Quality Risk Management ICH Q9 – Revision published for public comments
BREXIT – How Can We Help?
As the Brexit go-live date of 30 March 2019 approaches there are many articles being published across a variety of media platforms outlining that Brexit contingency plans should be put in place.
For marketing authorisation holders (MAH) there are specific activities that are required to be conducted within the EU / EEA. As it currently stands, the United Kingdom will become a ‘third country’ post Brexit. Therefore, if these activities are currently being conducted in the UK then they will need to transfer to an EU/EEA country as part of the contingency planning process.
The EMA urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU. The following guidance document was recently published by the EMA on 19 Jun 2018 in relation to “Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure, EMA, 19 June 2018” to prepare for the UK’s exit from the EU by the 30 March 2019.
What exactly can PharmaLex do to help you plan for Brexit?
PharmaLex have a team of consultants who are currently supporting several companies with their Brexit contingency planning. We have considerable expertise in the different requirements and the respective timelines that are required to be met before the 30 March 2019 deadline. Contingency planning is unique to each company and PharmaLex can offer the following range of services which can be tailored via consultation to meet your specific needs.
- Conduct Risk Assessment and gap analysis of your existing Brexit contingency planning activities and support any remediation activities required.
- Provide guidance on the MAH considerations associated with Brexit and address situations where the UK is the current MAH, batch release site, batch control sites, location of QPPV& PSMF, transfer of orphan designation, etc.
- Host workshops to support you in the identification of the licencing (WDA / MIA) requirements based on the physical and financial product flows of your company’s existing or proposed supply chain model. In addition, PharmaLex can provide expert advice on the recommended supply chain flow to best meet your company’s requirements.
- Act as a MAH in the EU for your company.
- Where GxP activities are being conducted by various parties PharmaLex can develop and implement the Quality Management Systems needed to support these activities and guide you through the regulatory application and inspection process.
- Provide advice on the most appropriate MAH compliance structure (QMS) and draft SOPs, Third Party Quality Agreements and Intercompany Agreements.
- Support the qualification of shipping containers and supply chain routes.
- Provide GMP and GDP training to different parties in your supply chain.
- Conduct mock inspections in advance of regulatory inspections within your company or organisation.
- Conduct audits of the various parties in your company’s supply chain.
- Provide adhoc consultancy support whereby a team of consultants are on standby to evaluate your query and generate a formal response for your records.
- Provide regulatory assistance with preparation of variations to support Brexit driven changes.
We, at PharmaLex, are ready to help you prepare. If you would like further information or wish to discuss how we can tailor our services to meet your specific need’s please connect with us to discuss +353 1 846 4742 or contactirl@pharmalex.com
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