Romania: Online pharmacies - a new benefit for the pharma business

Although Law 160/2018 granted pharmacies and drugstores the possibility to sell over-the-counter drugs (“OTCs”) in July of last year, the detailed regulations governing online sales are only now being finalised.

On 15 January, the Romanian Ministry of Health (“MoH”) held a meeting to discuss public observations to its draft Order for the approval of the Norms regarding the establishment, organisation and operation of the pharmaceutical units, including the online pharmacies, which was published on the MoH website in mid-December 2018 (“MoH 2019 Draft Norms”).

Of particular relevance to pharmacies / drugstores wishing to sell OTCs online, the MoH 2019 Draft Norms, in conjunction with applicable law, states:

→   In order to undertake online sales of OTCs, community pharmacies and drugstores must:

→   Applicants need to appoint a pharmacist responsible for the online sale and release of medicines, and include the pharmacist’s name in the notification to the MoH.

→   Applicants will be required to undergo an inspection by the MoH. The MoH will have 30 days from the inspection date to issue its decision granting/denying authorisation to sell online. Neither Law 160/2018 nor the MoH 2019 Draft Norms address procedures to challenge a decision of the authority rejecting the authorisation.  

→   Applicants exclusively dedicate at least 10 sq.m. to the functioning of the online service, featuring: furniture adequate for packaging and storing; equipment ensuring temperature and humidity monitoring; other means for storing the medicines in accordance with the producer’s specifications; computer and Internet connection. 

→   The pharmacy/drugstore’s website must comply with applicable e-commerce legislation and contain a page dedicated to the online business, with following minimum information:


→   Online sales are only permitted for patients over 18 years old.

→   The pharmacy/drugstore may outsource its website’s technical activity. Transportation can also be outsourced to contractors ensuring controlled temperature. Note however, the sale and release of medicines cannot be outsourced.