Medicinal Products for Human use - Poland

The Clinical Trial Regulation (CTR) came into effect in January 2022 with a transition period until January 2025. With the implementation of the CTR, the processes for submission, assessment and supervision of clinical trials throughout the EU is harmonised through the Clinical Trial Information System (CTIS). It is now the single entry point for clinical trial data in the European Union. Learn more about its functionalities and how to use it on our CTIS page.
 
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Competent Authority

Submission Fees

Fees for trial submission mandatory
Yes
Fees

Phase I-III, commercial clinical trials

  • The Republic of Poland acts as a repporteur: 15 000 PLN (approx. 3 750 EUR)
  • The Republic of Poland does not act as a repporteur: 10 000 PLN (approx. 2 500 EUR)
  • based on Article. 14 of Regulation 536/2014: 10 000 PLN (approx. 2 500 EUR)

Phase IV

  • The Republic of Poland acts as a repporteur: 10 000 PLN (approx. 2 500 EUR)
  • The Republic of Poland does not act as a repporteur: 6 000 PLN (approx. 2 500 EUR)
  • based on Article. 14 of Regulation 536/2014: 6 000 PLN (approx. 1 500 EUR)

Non-commercial clinical trials

  • The Republic of Poland acts as a repporteur: 4 000 PLN (approx. 1 000 EUR)
  • The Republic of Poland does not act as a repporteur: 2 000 PLN (approx. 500 EUR)
  • based on Article. 14 of Regulation 536/2014: 2 000 PLN (approx. 500 EUR)
Waiver for academic (non-commercial) studies possible
Reduced fees are charged
Payment requirements (timelines)
Prior to submission of application
Official guidance on required fees available
Yes
Official guidance on required fees

Current fees are provided in English on the URPL website in section: Fees. (https://www.urpl.gov.pl/pl/op%C5%82aty)

National legal framework in place
Yes
Applicable national legal framework/reference

Act of 9 March 2023 on clinical trials of medicinal products for human use (Dz.U. 2023 poz. 605 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20230000605/O/D20230605.pdf)

Additional Information & Specifics

Additional Information & Specifics

President of the Office is a government administrative authority, competent for matters concerning marketing authorization of medicinal products and clinical trials – within the scope determined by the Act on Pharmaceutical Law of 6 September 2001 (Dz.U. 2001 nr 126 poz. 1381 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20011261381/U/D20011381Lj.pdf) 


The Office is a public administration body supporting the President of the Office in realization of the above matters.
The rules and the scope of responsibilities is determined by the Act of 18 March 2011 on the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (Dz.U. 2011 nr 82 poz. 451 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20110820451/U/D20110451Lj.pdf)

Ethics Committee

Submission Fees

Fees for ethical review mandatory
Yes
Waiver for academic (non-commercial) studies possible
Reduced fees are charged
Fees for ethical review

Phase I-III, commercial clinical trials

  • The Republic of Poland acts as a repporteur: 15 000 PLN (approx. 3 750 EUR)
  • The Republic of Poland does not act as a repporteur: 15 000 PLN (approx. 3 750 EUR)
  • based on Article. 14 of Regulation 536/2014: 15 000 PLN (approx. 3 750 EUR)

Phase IV

  • The Republic of Poland acts as a repporteur: 15 000 PLN (approx. 3 750 EUR)
  • The Republic of Poland does not act as a repporteur: 15 000 PLN (approx. 3 750 EUR)
  • based on Article. 14 of Regulation 536/2014: 15 000 PLN (approx. 3 750 EUR)

Non-commercial clinical trials

  • The Republic of Poland acts as a repporteur: 4 000 PLN (approx. 1 000 EUR)
  • The Republic of Poland does not act as a repporteur: 4 000 PLN (approx. 1 000 EUR)
  • based on Article. 14 of Regulation 536/2014: 4 000 PLN (approx. 1 000 EUR)
Official guidance on required fees available
Yes
Official guidance on required fees

Current fees are provided in English on the Supreme Bioethics Committee website in section: For sponsors. (https://nkb.gov.pl/?serwis=sbc&dzial=for-sponsors/application-fees&id=233)

National legal framework in place
Yes
Applicable national legal framework/reference

Act of 9 March 2023 on clinical trials of medicinal products for human use (Dz.U. 2023 poz. 605 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20230000605/O/D20230605.pdf)

Additional information

Additional Information & Specifics

Additional Information & Specifics

Study Specific Requirements

Standard IC form (ICF) available
Not specified
Standard IC form (ICF)
Standard ICF - Additional Information
IC is regulated by law
Yes
Informed Consent - Definition/ Requirements

Definition in accordance with Regulation 526/2013. Prior to the commencement of a clinical trial, informed consent must be obtained from study subjects. Informed consent means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical trial, after having been informed of all aspects of the clinical trial that are relevant to the subject's decision to participate or, in case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical trial.

National legal framework in place
Yes
Applicable national legal framework/ Reference

Act of 9 March 2023 on clinical trials of medicinal products for human use (Dz.U. 2023 poz. 605 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20230000605/O/D20230605.pdf)

Act of 5 December 1996 on proffesion's of physician and dentis, Article 25 (Dz.U. 1997 nr 28 poz. 152 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU19970280152/U/D19970152Lj.pdf )

Additional Information

Study participants - vulnerable population

Minors / Children - Studies allowed
Yes
Special provisions apply
Specific provision
Legal Act (for editing - no possibility of entering longer text)
Legal framework/Reference (Minors/Children)

Act of 5 December 1996 on proffesion's of physician and dentis, Article 25 (Dz.U. 1997 nr 28 poz. 152 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU19970280152/U/D19970152Lj.pdf )

Incapacitated persons - Studies allowed
Yes
Special provisions apply
Specific provisions

It is prohibited to conduct a research experiment on an incapacitated person. The consent of a person who is completely incapacitated to participate in a therapeutic experiment shall be given by his or her legal guardian. If the totally incapacitated person has sufficient understanding, his or her consent shall also be required.

