nl en

Legislation of Production of Medicinal Products


Admission requirements

Students of the master Bio-Pharmaceutical Sciences specialisation Industrial Pharmacy (mandatory course) and other students of the master Bio-Pharmaceutical Sciences.


In the European Union a comprehensive legal framework for the authorization, manufacture, and distribution of human medicines is in place which should safeguard public health, while not to hinder the development of the pharmaceutical industry or trade in medicinal products within the European Union. In this course the students are familiarized with the European Directive 2001/83/EC governing medicinal products for human use in the European Union and national laws, specifically the Dutch Medicines Act. The relationship between these two sources will be discussed. Subsequently, it will be examined how the rules work out in daily practice, from the perspective of the manufacturer, importer or wholesaler, but also from the Health Care Inspectorate, and the Medicines Evaluation Board.

This course aims to:

  • Familiarize students with the European Directive 2001/83 /EC and the Dutch Medicines Act.

  • Provide an overview of standards and rules that apply in the pharmaceutical industry and that arise from national and European regulations.

  • Provide insight into how the rules work out in practice.

Note that these are expert lectures series and that hence the content might change every year.

Course objectives

At the end of this course the student is able to:

  • Describe the relevant national and European legal frameworks for the authorization, manufacture, and distribution of human medicines.

  • Understand why (people in the) pharmaceutical need to comply with European and national laws and how to identify the specific legal requirements to comply with.

  • Explain how the legal frameworks ensure that medicines meet the criteria for efficacy, safety and quality in practice for application in humans.


One day course in semester 1, period 2.

You will find the timetables for all courses and degree programmes of Leiden University in the tool MyTimetable (login). Any teaching activities that you have sucessfully registered for in MyStudyMap will automatically be displayed in MyTimeTable. Any timetables that you add manually, will be saved and automatically displayed the next time you sign in.

MyTimetable allows you to integrate your timetable with your calendar apps such as Outlook, Google Calendar, Apple Calendar and other calendar apps on your smartphone. Any timetable changes will be automatically synced with your calendar. If you wish, you can also receive an email notification of the change. You can turn notifications on in ‘Settings’ (after login).

For more information, watch the video or go the the 'help-page' in MyTimetable. Please note: Joint Degree students Leiden/Delft have to merge their two different timetables into one. This video explains how to do this.

A detailed schedule of the course will be published on the Brightspace course module.

Mode of instruction

Lecture, tutorials (case study and discussion), self-tuition

Assessment method

This course requires active participation during the lecture and tutorials in which cases will be discussed. The course is concluded with an individual assignment based on which the final result (pass/no pass) will be determined.

The time and manner of the inspection and of the feedback session on the examination are specified in the Brightspace module of the course.

Reading list

Will be announced during the course.


Every student has to register for courses with the enrollment tool MyStudyMap. There are two registration periods per year: registration for the fall semester opens in July and registration for the spring semester opens in December. Please see this page for more information.

Please note that it is compulsory to both preregister and confirm your participation for every exam and retake. Not being registered for a course means that you are not allowed to participate in the final exam of the course. If you want to retake of the exam of the course without following the lectures, you have to contact the coordinator of the course to see if this is possible (you would have to passed the other assignments of the course in the earlier year).
Confirming your exam participation is possible until ten days before the exam.

Extensive FAQ's on MyStudymap can be found here.


Coordinator of the Industrial Pharmacy specialisation: Drs. Judith Mathijssen (


Maximum 20 students. Students of the specialisation Industrial Pharmacy of the master programme Bio-Pharmaceutical Sciences have guaranteed places.

This information is without prejudice. Alterations can be made for next year.