PCS offers you practical support in obtaining or changing your certificate. GMP and GDP certificates deserve special attention. Need help obtaining or changing your certificate? Please contact us. We'd be happy to help you!
For pharma & biotech
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.
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;
Learn more about GMP licensing, certification and how you can obtain a Manufacturing and Import Authorization (MIA)Download whitepaper!
Learn more about GDP licensing, certification and how you can obtain a Wholesale Distribution License (WDL)Download whitepaper!
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.
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.
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.