New laws have come into force regulating internet sales of non-prescription pharmaceuticals and introducing a new central database for the distribution of electronic prescriptions.
Czech law requires prescription pharmaceuticals to be dispensed by a qualified pharmacist who personally hands over the medicines and is available to consult with patients. This precludes distance selling of prescription pharmaceuticals, even those registered in the electronic prescriptions central database.
Only pharmacies meeting certain requirements (such as operating a face-to-face dispensary and keeping a database of all pharmaceuticals and prescriptions) can engage in distance selling, including over the internet. They must also make a declaration to the State Institute for Drug Control within 15 days of starting distance selling.
The Institute publishes information on its website (www.sukl.cz) about all registered pharmacies and those permitted to engage in distance selling. Any pharmacy which is not permitted to do so must inform the patient of this fact whenever it receives an order for distance selling.
As for online sales:
- they are limited to non-prescription pharmaceuticals
registered as medicinal products in the Czech Republic or in
another EU member state
- the pharmacist must guarantee that each order is
despatched within 48 hours and delivered to the patient
within 3 days following the order (or, within the same
period, notify the patient that this is not possible)
- online sales must be guaranteed to reach the patient in
the same quality as if sold in a pharmacy
- all information accompanying the pharmaceutical must be
in the language of the EU member state in which the patient
- the pharmacist must publish all relevant information
regarding distance sale, prices and the cost of
- patients ordering pharmaceuticals online must be able to
return them without cost, and any returns must be removed
from the market and treated as unusable
The legislation goes further than EU law in allowing pharmaceuticals to be sold not only to patients in other EU member states but to patients in any other country. However, limiting internet sales of non-prescription pharmaceuticals to pharmacies operating face-to-face dispensaries may be contrary to Article 28 of the ERC Treaty as it is a rule hindering free trade.
The legislation also permits distance selling of pharmaceuticals from another EU country to the Czech Republic, under certain conditions. This only applies to pharmaceuticals which are registered in a EU member state (including the Czech Republic) or are available without prescription in the Czech Republic (regardless of the position in the country from which they are sold) or comply with Czech or EU registration conditions for pharmaceuticals. Before engaging in distance selling, the person responsible for delivery of the pharmaceuticals must make a declaration to the Institute and prove that it is authorised to sell pharmaceuticals to the public in another EU state.
Law: Act No. 378/2007 on Pharmaceuticals
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The original publication date for this article was 08/07/2008.