Pharma Brexit Services
Manufacturing and Distribution License Support, QP Support, QP Training, Interim QP Services
Current political developments force British pharma companies to prepare for an uncertain future. Transferring activities to the Netherlands is an efficient and effective strategy successfully implemented by many of these pharmaceutical companies. When the Brexit negotiations have been concluded, the Marketing Authorization Holder (MAH) must be based in the European Union. Many British organization are moving their MAH to the Netherlands.
PCS (est. 1990) is your local, Dutch partner for all Brexit preparations. We assist companies who have transferred Marketing Authorisations (MAs) of their products from the UK to the EU and need the appropriate licenses in the Netherlands. We liaise with Dutch regulatory authorities and guide you in the submission of license applications.
EU MAH Requirements
The MAH is required to have a Quality Management System (QMS), including Pharmacovigilance (PV). Additionally, a Qualified Person Responsible For Pharmacovigilance (QPPV) must be based in the European Union.
Our Brexit services apply to the following companies (amongst others):
- Pharmaceutical organisations wanting to obtain a Dutch Manufacturing, Distribution, Controllled Drugs and Veterinary Licenses as a result of the Brexit.
- Pharmaceutical organizations that need a certified QP within the EEA.
- Pharmaceutical organisations that perform batch release and QC testing in the UK and are required to move their site(s) to the EU.
- Pharmaceutical organisations that have moved Marketing Authorisation Holder (MAH) to the EU and need a Quality Management System
Why Choose PCS?
PCS has the experience and expertise to analyse your current situation accurately and help you navigate the regulatory hurdles. Allowing you to focus on your work without being hindered by translation issues, unnecessary bureaucratic delays or confusion over the Dutch regulatory system.
Many British organisations are struggling with the Dutch regulatory inspection and licensing system. In the UK there's only the MHRA, while in the Netherlands the regulatory responsibilities are spread out over several agencies, such as IGJ, CBG-MEB and Farmatec. The links between these organisations, their requirements and functions can be confusing. PCS has been active in the Netherlands since 1990. We know the regulatory institutions and their officers, we know the requirements and speak the language.
"PCS (est. 1990) is your local, Dutch partner for all Brexit preparations."
We assist companies who have transferred Marketing Authorisations (MAs) of their products from the UK to the EU and need the appropriate licenses in the Netherlands. We liaise with Dutch regulatory authorities and guide you in the submission of license applications.
Proven Track Record
- License request support, QA and QP support for two international organizations moving their MA from the United Kingdom to the Netherlands.
- Manufacturing license inspection preparation, QMS set-up and overall GMP upgrade for a producer of herbal medicine (the Netherlands). EU approved.
- Assistance in start-up and quality systems for Protein Sciences (Meriden U.S.). FDA approved.
- Assistance in EMA inspection preparation for Mallinckrodt (the Netherlands). EU approved.
- Assistance in license requests for a Dutch producer of medical devices (the Netherlands). Approval pending.
- Genibet (Lisbon, Portugal). Design Qualification of a Biotech Manufacturing facility and QA support to Licensing. EU approved.
Our consultants have performed a significant number of assignments globally, in a range of different industries.
We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.
Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.
Overview of Our Services
Click here to contact us if the service you require is not listed below.
- GAP Analysis and Benchmarking
- Risk Assessments of (Proposed) QA Systems
- Development of Pharmaceutical Quality Systems & Quality Culture
- Definition of Suitable Metrics for Quality Monitoring and Improvement
- Practical Implementation Support of Entire Quality Systems or parts thereof
- Coaching and training of personnel at all levels within the organization in the principles and practice of Quality Systems
- Independent inspections to determine ongoing compliance to in-house, corporate or official Quality System requirements
- United States Food and Drug Administration (FDA)
- European Medicines Agency (EMA)
- World Health Organization (WHO) Qualification
- World Health Organization (WHO) Pre-Qualification
- Russian Good Manufacturing Practices (SID & GP)
- Indian National Regulatory Authority (NRA)
- Other National Regulatory Authorities