August 2018 – The online sale of pharmaceutical products in Romania has been on the rise in recent years. This strengthening trend can be attributed to the growth of online purchases in Romania in general and to the fact that, until recently, the law left room for interpretation in this area.
Recent amendments to the laws governing the sale of pharmaceuticals in Romania have been adopted in relation to the online sale of pharmaceutical products (the "Online Pharmacy Law") that set out clearly the conditions under which entities are allowed to sell medicinal products using online means in Romania and the requirements that these entities have to meet in this respect.
The Online Pharmacy Law brings the following main relevant changes to existing legislation:
- Who can sell online? The only entities allowed to sell non-prescription medicinal products using online means are pharmacies and the drugstores authorised by law to do so; the specific conditions for online sales are specified by secondary legislation adopted by the Ministry of Health.
- How can they sell online? Authorised pharmacies and drugstores that intend to sell medicinal products using online means must notify the Ministry of Health of their intention.
- Registry of authorised entities: The Ministry of Health's website will include a list of the legal entities authorised to sell non-prescription medicines using online means.
- Information to be provided to
customers: The following information must be published on
the website where the non-prescription medicinal products are sold:
- o contact details of the Ministry of Health;
- o hyperlink to the Ministry of Health's website;
- o the European common logo for the sale and release of medicines;
- Sanctions: Companies that fail to comply with the provisions of the Online Pharmacy Law or that engage in activities as wholesalers in medicinal products may be sanctioned by the Ministry of Health with a fine between EUR 10,000 and EUR 22,000.
This Online Pharmacy Law harmonises Romanian law with EU Directive 2011/62/UE on the prevention of the entry into the legal supply chain of falsified medicinal products.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.