psychotropic substances of 1971 (Journal of Law No. 31, item 180 of 1976) and convention of Nations United about fighting the illegal turnover of intoxicants and psychotropic substances of 1988 (Journal of Law No. 15, item 69 of 1995).
The basic tasks resulting from regulations of the above conventions are:
| 1. |
Working out quarterly reports for INCB (International Narcotics Control Board) concerning the turnover of intoxicants and psychotropic substances. |
| 3. |
Working out annual reports for INCB (International Narcotics Control Board) concerning the turnover of intoxicants, psychotropic substances and precursors of group I-R. |
| 3. |
Co-operation with government and nongovernmental organizations and also with the Police and institutions of customs control. |
|
TASKS OF THE STATE PHARMACEUTICAL INSPECTION
