Course No 15284
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Dr Ina Bach
Dr. Bach AG, form. RHI
Ursula Eggenberger Stöckli
Bratschi Wiederkehr & Buob AG Lawyers
Dr Johannes Fröhlich
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
Quality requirements for medicines do not end after production and packaging. Medicines and APIs are often shipped over long distances and different climate zones and stored in various warehouses. Once the WHO has taken the lead with its guidelines „Good Storage Practices for Pharmaceuticals“ (2003) and „Good Distribution Practices for Pharmaceutical Products“ (2010), more and more compliance with good storage, transportation and distribution practice was emphasised worldwide. Another milestone were the EU-GDP guidelines from 2013 with a lot of intensified demands.
For quite a while it was rather unclear how these guidelines are applicable in the non-EU country Switzerland. Under the Agreement of 21 June 1999 between the Swiss Confederation and the European Community (Mutual Recognition Agreement, MRA), Switzerland obliged to comply with the EU-GMP regulation.
However, GDP was not covered.
Since 1 July 2015, the EU GDP guidelines do also apply for Switzerland. This was realised through an adaptation of Annex 2 of Ordinance on Establishment Licences (Arzneimittel-Bewilligungsverordnung - AMBV or
Ordonnance sur les autorisations dans le domaine des médicaments - OAMéd)
This seminar is aimed at all 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.
EU Regulations and their Implementation in Switzerland
Legal basis in Switzerland including EU regulations
The Ordinance on Establishment Licences OEL (AMBV, OAMéd)
Working with contractors
Implementation in Switzerland
Status quo and possible new Technical Interpretations
Expectations of the inspectorates
Expectations for small and medium-sized companies
Transport at storage conditions
Differences between wholesaler and retail business
Tasks and Responsibilities
Requirements and due diligence for the Responsible Person according Art. 9 and 13 of the Ordinance on Establishment Licences
Storage and distribution: current expectations
Qualification of suppliers and recipients
Cross-border Distribution: Requirements for Import and Export
Relevant requirements for import and export
EU, EEC and MRA
Storage and Transport: practical Aspects
Transport qualification/ validation
Transport at ambient conditions: expectations and control
Cool and cold chain
Principles of liability
Who is liable?
Examples from the real life, case law