GDP in Switzerland (GDP 3)

12 September 2024, Basel, Switzerland

Course No. 21328



Dr Ina Bach

Dr Ina Bach

Dr. Bach

Dr Johannes Fröhlich

Dr Johannes Fröhlich


Dr Remo Studer

Dr Remo Studer


Felix Kesselring

Felix Kesselring

Bratschi Rechtsanwälte


  • Learn and discuss how to manage your distribution activities GDP-compliant.
  • Exchange opinions and convey possible solutions to problems addressed in case studies.
  • Benefit from the speakers’ experience in industry, authority and legal advice.
Since 1 July 2015, the EU GDP guidelines do also apply for Switzerland (final implementation on January 1st 2016). This was realised through an adaptation of Annex 2 of Ordinance on EstablishmentLicences(Arzneimittel-Bewilligungsverordnung - AMBV or Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd).

On 1 January 2019, the revised Therapeutic Products Act (HMG 2) and the majority of the revised implementing ordinances
(Therapeutic Products Ordinance Package IV) came into force - with some interesting changes.
Holders of an operating license for wholesale activities are obliged to designate a Responsible Person (“Fachtechnisch Verantwortliche Person, FvP)”.
The requirements for a Responsible Person are described in the Ordinance on Establishment Licences.

Target Group

This course has been designed for employees, specialists and managers from storage, transportation and distribution as well as their colleagues from quality control, quality assurance and production, which are involved in the various processes of drug logistics.

Important Information

The presentations of this GDP Course will be available for download and your print-out one week before the conference. Note: there will be no print-outs available during the course.


GDP in Switzerland (GDP 3)

Seminar Programme as PDF

Legal Bases for the Distribution of Medicinal Products
  • Swiss Law and European Law
    - Act on Therapeutic Products
    - Ordinance on Establishment Licences
    - European Guidelines on Good Distribution Practice of Medicinal Products for Human Use (GDP)
    - European GDP Guidelines for Active Substances
  • Outsourced activities
  • Written contract for outsourced activities
Tasks and Responsibilities
  • General considerations on GDP in Switzerland
  • Legal Basis
  • Revision of the Therapeutic Products Act (HMG) and ist effects
  • Authorization types
  • GDP Requirements
  • Quality in the supply chain
  • Technically Responsible Person (FvP) - General
  • FvP - Delegation
  • Responsibility and liability: Terms
  • Different kinds of responsibilities
    - Administrative responsibility
    - Civil responsibility
    - Criminal responsibility
  • Protection of the Responsible Person
  • The Responsible Person in case law
Practical Implementation in Switzerland
  • The GDP inspection: preparation and implementation
  • Wholesale vs. pre-wholesale: demarcation and similarities
  • Transport in accordance with storage conditions: best practices
  • Case study: validation of transport routes, qualification of transport vehicles
Storage and Transport: Practical Aspects (Interactive Session)
a) Warehouse
- Requirements
- Qualification
- Mapping
- Hygiene
- Documentation
b) Transport
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis
- Training

Regular Fee*: € 1290,-
EU/GMP Inspectorates*: € 645,-
GDP Association Member Discount*: € 1090,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
Further dates on-site
Not available
Further dates online
Further dates online
Not available
Not available

Do you have any questions?

Please contact us:
Tel.: +49 6221 8444-0

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Testimonials about our courses and conferences

“Fantastic course – I really enjoyed the interactive structure & greatly appreciate social activity.”

Anthony Cummins, Sebela Pharmaceuticals, Ireland
GMP Auditor Practice, September 2023


“Very well organized, information on point without being overwhelming.”

Eleni Kallinikou, Pharmathen
Live Online Trainng - Pharmaceutical Contracts - Febuary 2024


“Good overview of different types of agreements, good to see both the GMP and the legal angle”

Ann Michiels, Johnson&Johnson
Live Online Trainng - Pharmaceutical Contracts, Febuary 2024



“Well prepared presentations and good presenters. I also like the way of asking questions.”

Alexandra Weidler, Hookipa Biotech GmbH, Austria
Live Online Training – QP Education Course Module A, November 2023