For pharma & biotech

Certificates for the pharmaceutical industry

GDP and GMP certificates are certificates especially for the pharmaceutical industry. These are certificates that are extra difficult to apply for. Unlike ISO or HACCP certificates, GMP and GDP certificates are issued by government bodies / regulatory authorities.

In the Netherlands, GMP and GDP certificates are issued by Farmatec. Farmatec provides pharmaceutical licenses, approvals, exemptions and registrations for pharmaceuticals and medical devices for, for example, the pharmaceutical industry.

To avoid delays in the application or change process of a GMP or GDP certificate, 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 registration form.

Example of an EU GMP certificate issued by the Dutch regulatory inspectorate
An example of an EU GMP certificate.

Which requirements do you have to meet for GDP and GMP certification?

To be able to produce, transport or import medicines, your company needs a GMP or GDP certificate and permit. In order to obtain a licence, an application is submitted to Farmatec, who assess the license application in consultation with the Health Care and Youth Inspectorate (IGJ). After this, the IGJ carries out a GMP or GDP inspection. If the result is good, your company will receive a GMP or GDP certificate.

In order to meet the requirements for a GMP or GDP certificate, a company must meet a number of requirements;

  • The company has implemented the Good Manufacturing Practice (GMP) or Good Distribution Practice (GDP) legislation,
  • The company may manufacture, distribute, store or import the intended drugs,
  • The supply chains have been carefully mapped out and are transparent,
  • An inspection can take place at the company; both the quality system and the facility/office are operational,
  • A license application is pending with Farmatec (or the company already has a license),

GMP & GDP licensing whitepapers

Whitepaper
Manufacturing & Import Authorization

Learn more about GMP licensing, certification and how you can obtain a Manufacturing and Import Authorization (MIA)

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Whitepaper
Wholesale & Distribution Authorization

Learn more about GDP licensing, certification and how you can obtain a Wholesale Distribution License (WDL)

Download whitepaper!

What is a GMP certificate?

A GMP certificate is a certificate that shows that your company complies with Good Manufacturing Practice (GMP) and thus meets the requirement of the Ministry of Health to import medicinal products into the EU. If you are GMP certified, you can import and produce medicines.

It also gives your company the ability to manufacture and market medicines in countries. This means that medicines can be sold in the European Union, or that they can be exported to countries outside the EU.

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.

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 the WHO, companies must go through WHO prequalification (WHO PQ) and comply with the WHO GMP.

As a rule, a GMP certificate is valid for a maximum of 5 years. There may be reasons for the Health Care and Youth Inspectorate to issue a GMP certificate with a shorter period of validity. Before the validity period has expired, the IGJ will carry out an inspection. In this it is assessed whether the manufacturer/importer still complies with the GMP and the requirements of the registration dossier.

What is a GDP certificate?

When a logistics organization is GDP certified, the company is allowed to store and trade medicines. The quality of a medicine must also be guaranteed after the medicine has left the factory. That is why licensing requirements have been drawn up for the storage, transport and delivery of medicines.

The GDP certification is intended for logistics organizations that store medicines for longer than 72 hours, or have outsourced their storage. With a GDP certificate, a company meets the Good Distribution Practice (GDP) requirements. It is not allowed to produce or import medicinal products under a GDP certificate or GDP permit. A GMP certificate and GMP permit are required for this.

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.

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. There is no separate GDP guideline in the United States. National governments do, however, enforce principles comparable to the principles of the EU GDP. Think of quarantine requirements, pest control and temperature controlled transport.

GDP certificates have a maximum validity of five years. In some cases, a GDP certificate with a shorter validity period is issued by the Health Care and Youth Inspectorate (IGJ). As a rule, the IGJ carries out a GDP inspection of the wholesaler for the certificate. This inspection can take place at any time towards the end of the GDP certificate.

Why use the services of PCS when requesting certificates?

Applying for or changing a permit 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 permit processes to good results. If desired, PCS can submit the license application to the government and conduct the subsequent correspondence. You will be completely relieved of this.