Track & Trace: Amendment of the Delegated Regulation on Safety Features
On 17 March 2021, the Delegated Regulation (EU) 2021/457 was published in the Official Journal of the European Union. It amends the Delegated Regulation 2016/161 regarding an exemption from the obligation for wholesalers to decommission the unique identifier (UI) of medicinal products exported to the UK.
The Higher Regional Court (OLG) of Hamburg has decided, in the context of proceedings aimed at the issuance of an interim injunction against a wholesaler, that medical cannabis (cannabis flowers) is not (yet) a medicinal product at the wholesale level.
Judgement of Federal Administrative Court of Germany on the Required Expertise of the Responsible Person for GDP
The Federal Administrative Court of Germany (Bundesverwaltungsgericht - BVerwG) has dealt with the question of what requirements are to be placed on the expertise of the Responsible Person for GDP. In a recently published judgment, the court has clarified that knowledge of pharmacy comparable to that taught in a pharmaceutical (vocational) training is not required. Rather, the knowledge can also be gained through practical experience.
Questions & Answers on Good Distribution Practices (GDP) - Part 2
In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 2 deals with questions related to the role of the Responsible Person for GDP.
Insufficient Quality System leads to GDP Non-Compliance Report
Wholesalers must ensure that their Quality Management Systems (QMS) is aligned with the GDP requirements. Otherwise, this can lead to a GDP Non-Compliance Report, as a recent example entered into the EudraGMDP database by the Romanian authority shows.
Not Approved Storage Facilities lead to GDP Non-Compliance Report for Czech Wholesale Distributor
The competent authority of Czechia has entered a new GPD Non-Compliance Report into the EudraGMDP database due to the fact that a Czech wholesale distributor does not provide approved storage facilities.
Questions & Answers on Good Distribution Practices (GDP) - Part 1
In October 2020, the ECA Academy offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Part 1 deals with questions related to GDP training.
Track & Trace: Do Medicinal Products have to be Decommissioned when Distributed to the UK?
Due to the Brexit, the question arises whether medicinal products have to be decommissioned in advance when distributed to the UK. Now, the European Commission has decided on a transition period for decommission with regard to exports to the UK.
Distribution of Temperature-Sensitive Pharmaceuticals: Requirements according to the EU GDP-Guidelines
With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from the production sites to the storage and distribution centres and then on to the local vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also any other temperature-sensitive product in general. The EU GDP-Guidelines contain some specific requirements for temperature-sensitive products in this regard.
New MHRA Inspectorate Blog GDP Post: Be aware of Fake Websites when Qualifying New Customers and Suppliers Using Online Resources
Qualification and re-qualification of suppliers and customers are a fundamental part of Good Distribution Practice (GDP). Using online resources and publicly available databases is established as a standard requirement during this process. But relying (only) on information that is easily available to everyone may involve a high risk. In this context, a new post, entitled “Qualifications of suppliers and customers online: reliable or fake news?” has been published in the MHRA Inspectorate blog.