CLV Partners


Pharmaceutical news – February 2015

From 1 February 2015 the Decree No. 3 of 2009 (Febr. 25) of the Minister of Health on detailed regulations regarding promotion of medicines for human use and therapeutic medical devices, registration of promotional representatives, commercial practices regarding medicines, therapeutic medical devices against consumers („Decree”) is amended. In the present Newsletter we summarize the amending provisions of the Decree.
I. Amending provisions regarding the qualification of promotional representatives

According to the transformation of higher education system, the provision defining the requirements of promotional representatives’ quilification is amended, based on which ,instead of the medical college degree, the Decree requires BA degree – detailed below – of any discipline of medicinal or health science training or any branch of health science training, naturally in addition to the qualification of doctor, dentist, pharmacist and chemist.

II. Amendment of regulations of providing free allocation of medicinal samples

The regulations on providing the free pharmaceutical samples are amended and from 1 February not only the promotional representative during its promotion may provide free medicinal samples to the HCPs, but the wholesaler are also entitled to deliver the samples.

The wholesalers shall also record the handover of the free sample.The content elements are not affected by this amendment.
In case of health-care provider the wholesaler shall hand over medicinal samples to the chief pharmatist and shall hand over one copy of the record.

Should you have any further queries in connection with the amendments above, we are pleased to assist you.
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