Dr Ina Bach, Dr. Bach
Dr Johannes Fröhlich, Akroswiss
Dr Felix Kesselring, Bratschi
Dr Remo Studer, Galexis
- 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 (final implementation on January 1st 2016). This was realised through an adaptation of Annex 2 of Ordinance on Establ ishmentLicences(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.
Various transitional provisions for licenses issued under the old legislation are defined. However, for all new/renewed applications, the new legislation will apply in its entirety.
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.
Legal Bases for the Distribution of Medicinal Products
- Legal basis in Switzerland including EU regulations
- The Ordinance on Establishment Licences OEL (AMBV, OAMéd)
- The revised Therapeutic Products Act (HMG 2): relevant changes
- GMP/GDP Interface
- Working with contractors
Practical Implementation in Switzerland
- The GDP Inspection: what do inspectorates expect and how to prepare
- Wholesaler vs. Pre-Wholesaler: interfaces and delimitation
- Transport at storage conditions: best practices
- Case Study: transport validation
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
- Cross-border Distribution: Requirements for Import and Export
- Requirements for specific products
- Qualification of suppliers and recipients
- Senior Management
- Responsible Person
- Principles of liability
- Who is liable?
- Potential sanctions
- Examples from the real life, case law
Storage and Transport: Practical Aspects (Interactive Session)
- Transport qualification/ validation
- Transport at ambient conditions: expectations and control
- Deviation management
- Cool and cold chain
- Risk Analysis