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WDA & MIA Licensing Support in Pharma

PCS supports companies in obtaining WDA's or MIA's in the European Union. We have a proven track record and extensive knowledge on the Dutch (and other) markets in the European Union for establishing a pharmaceutical company.

Used by

Abbott
Roche
Pfizer

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Why choose PCS for license application support?

  • Extensive GMP and GDP expertise
  • We know what the government inspects and expects
  • Within the Netherlands we have a 100% success rate
  • Our team of ex-EU inspectors and experts guide you from A-to-Z

Get your wholesale or manufacturing license with PCS

With 30+ years of experience, PCS has the expertise and experience to guide you to achieving a WDA or MIA license. We will help you identify the path forward and set up a plan for implementation and obtaining the license.

Post-Brexit, we have helped a large number of UK companies obtain WDA's in the Netherlands in a short amount of time. Helping them set-up an organization, a Quality Management System, providing the training, contract QA staff, and ultimately liaising with authorities on the license process.

We help you obtain a Wholesale Distribution Authorization or Manufacturing and Import Authorization, first-time-right.

Manufacturing and Import Authorization (MIA)

Manufacturers and importers of medicinal products in the EU must have a MIA. This is the name of the license that allows you to perform the activity of importing medicine from outside the EU and manufacturing medicinal products inside the EU.

A MIA requires that you have implemented the EU GMP.

Good Manufacturing Practice (GMP) is a quality standard for the manufacture of pharmaceuticals. GMP ensures that pharmaceutical manufacturers must always follow the same quality requirements. Manufacturers are inspected against the GMP by governments.

If you pass the inspection, you will receive a license, and thereafter a GMP Certificate.

Wholesale and Distribution Authorization (WDA)

If you store medicinal products for more than 72 hours, you need a WDA. This license allows you to store and procure medicinal products inside the EU. If you request it, you may also export medicinal products outside the EU under the WDA.

A WDA requires that you have implemented the EU GDP.

Good Distribution Practice (GDP) is a quality standard for trading in medicinal products. GDP ensures that logistics providers store and trade medicine under strict quality requirements, to prevent mix-ups, for example. Wholesalers are inspected against the GDP by governments.

If you pass the inspection, you will receive a WDA, and thereafter, a GDP Certificate.

Jaap Koster, CEO of PCS, avatar

When you're inspected, inspectors want to see a state of control. It's not just about having the right documents, with the right contents. Inspectors want you to be the owner of your process and your product.

Eng. J.J.M. Koster
CEO of PCS

Avoid delays

To avoid delays in the application or change process of a Wholesale or Manufacturing license, it is important to submit applications as correctly and accurately as possible. PCS is happy to help you with this. With the help of years of expertise, we can unburden you by collecting the required documentation, compiling it and submitting it with a correctly completed application form.

How can PCS help me obtain a MIA or WDA?

Applying for or changing a MIA or WDA license can be complex. In particular, companies that are new to the pharmaceutical industry or want to set up a branch in the Netherlands from abroad can experience the Dutch licensing system as challenging.

PCS has the experience and expertise to guide pharmaceutical licensing processes to good results. If desired, PCS can take care of the entire GDP or GMP implementation process and submit the license application to the government and conduct the subsequent correspondence.

Services

  • Supply chain mapping,

  • Helping you find a Third-Party Logistics provider (3PL) or Contract Manufacturing Organization (CMO),

  • Quality Agreements with suppliers,

  • Supplier audits,

  • Creation, customization and implementation of your Quality Management System - using a proofed set of procedures - which have passed numerous inspections,

  • Temperature mapping,

  • Facility or warehouse qualification & equipment qualification,

  • Cleaning and process validation,

  • Computerized Systems Validation (where needed),

  • GMP or GDP training,

  • Mock-audit(s),

  • Inspection readiness services,

  • Preparing the license application or variation,

  • Submitting the license application or variation,

  • Presence before, during and after the regulatory inspection,

  • Inspection response,

  • After-care, where needed.

Optional services

In addition to the standard package PCS can help companies with "Quality as a Service", our consultants act as QA Managers and QA Officers, executing the tasks in the quality system and updating it continuously. This allows you to focus on running your business, while PCS becomes your Quality Assurance department.