Legal framework / Reference (Incapacitated persons)

Act of 5 December 1996 on proffesion's of physician and dentis, Article 25 (Dz.U. 1997 nr 28 poz. 152 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU19970280152/U/D19970152Lj.pdf )

Emergency situations - Studies allowed
No national legal framework available
Specific provisions
Emergency situation without prior consent of patient or proxy - Studies allowed
Yes
Special provisions apply
Conditions allowing trial participation in emergency setting without prior consent

In the case of a participant who is a person with full legal capacity but lacking the ability of mental judgement to give consent, authorisation to conduct the therapeutic experiment shall be given by the guardianship court with territorial jurisdiction in the area where the experiment is to be conducted.

Legal framework / Reference (Emergency Situation)
Act of 5 December 1996 on proffesion's of physician and dentis, Article 25 (Dz.U. 1997 nr 28 poz. 152)
Pregnant or breastfeeding women - Studies allowed
No national legal framework available
Specific provisions
Legal framework / Reference (Pregnant or breastfeeding women)

Study participants - compensation & reimbursement

Reimbursement for study participants
Optional
Compensation is limited to/provided for
Expenses arising from study participation (e.g. Travel)
Additional Information

No specific provisions in national legislation

Data protection

Notification to DP Authority/ Ombudsmann is mandatory
No
Approval/authorisation required
No
Specific notification timelines before operations start
Not applicable
Laguage of notification
Not applicable
Notification format
Not applicable
Notification fee required
No
Fee
Guidance on notification requirements available
No
Guidance on notification requirements
Data protection authority/agency - contact details

The President of the Personal Data Protection Office

Contact name 2
Robert Miętkowski - the Data Protection Officer (iod@uodo.gov.pl)
Contact name 3
Phone
+48 22 532 82 50
Fax
E-mail
kancelaria@uodo.gov.pl
Address
ul. Stawki 2, 00-193 Warszawa
ZIP/City
00-193 Warszawa
Country
Poland
Additional information

Insurance

Liability insurance or alternative arrangements for damages mandatory for
Investigator(s)
Sponsor
Responsible for covering insurance
Sponsor
Isurance fee: a minimum coverage sum is defined
Yes
Minimim coverage sum

The minimum guarantee sum of civil liability insurance,  depends on the number of participants in the clinical trial and is the equivalent in PLN of:

  • up to 50 participants - EUR 2,000,000;
  • over 50 persons - 5,000,000 euros.
National legal framework/reference
Yes
Applicable national legal framework/reference

Act of 9 March 2023 on clinical trials of medicinal products for human use (Dz.U. 2023 poz. 605 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20230000605/O/D20230605.pdf)

Additional information

National legislations

General Information

Official governmental legal database available
Yes
Official governmental legal database

ISAP (Internetowy System Aktów Prawnych, ang. The Internet System of Legal Acts), Online Database system of legal acts containing bibliographic and legal texts published in official publications (the Journal of Laws and the Polish Monitor) issued by the Prime Minister - https://isap.sejm.gov.pl/

Additional information

Clinical trials on IMPs in Humans

Applicable national regulations
General Act(s) on Medical/Clinical Research in Humans

Radiation & Radiotherapy

Specific framework available
Yes
Applicable legal framework

Regulation of the Minister of Health of 11 January 2023 on the conditions for the safe use of ionising radiation for all types of medical exposure (Dz.U. 2023 poz. 195 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20230000195/O/D20230195.pdf)
Act of 29 November 2000 on Nuclear Law (Dz.U. 2001 nr 3 poz. 18 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20010030018/U/D20010018Lj.pdf)
Act of 6 September 2001 on Pharmaceutical Law (Dz.U. 2001 nr 126 poz. 1381 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20011261381/U/D20011381Lj.pdf)

Additional information

Biobanking

Specific framework available
No
Applicable legal framework
Additional information

Additional Information & Specifics

Additional Information & Specifics

Definitions

Observational study

Observational study - Definition available in national law
No
Observational study - Definition

Academic sponsors

Academic Sponsors - Definition available in national law
Yes
Academic Sponsors - Definition

Based  on the Act of 9 March 2023 on clinical trials of medicinal products for human use (Dz.U. 2023 poz. 605 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20230000605/O/D20230605.pdf), the Sponsor or co-sponsor of clinical trials is:

  • an entity reffered to in Article 7 of the Act of 20 July 2018 - Law on Hihger education and Science (Dz.U. 2022 poz. 574 -https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20180001668/U/D20181668Lj.pdf), or
  • an therapeutic entity reffered to in Article 4(1) of the Act of 15 April 2011 on therapeutic activity (Dz.U. 2022 poz. 633 - https://isap.sejm.gov.pl/isap.nsf/download.xsp/WDU20111120654/U/D20110654Lj.pdf), or
  • Investigator, or
  • an association whose statutory objective is to protect patients' rights, or
  • an association which is, in accordance with the provisions of its statutes, a scientific society of national scope, associating specialists in the relevant field of medicine, the field of nursing or the field of obstetrics, or
  • a legal person or an organisational entity other than those referred to in points (a) to (e) whose purpose is not to make a profit by conducting and organising clinical trials or by manufacturing or marketing medicinal products.