GDP en Farmatec: wat betekenen deze certificeringen?
Voor farmaceutische organisaties die een distributie- of fulfilmentpartner zoeken.
Responsible Person (RP)
Aangewezen verantwoordelijke voor implementatie & naleving. Verbindt operatie en regelgeving.
AANSPREEKPUNT IGJTemperatuurbeheersing & monitoring
Gevalideerde ruimtes en transport. Continu gemonitord; afwijkingen vastgelegd.
GEVALIDEERD & GEMONITORDStrikte documentatie
Traceerbaar dossier van elke handeling: inkoop, ontvangst, opslag, uitgifte, retour.
VOLLEDIGE TRACEERBAARHEIDScheiding producten & status
Fysiek gescheiden: goedgekeurd, quarantaine, retour, verlopen — naar risicoprofiel.
FYSIEK GESCHEIDENVerificatie authenticiteit
Unieke beveiligingscodes controleren en actief screenen op vervalsing.
CONFORM FMDBeheer uitbestede activiteiten
Uitbesteding blijft jouw verantwoordelijkheid: contracten, audits en toezicht.
CONTRACT · AUDIT · TOEZICHTMag juridisch NIET als tussenschakel optreden.
Kwaliteitsrisico komt bij u te liggen.
MSA: Groothandel, Apotheekfunctie & Marketing onder één dak. | Certificering als fundament, niet als eindpunt. Compliance is verweven.
For pharmaceutical organizations seeking a distribution or fulfillment partner, two terms are unavoidable: GDP and the Farmatec wholesale license. This article explains what they entail, why they matter, and what it means that MSA meets both requirements.
Two different things that are inextricably linked
GDP and the Farmatec wholesale license are often mentioned in the same breath, but they are not the same thing.
The Farmatec wholesale license is a legal authorization. Farmatec is an implementing organization of the Ministry of Health, Welfare and Sport (VWS) and issues this license – following advice from the Health Care and Youth Inspectorate (IGJ) – to organizations wishing to purchase and distribute medicines within the European Economic Area. Without this license, a company is simply not allowed to conduct operations with medicines as a wholesaler. It is the gateway.
GDP (Good Distribution Practice) is the standard you must comply with once you pass through that gate. It is the European quality system that describes how medicines are correctly stored, transported, documented and delivered: from manufacturer to end user. GDP ensures that when a medicine arrives with the patient or healthcare provider, it has exactly the same quality as when it left the factory.
The license gives you the right to distribute. GDP determines how you do it.
What GDP means in practice
GDP is not a paper exercise. The guidelines are concrete and operational. For an organization wanting to be GDP-compliant, this means, among other things:
A Responsible Person (RP)
Every license holder is required to have a designated person responsible for the implementation and compliance with GDP within the organization. This official is the point of contact for the IGJ and the link between operations and regulations.
Temperature control and monitoring
Medicines are sensitive. Storage facilities and transport vehicles must be validated for the required temperature conditions, and continuous monitoring must be in place. Deviations are documented and assessed.
Strict documentation
Every action – purchase, receipt, storage, issue, return – has a traceable file. Traceability is not an additional requirement; it is the core of the system.
Separation of product categories and statuses
Products with different statuses – approved, quarantined, returned, expired – are stored physically separately. The same applies to different product types, depending on their risk profile.
Verification of authenticity
GDP-obligated organizations are required to verify unique security codes on prescription medicines and actively monitor for counterfeits. An obligation arising from the European Falsified Medicines Directive.
Management of outsourced activities
If parts of the distribution process are outsourced to third parties, the license holder remains responsible. Outsourcing requires contracts, audits and supervision.
The IGJ oversees compliance with all these requirements. For new license holders, an initial inspection takes place; thereafter, risk-based inspections follow. Inspection reports are public.
Why this is relevant for pharmaceutical partners
As a pharmaceutical organization – whether a manufacturer, marketing authorization holder or pharmacy – you are legally responsible for the quality of your product until it reaches the patient. That responsibility does not end at the factory gate or at the moment of transfer to a distribution partner. You are co-dependent on the quality assurance of each link in your distribution chain.
A partner without a Farmatec license is not legally permitted to act as an intermediary in the distribution of medicines. A partner with a license but without demonstrable GDP compliance places a risk on you: during an inspection, a recall or a quality incident, the entire chain will be examined.
Choosing a GDP-certified partner with a Farmatec wholesale license is therefore not a luxury, it is a basic requirement for every responsibly organized distribution chain.
What MSA offers in this regard
MSA holds the Farmatec wholesale license and operates fully in accordance with international GDP guidelines. In the world of direct mail and fulfillment, this is not a given – MSA is the only organization in this sector in the Netherlands that possesses this combination.
What this concretely enables for pharmaceutical partners:
Pharmaceutical fulfillment as an integrated service
MSA can not only logistically process medicines and medical products, but also legally correctly distribute them to pharmacies, healthcare providers and, increasingly, directly to patients.
Direct-to-patient distribution
The combination of fulfillment expertise and pharmaceutical licenses makes MSA suitable as a partner for e-commerce models where medication or medical products are delivered directly to end users, a growing segment in the pharmaceutical market.
Quality-assured packaging and assembly
MSA’s roots lie in high-quality manual packaging work. That precision – applicable to complex, personalized or fragile products – directly aligns with the requirements that pharmaceutical packaging and device assembly demand.
Traceable documentation.
MSA works with documented processes that comply with GDP traceability requirements, ensuring that every step in the chain is verifiable and controllable.
Point of contact for compliance
As a partner with its own RP’s and GDP structure, MSA is able to act as a full-fledged discussion partner in audits, inspections and quality meetings. Not as a logistics extension, but as a co-responsible link.
Certification as foundation, not endpoint
Having a Farmatec license and GDP compliance is not a static matter. The IGJ maintains oversight, European guidelines are periodically updated, and operational requirements evolve with the market. For MSA, compliance is not a department, it is woven into how the company operates, for thirty years.
For pharmaceutical partners looking for a distribution or fulfillment partner that understands the regulations, has the structures in place and takes responsibility seriously: that foundation is ready at MSA.
Want to know more about what MSA can mean for your pharmaceutical distribution or fulfillment? Please contact us via www.msabv.nl.
MSA-assistent