News and Educations

50 years of European Pharmaceutical Legislation


This year marks the 50th anniversary of the introduction of the first EU legislation on human medicines and the adoption of Council Directive 65/65. This Directive that was adopted on 26th January 1965 introduced clear rules and some founding principles that are valid until today and that are considered to be the beginning of the EU pharmaceutical legislation. A large number of legislative acts has been developed over 50 years, thus ensuring high standards of quality, safety of medicines and one of the most advanced systems for monitoring the safety of medicines. All medicines before being placed on the market of EU Member States must undergo strict criteria of quality, efficacy and safety to ensure maximal therapeutic efficacy and life quality of the patient.

In addition, the European pharmaceutical legislation promotes research and development of new medicines, thus contributing to the public health and well-being of the patient. Here you may find detailed information.

The European Medicines Agency (EMA) was established in January 1995 and this year marks its 20th anniversary. More information is accessible here.

On this occasion, the Croatian Pharmaceutical Society reminded on its webpages the public on the results of the Agency for Medicinal Products and Medical Devices (HALMED) within the programme of the Benchmarking of European Medicines Agencies (BEMA) within the EEA that were ranked as the best practice at the EU level.