NIS Considerations
CHCUK NewsletterDecember 2011
In this Month's Issue
Slovakia: New Clinical Trials Law




The focus this month is on the recent changes to the drug law through Act 362/2011 which have had a direct impact on the requirements for conducting NIS in the Slovak Republic.

The Act came into force on the 1 Dec 2011 ans is applicable to ALL NIS regardless of whether they were already in progress at the time of the Act coming into force.

Best wishes,

Stuart McCully
Tel: +44 (0) 1997 42 33 11
Mobile: +44 (0) 7909 111 510

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Slovakia: New Clinical Trials Law
Act 362/2011 Coll. comes into force on 1 Dec 2011 and includes some new requirements for non-interventional studies
Flag of Slovakia


The Slovak republic has adopted Commission directives 2001/20/EC and 2005/28/EC into Act
362/2011 Col. There are  some  differences in the procedures between Slovak Acts and these

As a result, Act 362/2011 Coll (on medicines and medical devices and amending certain laws repealed Act 140/1998 Coll on the 1st December 2011. 


Section 45 of the new act provide very specific guidance on the requirements for the conduct of non-interventional studies.


According to the guidance from State Institute for Drug Control (SIDC), the following NIS-related changes have been implemented through Act 362/2011 Coll:

Non-intervention clinical trials - (article 45)
  1. Definition was extended and includes a responsible person called "guarantee" (new)
  2. NIS should be approved by health insurance companies,  if the medicinal product is registered less than 2 years (new)
  3. The protocol and final report should be published on web-site of National Centre of Health Information (NCZI) (new) 

Articles of §45 of the Act 362/2011:


(1)  Basic definition of NIS.

(2)  Exact wording that in case of NIS:

a)a human drug is prescribed in accordance with the SPC (approved by market authorization)

b)the enrollment of a patient into the therapy is not given by Protocol in advance

c)a decision to prescribe a human drug should be distinguished from a decision to enrolled a patient into NIS

d)no additional diagnostic neither monitoring proceedings should be used

e)data should be analyzed by epidemiological methods

f)there is a person responsible for the study (scientific expert), requirements for this person are the same as for an investigator in clinical trials.

(3)  Requirements for clinical trials written in §29-§44 do not apply to NISs.

(4)  NIS can be performed only after a written consent of a subject´s health insurance company. This approval is based on the Protocol of NIS submitted by a scientific expert. The HI company will not agree with NIS if:

a)Protocol is not written according to the Article (5) of this Act,

b)it is more than 2 years from the registration of the drug in Slovakia,

c)requirements according to the Article (2) b) and c) were not fulfilled

(5)  Protocol of NIS contains:

a)name of NIS Sponsor

b)address of NIS Sponsor

c)title of NIS

d)aim of NIS

e)start and end date of NIS

f)name of a scientific expert

g)way of the results processing

h)date, form and period of the results publishing (it must be within 2 months from the end of the study)

i)fee for a scientific expert

(6)  Sponsor is obliged to send the Protocol approved by a subject´s HI company to National Health Information Center which publishes it on its website within 3 days.

(7)  Sponsor should send results of a non-interventional study to subject´s HI company and to National Health Information Center that publishes it on its website within 3 days.



  1. for a scientific expert if participated in NIS not done according to §45 of this Act: 200 - 10 000 EUR (sanction is defined in §136)
  2. for Sponsor if NIS is performed without the previous approval of subject´s HI company or if NIS results are not sent to HI company and National Health Information Center within 1 month after proceeding or if a NIS Protocol approved by a HI company is not sent to National Health Information Center: 500-25 000 EUR (sanction is defined in §138)

A sanction might be doubled in case of a repeated breach.

Specific Considerations:

Results must be published within  2 months from the end of the study (so the last patient last visit??). The only way this requirement makes sense in combination with the sanction is that results should be published (anywhere, but the form of publishing should be written in the Protocol) within 2 months from the last patient in the study and results must be sent to HI companies/NCHI within 1 month from the date of the final report, so Sponsor has one month for data proceedings and a final report preparation.  HI companies interpretation will be important - and will be clarified at the meeting of the association of pharma companies with health insurance companies regarding these studies in the week commencing 19th December 2011

For further information refer to: