# Life sciences: board structure and who binds the company
A Dutch life sciences board binds the company on ordinary contracts, but it does not automatically carry the marketing authorisation, the manufacturing licence, or clinical trial sponsor status. Those sit with the legal entity as licence holder and move only through the regulator's own procedure, never by a share sale or a change of directors alone. This gap is what catches buyers and boards who assume that control of the company settles the question of who may act.
Why this arises here
This mismatch is specific to sectors where the state, not the company, decides who holds a licence. In life sciences, the College ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board, CBG-MEB) issues and records marketing authorisations. The Health and Youth Care Inspectorate (IGJ) issues manufacturing and wholesale distribution licences. Where a clinical trial is running, the reviewing medical ethics committee records who is registered as its sponsor. None of these registers takes the board's power of representation as its reference point. Each takes the identity of the licence holder or registered sponsor, and that identity changes only when the holder files for the change, on its own timetable.
The mechanics in short
Under Dutch law, the board (bestuur, management board) is the organ that represents the company externally. A statutory director (statutair bestuurder, statutory director) is registered in the Trade Register held by the Chamber of Commerce, and the register states whether that director may act alone or only jointly with another director or officer. A counterparty checking that register extract can generally rely on what it shows, even if the underlying internal resolution was defective, provided it acted in good faith. This is the ordinary corporate law and governance question that arises whenever a director signs, and on its own it is the same question in life sciences as in any other sector.
The pattern specific to life sciences
What is specific here is that several of the company's most valuable assets are not contracts the board can freely assign. A marketing authorisation is granted to a named legal entity, and CBG-MEB requires a formal variation or transfer filing before another entity can hold it, including after a share deal has closed. A manufacturing or wholesale distribution licence under IGJ works the same way: the licence follows the entity IGJ has vetted, not the entity's new shareholder. A clinical trial has a sponsor, recorded with the reviewing committee, and that identity is checked against the trial file rather than against the Trade Register.
In each case the board's ordinary authority to sign is real, but it does not, on its own, move the asset the deal is usually about. A share purchase agreement that closes without a parallel filing to the relevant regulator can leave a buyer holding a company whose principal licence is, on the regulator's own record, still held by the previous constellation, unresolved and open to challenge.
What to check
Before relying on board minutes or a signed contract in a life sciences matter, check four things. First, whether the marketing authorisation, manufacturing licence, or wholesale licence is held by the entity itself or by an affiliate. Second, whether a change-of-control notification to CBG-MEB or IGJ is a closing condition or a post-closing obligation, and who carries the risk in between. Third, who is currently recorded as sponsor on any live clinical trial, since that registration does not follow the corporate transaction automatically. Fourth, whether the Trade Register extract for the entity matches the person actually corresponding with the regulator, because the two are not always the same individual.
Who decides what
| Asset or role | Who decides it | Register or authority | What moves it |
|---|---|---|---|
| Marketing authorisation | CBG-MEB | CBG-MEB authorisation register | Variation or transfer filing, not a share deal |
| Manufacturing licence | IGJ | IGJ licence register | New or amended licence application |
| Wholesale distribution licence | IGJ | IGJ licence register | Notification and vetting of the new holder |
| Clinical trial sponsor status | Reviewing medical ethics committee | Trial file, not the Trade Register | Sponsor change filed with that committee |
| Ordinary contracts | The board | Trade Register (KVK) | Signature by an authorised director |
What this does not cover
- This page does not cover the substantive requirements for obtaining a marketing authorisation, a manufacturing licence, or trial approval.
- It does not cover the pharmacovigilance, GMP, or reporting obligations that continue after a transfer of a licence.
- It does not cover employment or engagement terms for a qualified person or a responsible person under sector-specific rules.
- It does not cover litigating a disputed transfer or a disputed sponsor change before a Dutch court.
- It does not cover any jurisdiction other than the Netherlands.
Questions
Does a share purchase automatically transfer a marketing authorisation held by the target?
No. A change of control at board or shareholder level does not by itself move the authorisation. CBG-MEB requires its own variation or transfer filing, and the authorisation remains registered to the previous holder until that filing is processed.
Who can bind a life sciences company on a clinical trial agreement?
The same director or officer who can bind the company on any contract, under the authority recorded in the Trade Register. Whether that person is also the entity recognised as sponsor of the trial is a separate question, checked against the trial's own registration rather than against signing authority.
Where do we check who currently holds a manufacturing or wholesale licence?
With the Health and Youth Care Inspectorate (IGJ), which issues and records these licences directly. The Trade Register shows who may sign for the company; it does not show who holds the licence, and the two records answer different questions.
Author
Sanne de Wit, structures, holding and tax. This author works on how Dutch entities are held together, and on where corporate authority and licence-holder status diverge across sectors.
Where this leads
This is a corporate governance question with a sector-specific twist, and it sits inside the wider corporate practice rather than as a stand-alone problem. Where a deal will require a filing to CBG-MEB, IGJ, or a sponsor change, a structure report ordered before a licence application maps who holds what, and where the gaps sit, before a signature is relied on. A structure report lists, entity by entity, who is registered to sign and who is registered as the licence holder, so the two are compared side by side rather than assumed to match.
The same board-authority question recurs, on different licences, in the equivalent question for logistics and transport. Where the concern shifts from licence transfer to personal exposure, see boardroom defences in energy and renewables and personal liability for environmental breaches.
Last legal review: 2026-09-28