Abstract

Abstract The present work is aimed to answer a very interesting and sensitive legal issue in the Romanian pharmaceutical field. This issues regard mainly the existence of coordination or contradiction between Romanian (i.e. Romanian Pharmacy Law no. 266/20081) and European legislation (art 34 TFEU2) in respect of the delivery of the online sale of OTC medicine only from pharmaceutical units.

Highlights

  • This paper analysis the legal matter of online sale of over the counter medicine (OTC)3 through pharmaceutical units located in Romania

  • By reference to the provisions of the above-mentioned Article 85c paragraph 1 of Directive 83 and Article 21 paragraphs (1) and (2) of the Pharmacy Law, it appears that the Romanian legislator included an additional prerequisite for the online sale of medicines, namely the notice regarding the pharmacy's intention to sell and dispense medicines online to be submitted with the competent authority (i.e. Ministry of Healthy) prior to performing such activity shall contain, among other information, the address of the pharmaceutical unit from where the medicinal products are delivered to the consumer

  • The Romanian legislator invoked, among others, the following relevant reasons in justify the necessity to sell OTCs online only through pharmacies/ drug stores established under the Pharmacy Law: a.) the risks to which people who opt for medicines bought online are exposed are extremely high; b.) the Pharmacy Law was imposing a number of extremely restrictive conditions on how pharmacies operate and how medicines are sold, but failed to expressly prohibit online sale thereof by those who have no experience in the field

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Summary

Introduction

This paper analysis the legal matter of online sale of over the counter medicine (OTC)3 through pharmaceutical units located in Romania.

Results
Conclusion

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