GDP License and GDP certification

Services in accordance with the International GDP 2013/C 343/01 Regulations

Certification Experts can guide you in obtaining the GDP license and the compliance certificate by means of setting up a GDP Quality Management System (QMS). Additionally, our knowledge and (field) experience allows our GDP-experts to precisely gauge what your wholesale needs and we offer appropriate tools to assist wholesale distributors in conducting their activities in the distribution of medicinal products within the EEA, and training of your Responsible Person.

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Summary

A quick overview of this page

GDP meaning: Good Distribution Practice

The guidelines on Good Distribution Practice of medicinal products for human use are related to the safety and legality of the distribution of medicinal products. The implementation of this standard is inspected by the Health and Youth Care Inspectorate (IGJ) and states that you, as a wholesaler of medicinal products, must guarantee the quality of the medicine, during and after the distribution, for the users. Distribution of medicinal products refers to all activities consisting of procuring, holding, supplying or exporting medicinal products. Without a GDP license, you are not legally allowed to trade medicinal products within the European Economic Area (EEA).

Challenges GDP

A GDP-license can be obtained by demonstrating compliance with the GDP guidelines. The wholesale distributor must designate a Responsible Person (RP). The RP is responsible for the implementation of the GDP guidelines and must ensure that the guidelines remain met. The RP should have had training and thus appropriate competence, experience and knowledge of GDP in order to fulfil their role. Once you have been given the GDP license, you can start with GDP activities. Obtaining the certificate will depend on the implementation of a suitable GDP Quality Management System (QMS), applicable to the distribution of medicinal products.  

Guidance from start to finish

To ensure that you meet all the requirements, we will help you implement a suitable and complete GDP QMS. Additionally, we will perform internal audits to verify the compliance. We will train and support your RP, help you with temperature mapping, and set up a risk assessment for your GDP processes. Our (field) experience and expert knowledge will allow us to ensure that you will acquire the GDP license and eventually GDP-certificate, so you can safely trade your medicinal products within the EEA.

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GDP License and GDP certification

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What is GDP?

GDP is an abbreviation of Good Distribution Practice and refers to the EU-guidelines that have been created to ensure the product safety and product quality of medicinal products within the full supply chain, from manufacturer to patient, and to prevent counterfeit products. As a wholesale distributor of medicinal products, you are also responsible for realising a safe distribution process. To achieve this, you will have to meet the GDP requirements of medicinal products for human use. The full requirements and obligations are listed in the GDP-guideline 2013/C 343/01. Whether you are in full compliance with these regulations is inspected by the IGJ (Health and Youth Care Inspectorate). If you can prove your compliance during the IGJ- inspection, you will obtain a GDP license. From this moment forward, you are allowed to trade medicine within the EEA.

From a wholesale license to a GDP-certificate

The GDP-guidelines make it mandatory for wholesalers to assign a Responsible Person (RP) from the moment the company applies for the license. The RP bears the responsibility to guarantee that the wholesaler adheres to the applicable legislations and GDP-guidelines whilst you carry out your GDP activities. The RP needs to have full knowledge of GDP. The wholesaler should give the RP the defined authority, resources and responsibility needed to fulfil the duties. The RP may delegate (parts of) their duties but may not delegate responsibility. We can support your RP in the execution of their GDP related tasks.

Ensure and maintain your Quality!

GDP-process

The process of obtaining GDP-compliance is a process that can only be executed in practice. We can help you acquire your GDP-certificate in 5 steps:

  1. The GAP-analysis: The cost, time and tasks of the process can differ for each wholesaler. Performing a GAP-analysis, we will identify what needs to happen, what concerns there are, how long it will take and how much it will cost, so that you know exactly what lies ahead
  2. Implementation GDP-QMS: A GDP Quality Management System will indicate that the product safety and quality of the medicinal product is consistently protected, from manufacturer to patient, and prevents counterfeit products being traded. We can help you to set up and implement a suitable GDP-QMS to ensure that you meet all the requirements
  3. Internal audit: We perform an internal audit to check whether you are in compliance with the relevant GDP-guidelines and whether the processes of the QMS are being performed correctly. This way, you will be well prepared for the inspections by the IGJ
  4. Management review: The management review is performed directly after the internal audit, in which the management reviews the effectiveness of the QMS and decides the output requirements for improvement
  5. Inspection: The last step is the inspection by the IGJ. You will be inspected based on the implementation and execution of the GDP requirements. Our consultant can support you during this inspection, so we can help you answer all questions concerning the QMS

With a GDP-license, you are allowed to distribute medicinal products at all times, provided that this happens in compliance with your license. It is important to know that you cannot request for a GDP compliance certificate yourself. The certificate is granted only on the basis of an IGJ inspection for wholesalers with a GDP-license. The IGJ determines risk based, when which company will be inspected. Usually, this occurs 1-2 years after obtaining the GDP license.

GDP & FMD

In addition to having to take the GDP-guidelines into account, European legislation was introduced in February 2019 for prescription medicines (UR): Falsified Medicine Directive (FMD). These guidelines are intended to prevent counterfeit medicinal product from entering the production and supply chain. Since this date, every package of UR-medicine must bear two safety marks:

  • A unique 2D matrix code
  • Anti-Tamper Device (ATD)

Manufacturers must upload all 2D matrix information about their medicinal products to a European database: the EMVS (European Medicine Verification System). The unique 2D matrix codes that are applied onto the packaging are being verified in the NVMS (National Medicine Verification System) by every party in the supply chain so that medicinal products are traceable. The national database and the European database are linked.

ATD is intended to ensure that packages have not been opened during distribution and thus prevent falsification of medicinal products. As a party within the supply chain, you need the resources (NVMS, scanning equipment and procedures) to be able to comply with FMD regulations. We can prepare and guide you through this process.

I obtained my GDP-compliance certificate: now what?

Once you have obtained your GDP-compliance certificate, you can continue executing the GDP-activities. The GDP-certificate is valid for a maximum of 5 years. In a few instances, this may be shorter (risk based). To be able to ensure that the safety is consistently guaranteed and that the GDP-QMS remains up to date, new inspections will be held after this time period so you can maintain your certification. If you are no longer in compliance with the legislation after this period, the IGJ might have to take appropriate measures. This can vary from drawing up a CAPA-improvement plan that must be solved within an agreed time; a written warning or an administrative fine; or withdrawing/putting your GDP license on hold. Simultaneously, your activity can be instantly called to a halt and/or your medicinal product might be taken out of the trade immediately. You obviously want to prevent this from happening, which can be achieved by maintaining your QMS properly. Certification Experts can help you to set up and maintain a suitable GDP QMS. This way, you will remain in compliance with GDP for every inspection or audit.

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