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

From 2022 it is required, that companies are registered in EMAs Organisation Management Service (OMS), before the company can appear in a document in EudraGMDP.

When a GDP-certificate is issued OMS ID is required.

It is therefore necessary that the company enters and maintains their data in OMS. This has to be done before the certificate can be issued.

Please note, that the certificate per default is issued to the latest version of the OMS ID. In rare cases where the certificate has to be issued to an earlier version of the OMS ID, this has to be agreed with the inspector during the inspection.

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.

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 submit GDP certificates and information on GDP non-compliance to the EMA’s database, EudraGMDP. Danish wholesalers are regularly inspected and should under normal circumstances have a valid GDP-certificate at any given time. The Danish Medicines Agency has issued GDP-certificates for wholesalers since 2013.

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.

Issue of GDP-cerfificates

The GDP certificate is issued in EudraGMDP. GDP certificates are no longer issued in paper format.

The certificates can be verified directly in EudraGMDP instead of ordering authorized copies of the certificate.

However, the Danish Medicines Agency may help by issuing authorized copies of the GMP certificate in the rare cases where the electronic version is not adequate.

Authorized copies can be ordered by sending an email to Send an email. Attach the pdf files for the certificates of which an authorized copy is required. Please indicated 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. If the company does not have the pdf files a certificate number should be included in the email.

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
• 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.