In Romania, the online sale of over-the-counter medicines by pharmacies is regulated as of 2019. The pharmaceutical sector being in question, the regulations on the authorisation of online pharmacies are very strict, and legal procedures can oftentimes create difficulties when it comes to the documentation required to authorise an online pharmacy.
According to Romanian law, an online pharmacy is a pharmaceutical establishment authorised to online sell and dispense only over-the-counter medicines. At the same time, the law states that online pharmacies are prohibited from selling prescription medicines.
Authorisation of the online pharmacy is granted by the county public health directorate, subject to the fulfilment of all legal conditions and on the basis of supporting documentation.
Obtaining authorisation for online pharmacy in Romania
First of all, it should be specified that the online pharmacy will not be able to legally operate on the territory of Romania without the appointment of a pharmacist responsible for the online sale of over-the-counter medicines.
1.Conditions regarding the premises
The space allocated to the operation of the online pharmacy in Romania must be at least 10 sqm. It is necessary to mention that if the online pharmacy operates in the same place as the physical pharmacy, the space allocated to the online pharmacy must be additional to that required for the operation of the physical pharmacy.
In addition, the online pharmacy space must be equipped with specific equipment as required by the applicable legislation.
2.Conditions regarding the online pharmacy website
In addition to mandatory regulations on the online sale of products in Romania, the website of the online pharmacy in Romania must contain, among other elements, the following:
a) The possibility for the patient to have access to a private space, entitled “My Account”, which will include information on previous orders as well as communications with the pharmacist in charge of the online pharmacy activity and which will also contain a questionnaire in which the patient indicates date of birth, weight, height, gender, current treatments, history of allergies, pregnancy or breastfeeding status;
b) Hyperlinks to the websites of the Romanian Ministry of Health and the Romanian National Authority for Medicines and Medical Devices;
c) Information on the operating authorisation of the online pharmacy;
d) Declaration of consent to the processing of personal data, to be completed by each patient;
Among the other obligations regarding the online pharmacy’s website, we mention that it must be written in Romanian language, but it can be translated into other languages as well. The website will also be designed in such a way that the sale of medicines will only be possible after a prior interactive exchange between patient and pharmacist. The dialogue can be conducted by e-mail or through the online pharmacy website.
3.Conditions regarding the medicine sold
In addition to providing information on product description and complying with labelling regulations, the following will be displayed for each medicine offered for online sale in Romania:
b) Therapeutic indications from the marketing authorisation;
e) Classification according to the category to which the medical product belongs, in alphabetical order and without any highlighting.
The fines for failure to comply with the conditions for the establishment and operation of online pharmacies in Romania range from 20,000 to 50,000 lei, respectively 50,000 to 100,000 lei for repeated violation of the legal provisions, including the possibility of applying the sanction of cancellation of the operating license of the pharmaceutical unit.
The bnt attorneys in CEE team is at your disposal for any information on setting up, obtaining authorisations and operating online pharmacies in Romania as well as in other countries where bnt attorneys in CEE is present.