# Life sciences: decisions taken at group level
In a life sciences group, a resolution taken at holding level does not automatically carry across to the entity holding the manufacturing authorisation or the marketing authorisation: those are granted to a named legal person, not to the group. Any restructuring, licensing or change-of-control decision has to be checked separately against the entity that actually holds the regulatory status. This page is for groups that hold pharmaceutical, medical device or biotech assets across more than one Dutch entity.
Why this arises in life sciences
This split exists because Dutch and EU life sciences regulation is entity-based, not group-based. A manufacturing authorisation, a marketing authorisation and a GMP certificate are each issued to one named legal person. A corporate resolution taken at the level of a Dutch holding company changes control or ownership of a subsidiary; it does not by itself change who holds the authorisation attached to that subsidiary. In most other sectors, the group decision and the licence that supports the business sit in the same entity, so the split rarely matters in practice. In life sciences the two tracks run in parallel, each with its own procedure, its own timing and its own regulator.
The mechanics in short
A group decision inside a life sciences structure normally passes through three layers. The board of the Dutch holding company resolves on the transaction under the mandate set by the articles of association. Where the structure has a supervisory board, that board approves before the resolution is executed, and the exposure this creates for supervisory directors is a distinct question, covered separately under supervisory board liability. Where the decision is significant enough to affect the workforce, works council consultation runs alongside the corporate approval and follows its own timeline.
This sequence is standard corporate law and governance practice in the Netherlands and is not specific to the sector. What is specific is what comes next: because the patent portfolio, the manufacturing site and the distribution entity are typically three separate Dutch companies, the parent's approval authorises the group to proceed but does not itself move the regulatory status held by the operating entity. That step follows separately, and until it is complete, the entity named on the authorisation remains the one responsible under Dutch law and under EU law for the product on the market.
The pattern specific to life sciences
Three patterns recur in life sciences groups and do not appear in the same form elsewhere. First, the intellectual property that carries most of the value, patents and know-how, is usually held in one entity and licensed to the operating companies; a group decision to change that licence, extend it or bring it in-house changes the economics of every subsidiary at once. Second, the marketing authorisation for a medicinal product is registered to a named holder, and a group restructuring that moves a product line to another entity requires a separate change-of-holder process with the medicines regulator before the new entity may lawfully place the product on the market. Third, the manufacturing authorisation and the GMP certificate attach to a specific production site, not to the company that owns the site; selling the site or moving production into a different Dutch entity means applying for a new authorisation, not transferring the old one.
The situation that only arises in this sector is the change-of-holder process itself: no other sector has a comparable step where a corporate decision to move an asset between two entities is conditional on a separate regulatory sign-off before the receiving entity may sell the product.
What to check
Before you sign off a group decision in this sector, check the following.
- Which Dutch entity is named as the holder of the marketing authorisation for each product affected by the decision.
- Which entity holds the manufacturing authorisation and the GMP certificate for the production site in question.
- Whether the licence agreement between the IP holding entity and the operating entity contains a change-of-control clause triggered by the decision.
- Whether works council consultation applies, given the size of the workforce affected.
- Whether the decision needs supervisory board approval under the group's own articles of association.
The same discipline of checking the entity behind a document applies further upstream, before a licence or supply relationship is even signed. See what is checked before a supply agreement is put in place.
Decision and the regulatory step it triggers
| Corporate decision | Corporate step | Regulatory step | Body involved |
|---|---|---|---|
| Move IP to a new group entity | Board resolution, licence amendment | Notify or re-register if the marketing authorisation is affected | Medicines regulator, healthcare inspectorate |
| Sell a manufacturing site | Board resolution, works council consultation where applicable | New manufacturing authorisation application by the new operator | Healthcare inspectorate |
| Change the marketing authorisation holder | Shareholder or board resolution on the underlying transaction | Change-of-holder procedure with the regulator | Medicines regulator, or EMA depending on the route |
| Appoint a new statutory director | Board and general meeting resolution | Generally none, unless the director is named on an authorisation | None as a rule |
What this does not cover
- This page does not cover the clinical trial approval process itself, which runs before a separate ethics and research committee, not before the corporate bodies described here.
- It does not cover pricing and reimbursement decisions, which sit with the healthcare insurance regulator, not with the group's board.
- It does not cover the employment law consequences of a group decision beyond the fact that works council consultation may apply.
- It does not cover litigation over a group decision before a Dutch court; that runs on a separate track with its own procedure.
- No public figure exists for the fee charged on a change-of-holder application. Check the current tariff directly with the regulator before you rely on a number.
Questions
Does a parent board resolution automatically transfer a marketing authorisation to a new group entity?
No. A marketing authorisation is issued to a named legal entity. Moving it to another Dutch entity requires a separate change-of-holder application, regardless of which corporate body approved the underlying transaction.
Who holds the manufacturing authorisation in a life sciences group that operates from a single Dutch site?
The authorisation attaches to the legal entity operating the site, not to the group as a whole. Selling the site or restructuring the entity means the new operator applies for its own authorisation rather than inheriting the old one.
Does works council consultation apply to a group decision that only affects an IP holding entity?
It depends on whether the decision affects the workforce of an entity with its own works council. A decision confined to an IP holding entity with no employees typically falls outside that consultation duty, but the position should be checked against the group's own structure.
Eva Kuipers writes on governance and the Enterprise Chamber at Nolthenius & Partners. Her work covers board mandates, supervisory approval and the points where a corporate decision meets a separate regulatory track, the pattern this page describes for life sciences groups.
The logistics and transport sector has a comparable split between the corporate decision and the licence attached to an operating entity: see the equivalent question for logistics and transport groups. Where the decision forms part of a formal restructuring rather than a single resolution, the mechanics differ again: compare the restructuring plan for a real estate group.
This page sits under the firm's corporate practice. Where the question is which entity in the structure actually holds a given authorisation or licence, that is precisely what a structure report is built to establish and costs a fixed fee per tier.
Last legal review: 2026-09-28