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VOIVODESHIP PHARMACEUTICAL INSPECTOR

02.12.2015 22:23

[Секція 1. Економіка, організація і управління підприємствами, галузями, комплексами]

Автор: Stych Marek, PhD, Jan Długosz University in Czestochowa, Poland


Abstract

The article discusses issues concerning the functioning of the Voivodeship Pharmaceutical Inspector (Article 116 of the Pharmaceutical Act). It is an important body functioning within the administrative structure of the State Pharmaceutical Inspection. The matter will be referred to selected aspects concerning the functioning of that body, such as: legal basis, nomination procedure, and tasks.

Keywords: pharmace law, health safety of citizens, medicines

  

Legal basis

The Voivodeship Pharmaceutical Inspector and its auxiliary apparatus act pursuant to several statutory acts:

 the Pharmaceutical Act of 6 September 2001 ,

 the Act of 26 May 2010 on medical devices  ,

 the Act of 29 July 2005 on prevention of drug abuse ,

 the Act of 23 January 2009 on the voivode and government administration in the voivodeship ,

 the Public Finances Act of 27 August 2009 .

Pursuant to the Pharmaceutical Act and the Act on the voivode and government administration in the voivodeship, competent organs issue the following local law acts:

 voivodeship office statute  - issued by the voivode,

 Organizational Regulations of the Voivodeship Pharmaceutical Inspectorate.




Legal status

 The State Pharmaceutical Inspection supervises the quality and trade  in:

 medicinal products – the Pharmaceutical Act,

 medical devices - the Act on medical devices.

The main aim of the supervision and control is to ensure public health safety. It concerns mainly the application of medicinal products and medical devices legally authorised for marketing in Poland in pharmaceutical wholesale and retail markets, including pharmacies, “limited service pharmacies” (located in villages and not authorised to sell certain strong medicines), and non-pharmacy outlets. A relevant element of the Polish regulations is the voivodeship-level organ and its auxiliary apparatus :

Voivodeship Pharmaceutical Inspectorate – an auxiliary apparatus of the organ ; it acts pursuant to the Organizational Regulations of the Voivodeship Pharmaceutical Inspectorate ;

Voivodeship Pharmaceutical Inspector – an organ of the State Pharmaceutical Inspection. 

Under the provisions of the Pharmaceutical Act, the organ performs tasks of voivodeship combined administration on behalf of a given voivode. At the same time, the Voivodeship Pharmaceutical Inspector remains subordinate to the voivode. As it has already been said, the auxiliary apparatus of the Inspector is the Voivodeship Pharmaceutical Inspectorate. 

Article 113 of the Pharmaceutical Act stipulates the nomination procedure of the Voivodeship Pharmaceutical Inspector. They are appointed and dismissed by particular voivodes. The nomination takes the form of a special act. It is a unilateral activity which has a twofold legal effect:

 an authorisation to perform the function of Voivodeship Pharmaceutical Inspector

 employment.

The candidates for the Inspector are selected through competition, which is stipulated by the regulation of the Minister of Health of 25 June 2002 on the principles and procedures of the competition designed to select a candidate for voivodeship pharmaceutical inspector.  The regulation is based on Article 113 Paragraph 2 of the act. It stipulates the following issues:

 notice of competition,

 appointment of competition committee,

 competition proceedings.

The notice of competition is a statutory condition. It should precede the act of nomination. Otherwise, nomination is invalid. The act of nomination always requires written form. Another statutory condition is “approval from the Main Pharmaceutical Inspector”, which must be stated before the act of nomination is issued (Article 113 Paragraph 1 of the Pharmaceutical Act).




Acts

the Pharmaceutical Act of 6 September 2001 (J. of L. of  2008, no 45, item 271)

the Act of 26 May 2010 on medical devices (J. of L. of 2015, item 876)

the Act of 29 July 2005 on prevention of drug abuse  (J. of L. of 2012, item 124)

the Act of 23 January 2009 on the voivode and government administration in the voivodeship (J. of L. of 2015, item 525)

the Public Finances Act of 27 August 2009 (J. of L. of 2013, item 885)

the Regulation of the Minister of Health of 25 June 2002 on the principles and procedures of the competition designed to select a candidate for voivodeship pharmaceutical inspector (J. of L. no 113, item 989)

Annex to the Ordinance no 4/2015 of Podkarpackie Voivodeship Pharmaceutical Inspector containing Organizational Regulations of the Voivodeship Pharmaceutical Inspectorate in Rzeszow (approved by the Voivode of Podkarpackie on 22 September 2015)




Voivodeship Pharmaceutical Inspector's tasks

The Inspector performs the tasks of Pharmaceutical Inspection on behalf of a given voivode. It is an organ of the first instance as regards the matters concerning the State Pharmaceutical Inspection's tasks. As regards the most important issues, the Inspector:

 represents the Voivodeship Pharmaceutical Inspectorate before other organs and entities,

 manages a given Voivodeship Inspectorate,

 bears responsibility for the functioning of the body.

As regards some exemplary competences, the Voivodeship Pharmaceutical Inspector:

1. issues administrative decisions or resolutions concerning:

- withdrawal of medicinal products from the market or health care units if they might not be or have not been approved for marketing in Poland ,

- withdrawal of prohibited products from pharmacies and pharmaceutical warehouses,

- granting, changing, refusing to grant, or revoking permissions to run a pharmacy and “a limited service pharmacy”,

- advertising of pharmacies and “limited service pharmacies” ,

- assessment of premisses intended for pharmacies, “limited service pharmacies”, pharmaceutical warehouses, consignment warehouses, transshipment chambers, and non-pharmacy outlets.




Conclusions

The provisions of the Pharmaceutical Act concerning the Voivodeship Pharmaceutical Inspector should receive positive assessment. They guarantee accurate supervision and control over all the places where medicinal products can be sold. Another relevant issue stipulated by the Act is cooperation between the Inspection and its counterparts in the EU states. The cooperation guarantees that only legally authorised medicinal products and medical devices can be marketed. All attempts to merge the State Pharmaceutical Inspection with other similar structures is inadvisable as it may have a negative impact on the supervision over pharmacies and “limited service pharmacies”.




The list of references:

1. Ogiegło L. (ed.) Prawo farmaceutyczne, C.H. Beck, Warszawa 2010

2. Stych M., Państwowa Inspekcja Farmaceutyczna, Edytor.org, Tczew-Częstochowa 2013

3. Stych M., Administracyjnoprawne zagadnienia kontroli leków roślinnych [in:] Płonka-Syroka B., Syroka A., Sudol K. (ed.), Lek roślinny. Fitoterapia w medycynie klinicznej w dawnej tradycji leczniczej i we współczesnej kulturze popularnej. Zagadnienia teoretyczne i praktyczne, vol. III, Wrocław 2014 

4. Świerczyński M., Reklama produktów leczniczych według znowelizowanej ustawy – Prawo farmaceutyczne, Monitor Prawniczy 2003, no 10




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