Looking for an interim Responsible Person or interim Qualified Person? PCS has an extensive database of RP's and QP's in the Netherlands and Europe.

Finding permanent employees to staff your Dutch or European subsidiary can be challenging. In most cases, permanent fulltime employment is overkill and costly; but the government requires you to have employees. PCS has a number of consultants that can, for a number of hours per week, enter into flexible employment contracts with your organization. This saves you recruitment costs, is significantly more cost-effective and ensures that you meet the government's requirements.

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Frequently asked questions

Is a GMP certificate the same as a Manufacturing and Import Authorization (MIA)?

A Good Manufacturing Practice (GMP) certificate and a Manufacturing and Import Authorization (MIA) are not the same, although they are related in the context of pharmaceutical and medical product manufacturing and distribution. While a GMP certificate is evidence of adherence to quality manufacturing practices, a MIA is a legal authorization to manufacture and import products.

Is a GDP certificate the same as a Wholesale license?

A Good Distribution Practice (GDP) certificate and a Wholesale Distribution Authorization (WDA) are related but distinct concepts in the pharmaceutical industry. Both pertain to the distribution aspect of pharmaceutical products, but they serve different purposes. While a GDP certificate is a certification of compliance with quality standards in the distribution of pharmaceuticals, a WDA is a legal permission to engage in the wholesale distribution of these products.

What are the GMP regulations?

Good Manufacturing Practice (GMP) is a quality standard for the manufacture of pharmaceuticals. GMP ensures that pharmaceutical manufacturers must always follow the same quality requirements. Manufacturers are tested against GMP by governments.

What are the GDP requirements?

Medicines in the EU come from all over the world. Transport involves risks. To limit these risks, the European Commission has drawn up the Good Distribution Practice (GDP) guidelines. The GDP ensures that distributors of medicines do this safely. Distributors subject to the GDP guidelines are assessed by the government against the GDP guidelines and requirements.

Who needs a Manufacturing and Import Authorization (MIA)?

Manufacturers of medicines and active substances must have a GMP license and GMP certificate. Importers of medicines to the European Union must also have a GMP license and GMP certificate. Outside the EU, national governments regulate the GMP certification of manufacturers. For example, countries such as Japan, Canada and China have their own GMP. In the United States, the United States Food and Drug Administration (U.S. FDA) issues permits and certificates. On a global level, medicines are purchased by the World Health Organization (WHO). The WHO has set up its own GMP regulations and certification. In order to be allowed to supply medicines to e.g. Unicef, companies must go through WHO prequalification (WHO PQ) and comply with the WHO GMP.

Who needs a Wholesale Distribution Authorization (WDA)?

Logistics companies must comply with GDP requirements. These apply to the entire distribution chain of medicines and active pharmaceutical raw materials within the European Union. If you only transport medicines, without storage, you can voluntarily apply the GDP requirements to your transport activities. Distributors and wholesalers who store and distribute medicines for longer than 72 hours are required to obtain a wholesale license and GDP certificate. Outside the EU, the GDP requirements are less specific. National governments do, however, enforce principles comparable to the principles of the EU GDP. Think of quarantine requirements, pest control and temperature controlled transport.

How long is a GMP or GDP certificate valid?

As a rule, a GMP or GDP certificate is valid for a maximum of 5 years. There may be reasons for the government to issue a GMP or GDP certificate with a shorter validity period. Before the validity period expires, the healthcare inspectorate will conduct an inspection. This will assess whether the manufacturer/importer/distributor still meets the GMP or GDP requirements.

Submit your license application efficiently to ensure it's correct on the first attempt!

We know both sides of the story and focus on the essentials. This guarantees you a solid preparation and the best possible outcome. Thanks in part to PCS's international customer base, we can prepare companies for any type of inspection: EU GMP, U.S. FDA, PIC/S or WHO GMP; or a combination of these. We know what companies or government expects and what they are going to inspect.

  • Extensive GMP and GDP expertise
  • We know what the government inspects and expects
  • Within the Netherlands we have a 100% success rate
  • Our team of ex-EU inspectors and experts guide you from A-to-Z
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