Main page Organisation Chart GMP Inspectors GMP Certificates Q & A Manufactures/ Importers Scope of activities Polska wersja

 The State Pharmaceutical Inspection, hereinafter referred to as "the Pharmaceutical Inspection", shall supervise:

1)   conditions of manufacturing and import of medicinal products and of veterinary medicinal products,

2)   quality and trade in medicinal products, except for of veterinary medicinal products,

3)   trade in medical devices, except for of medical devices used in veterinary medicine

– to protect social interests with respect to the safety of health and life of humans when using medicinal products and medical devices found in pharmaceutical wholesale stores, pharmacies, hospital pharmacy departments, pharmacy outlets and points of out-of-pharmacy sale.

2. (repealed).

3. (repealed).

4. The Pharmaceutical Inspection bodies shall issue decisions:

1)   to suspend trade in or to recall from the market or to withdraw from use in healthcare establishments medicinal products in the case of suspicion or establishing that the product concerned is not authorised for marketing in Poland;

2)   to suspend trade in or to recall from the market or withdraw from use in healthcare establishments medicinal products in the case of suspicion or establishing that the product concerned does not meet the quality requirements established for it;

3)   to suspend trade in or to withdraw from generally accessible pharmacies the goods which are subject to prohibition of trade;

4)   to grant, make a variation to, cancel or refuse to grant an authorisation:

a)   for operating a pharmacy,

b)   for medicinal product manufacturing,

c)   for wholesale trade in medicinal products,

5)   referring to quality tests a medicinal product authorised for marketing in the territory of the Republic of Poland.

6)   (repealed);

7)   advertising:

a)   of medicinal products,

b)   of operations of pharmacies and pharmacy outlets.

The tasks of the Pharmaceutical Inspection shall include in particular:

1)   inspecting the conditions of manufacturing and import of medicinal products in accordance with the Good Manufacturing Practice requirements referred to in Article 39 (4) and the data defined in Article 10 (2) (1) – (3), (12), (13) and (15);

1a) controlling the conditions of transport, reloading and storage of medicinal products and medical devices;

2)   supervising the quality of marketed medicinal products;

3)   controlling pharmacies and other institutions carrying out retail and wholesale trade in medicinal products and medical devices referred to in Article 108 (1);

4)   controlling the quality of magistral and officinal formulas prepared in pharmacies;

5)   controlling the correct labelling and advertising of medicinal products and correct labelling of medical devices;

6)   controlling the trade in narcotic agents, psychotropic substances, and precursors of group I-R;

7)   cooperation with the specialised team of pharmacy consultants;

8)   giving opinions on suitability of the premises intended to house a pharmacy or a wholesale store, or a point of out-of-pharmacy sale;

9)   cooperation with the pharmacists’ self-government and with other self-governments;

10) keeping the register of generally accessible and hospital pharmacies and of pharmacy outlets;

11) keeping the Register of Pharmaceutical Wholesale Stores and Pharmaceutical Manufacturing Sites;

12) giving opinions on pharmacies where initial on-the-job training can be conducted.

 

 

PIC/S EMA WHO