Notification by the Ministry of Health of the Slovak Republic on the reporting obligation of pharmaceutical companies valid from 27.3.2018
Pursuant to § 74a of Act No. 362/2011 Coll. on medicinal products and medical devices and amending certain laws as amended (hereinafter referred to as "the Act') the pharmaceutical company is required to communicate to the Ministry of Health of the Slovak Republic (hereinafter referred to as "the Ministry') the following information: The pharmaceutical company is required to submit to the Ministry, no later than the last day of the following calendar month, a report on the medical meetings for the previous calendar month.
Reporting to the pharmaceutical companyneeds to be filled in through the URL.
(URL can be obtained on request. Contact: PharmDr. Dominik Cesnek,dominik.cesnek@health.gov.sk)
The pharmaceutical company is required to notify the Ministry of Health of the details within the meaning of § 74a, paragraph 3 and paragraph 5 of the Act:
- before the start of its activities
- without delay when changing the particulars of the pharmaceutical company
Monthly report on medical meetingsfor the previous calendar month it is necessary to fill in via the URL.
(URL can be obtained on request. Contact: PharmDr. Dominik Cesnek,dominik.cesnek@health.gov.sk)
The pharmaceutical company is obliged to notify the Ministry of Health of the details of medical meetings for the previous calendar month within the meaning of Paragraph 74a (5) of the Act:
- no later than the last day of the following calendar month
The last day of the following calendar month the data in the table will be considered definitive for the period and published on the website of the Ministry of Health.
Contact details of pharmaceutical companies are published on our website. We ask you to check Your data.
In case of any changes we ask you to report to email addressdominik.cesnek@health.gov.sk.
Pursuant to Paragraph 138 (26) of the Act, a pharmaceutical company commits another administrative offence if it fails to notify the Ministry of its activities, states incomplete or false information in the notification to the Ministry, does not immediately notify the Ministry of the change of data pursuant to Paragraph 74a (3) and does not submit a report on medical meetings to the Ministry pursuant to Paragraph 74a (6). The Ministry shall impose a fine pursuant to Paragraph 138 (27) of the Act on other administrative offences ranging from EUR 500 to EUR 25 000.
DATABAZA Pharmaceutical Companies - Contact Persons