Legal Acts

The role of applicable law is to guarantee greater safety associated with the use of medicinal products. The law with regard to pharmacovigilance monitoring is subject to constant change, which results from the need for maintaining health and patients’ life and is associated with the development of new medical technologies. Provision of law shall guarantee the safety of medicinal products available on the market, and the occurrence of the possible risk that is associated with their application is properly monitoring and minimized. Below are the most important Polish legislative instruments in the field of pharmacovigilance.

Polish legal acts are as follow:

1. The Polish Physician’s and Dentist’s Profession Act of December 5, 1996 Dz.U. of 1997 No. 28 item 152.

2. Pharmaceutical Chambers Act Dz.U. of 1991 No. 41 item 179

3. The Nurses and Midwives Act Dz.U. of 2011 No. 174 iem 1039

4. Pharmaceutical Law of September 6, 2001 Dz.U. No. 126, item 1381.

5. Preventing and Combating Infections and Infectious Diseases Among People Act Dz. U. 2008 No. 234 item 1570 with implementing act – Regulation of the Minister of Health of December 21, 2010 on the undesirable postvaccinal reactions and the criteria for recognizing them Dz.U. of 2010 No. 254 item 1711