Sample of Common European Logo for On-line Pharmacy from UK

From 1st July 2015 License is Required for On-line Sales of Medicinal Products in EU

If you are an online seller of medicinal products in EU, then you are directly affected by the EU Falsified Medicinal Products Directive 2011/62/EU.

From 1st July 2015, all online pharmacies or retailers of medicines legally operating in the European Union should display a new logo introduced by the Directive 2011/62/EU. Click here to downlaod the Directive

PIM – Innovative Solution for Ensuring Consistent and High-Quality Product Information

EMA (ex EMEA) is performing a pilot phase of what is known as a Product Information Management system (PIM).

It is about interactive IT interface for the submission, review and corresponding update of the product information documents (SmPC, PIL and Labelling) in all 3 community procedures: Centralized, DCP and MRP and for the national procedure as well.

The Difficulty in Readability Testing

Since readability testing became a necessity for better patient understanding of leaflets, there has been a plethora of ways to test a leaflet.   To the outsider, presenting a leaflet to a participant, asking a set of preset questions and recording the responses could appear to be enough to gauge the user friendliness of a Package Leaflet (PL).  However, a simple yes/no dichotomic approach quickly yields an unforeseen variable which can aptly be demonstrated in the following hypothetical situation.

Romania - Notice on Change of Access to Information on Centrally Authorised Medicinal Products

The NMA hereby informs you on replacement of PDF files in the “Useful Information” section of the main menu, containing the Romanian version of the Summary of Product Characteristics (SPC) of centrally authorised medicinal products, with a table in Excel format including the following data: name of centrally authorised medicinal products, medicinal product registration number in the Community Register of centrally authorised medicinal products and the marketing authorisation holder (MAH).


Business Advertising Activity

Hungarian  National Institute of Pharmacy has published  new guidelines in order to ensure the protection of consumer interests and sustain market competition which serves economic efficiency and social welfare, while recognizing the importance of professional self-regulation, the Parliament hereby passes the following Act to regulate business advertising activity for the purposes of achieving fair communication with consumers, protecting the interests of enterprises, observing the requirements of fair business practices, and facilitating the sale of goods and services.