Issuance of GDP certificates to wholesale distributors, API distributors and API importers

07 October 2016

The Danish Medicines Agency issues a GDP certificate or a statement of non-compliance with GDP within 90 days after a GDP inspection (inspection of good distribution practice). This is done in accordance with the agreed European procedures for inspectorates.

A GDP certificate is issued on the basis of a completed GDP inspection of a wholesale distributor, an API distributor (distributors of active substances) or an API importer (importers of active substances) operating in accordance with the EU GDP regulations. The certificate is issued provided that adequate documentation on the inspection follow-up is submitted.

The GDP certificate declares that the company complies with GDP, and the certificate includes a reference to the most recent date of the actual inspection, as well as which activities have been inspected. A GDP certificate is issued to a site and refers to one specific address. The date of the certificate will be the date of issuance.

Danish wholesale distributors are regularly inspected and will generally always have a valid GDP certificate. The Danish Medicines Agency has issued GDP certificates to wholesale distributors since 2013.

Registered, Danish API distributors and API importers will also receive a GDP certificate or a statement of non-compliance with GDP after a completed GDP inspection.

The Danish Medicines Agency does not inspect wholesale distributors, API distributors or API importers outside Denmark.

Validity

A GDP certificate is valid for five years from the most recent date of inspection, but the period of validity can be shortened under special circumstances. Since a GDP certificate refers to a specific inspection, it cannot be renewed or reissued until a new inspection is conducted and completed with adequate follow-up.

Information to EudraGMDP

We regularly submit GDP certificates and information on GDP non-compliance to the EMA’s database, EudraGMDP. At present, all Danish wholesale distribution authorisations and API registrations are publicly available at EudraGMDP, and GDP certificates will be uploaded as they are issued. In EudraGMDP, you can find GDP certificates and non-compliance statements for wholesale distributors and API distributors and importers in Europe. You can also find company authorisations and API registrations for European manufacturers and wholesale distributors in the database.

The original and copies of the GDP certificate

The GDP certificate is issued as a PDF document and sent electronically to the responsible person or another contact person in the inspected company. At the same time, the certificate is uploaded to EudraGMDP. GDP certificates are not issued in paper format. However, the Danish Medicines Agency may help to issue authorised copies of the GDP certificate if the electronic version is not adequate.

As soon as the GDP certificates are publicly available in EudraGMDP, the GDP status can be verified directly in the system instead of ordering a copy of the certificate.

Authorised copies can be ordered by sending an email to certificates@dkma.dk, stating the certificate number of the certificate of which authorised copies are requested, how many copies are requested, as well as to whom in the company (name and address) the copies are to be sent. Companies should not print the copy themselves and send it to the Danish Medicines Agency.

Compilation of Community procedures

GDP certificates are issued in accordance with the EMA’s Compilation of Community procedures on inspections and exchange of information: The issue and update of GDP certificates.

The format for GDP certificates is also available in the Compilated procedures: Union Format for a Good Distribution Practice certificate and Union Format for a Good Distribution Practice Certificate for Active Substances to be used as Starting Materials in Medicinal Products for Human Use.

You can find the Community procedures in a complete PDF file at the EMA’s website under Community procedures.

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