- Michalopoulou & Associates
In the last few years, there has been an alarming increase of falsified medicinal products in Europe. Falsified medicines are medicines with a false representation of their identity, source and history -medicines therefore which pass themselves as real, authorized medicines. In particular, falsified medicines might contain ingredients which are of bad quality or in wrong dosage. For these reasons they are a major threat to public threat and safety.
The legal framework regarding falsified medicines is set out in Directive 2011/62/EC which amended Directive 2001/83/EC relating to medicinal products for human use, as regards to the prevention of entry chain of falsified medicinal products into the legal supply. In order to prevent the circulation of falsified medicines, the newest Directive foresees the establishment of a common logo which will be clearly displayed on every page of the website which offers online sale of medicinal products (online pharmacies/retailers). Further on, the Directive states that implementing measures should be conferred on the Commission regarding the common logo’s design and requirements.
In this context, the European Commission adopted the new common logo by implementing Regulation No 699/2014 which determines its design and special requirements in order to be displayed on all online pharmacies or retailers which are legally operating within the EU. The Regulation will apply from July the 1st 2015, binding all Member-States.
How does the logo work?
The logo will be displayed on the primary page of the website of an online pharmacy and will bear the flag of the Member-State where the pharmacy or retailer is registered or authorized. Every user accessing the website will be redirected to the website of the national competent authority listing all legally operating online pharmacies/retailers. In this way, the purchaser will be able to verify if the medicinal products offered are authentic by being able to check first-hand the registration of the pharmacy to the national list. The logo can be therefore trusted only if a purchaser, after clicking, is redirected to the entry of that pharmacy on the list of legally operating on-line pharmacies and retailers registered in that Member State on the national authority’s web-page.
Our law firm’s comment:
The sale of falsified medicines is a major threat towards public health and security and should therefore be efficiently confronted. As a result, we consider that the implementation of a common logo by all Member-States will sufficiently contribute to solving the problem. Relevant EOF guidelines/circulars regarding the adoption/implementation of the common logo by online pharmacies and retailers in the upcoming months are anticipated, as well as relevant measures regarding informing the general public.