Brexit Pharma MAH Transfer to the Netherlands - Qualified Person and Consultancy Services

YOUR LOCAL BREXIT PARTNER

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.

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.

For Whom?

Our Brexit services apply to the following companies (amongst others):

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

Our Advantages

Global Experience

Our consultants have performed a significant number of assignments globally, in a range of different industries.

Broad Knowledge

We are a dedicated team of consultants who know all ins and outs of Quality Systems and its potential issues.

Seasoned Consultants

Our consultants work in a great number of companies across the pharmaceutical industry as Subject Matter Experts.

Overview of Our Services

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