GDP supervision
The Dutch Health and Youth Care Inspectorate (IGJ) monitors the entire distribution chain for medicinal products. If the quality of the medicinal products in the distribution chain from manufacturer to patient is to be guaranteed, manufacturers and wholesalers must comply with the stricter rules for Good Distribution Practices (GDP).
Certificates automatically extended for a fourth time until the end of December 2024
Certificates held by medicinal product manufacturers and permit holders are being automatically extended for a fourth time. The extension is until the end of December 2024. In issuing this extension, the Health and Youth Care Inspectorate is following the policy of the European Medicines Agency (EMA). There are exceptions for certificates with an expiry date specified in the clarifying remarks, and where there are changes in the scope of the GMP/GDP certificate (such as new buildings or new medicinal products).
Medicinal products in the Netherlands nowadays come from all over the world, with all the concomitant risks. The GDP norm was amended in 2013 as a result. This new norm, which is replacing the GDP standard from 1994, imposes additional requirements on the logistics of medicinal products and also gives more guarantees that the medicinal products that the patients use are of good quality. More information about the precise changes is given in ‘Vragen over de EU-richtsnoer goede distributiepraktijken (GDP)’ (Questions about the EU GDP guideline, in Dutch).
Representatives and staff of pharmaceutical and logistics companies discussed the norm at a congress on 2 September 2013.Read the congress report here.
Inspections
The IGJ carries out periodic inspections at all medicinal product distributors and importers in the Netherlands. During those inspections, which sometimes take several days, the IGJ checks whether distributors and importers are complying with the GDP guidelines. The IGJ will be busy until 2018 carrying out a round of inspections at all pharmaceutical companies to inspect them against the new norm.
For the manufacturers, a GDP inspection is generally combined with a GMP inspection.
Check before applying for a certificate: is the OMS data correct?
When wholesale distribution authorisations are issued, they are based on the data about your organisation stored in the Organisation Management Service (OMS) database of the European Medicines Agency (EMA). This will be the standard from 28 January 2022.
Accordingly, before you submit your application you should check that your data in the Organisation Management Service (OMS) database is correct. If it is, you can apply to Farmatec for a new or updated wholesale distribution authorisation.
This applies to manufacturers, importers, distributors and wholesalers of medicinal products and the active substances they contain.
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