Issuance of GMP certificates to pharmaceutical manufacturers and API manufacturers

Updated 19 January 2022

From 28 January 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 GMP-certificate is issued OMS ID is required.

It is therefore necessary that the company enter and maintain 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 GMP certificate or a statement of non-compliance with GMP within 90 days after a GMP inspection (inspection of good manufacturing practice). This is done in accordance with the agreed European procedures for inspectorates.

A GMP certificate is issued on the basis of a completed GMP inspection of a manufacturer operating in accordance with the EU GMP regulations. The certificate is issued provided that adequate documentation on the inspection follow-up is submitted.

The GMP certificate declares that the manufacturer complies with GMP, and the certificate includes a reference to the most recent date of the actual inspection, as well as which activities and under which legislation they have been inspected.

A GMP certificate is issued to a site and refers to one specific address. For each site, one GMP certificate can be issued per domain that has been inspected. GMP certificates are issued in a common EU format defined by the European Medicines Agency (EMA). The date of the certificate will be the date of issuance.

Danish pharmaceutical manufacturers (1) and registered API manufacturers (active substance manufacturers) are regularly inspected and will generally always have a valid GMP certificate.

Moreover, pharmaceutical manufacturers and to a limited extent API manufacturers outside Denmark are regularly inspected as part of the Danish Medicines Agency’s inspection programme in collaboration with other authorities in the EU; again GMP certificates are issued upon a completed inspection with an adequate follow-up.

At present, GMP certificates are not issued after an inspection at a hospital pharmacy or private pharmacy with magistral preparation where the medicines are only distributed in Denmark.

Validity

A GMP certificate is valid for three years from the most recent date of inspection, but the period of validity can be shortened under special circumstances. Since a GMP 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 GMP certificates and information on GMP non-compliance to the EMA’s database, EudraGMDP. In EudraGMDP, you can find GMP- and GDP-certificates and non-compliance statements for manufacturers and wholesale distributors throughout the world. You can also find company authorisations and API registrations for European manufacturers and wholesale distributors in the database.

The original and copies of the GMP certificate

The GMP certificate is issued in EudraGMDP and a signed pdf is sent to the contact person in the inspected company. GMP 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.

WHO GMP certificates

We only issue WHO GMP certificates (statement of GMP compliance) in extraordinary cases, e.g. if a special need arises from authorities in non-EU countries. We recommend that you use the company’s GMP certificate in the EMA format instead of requesting WHO GMP certificates.

Compilation of Community procedures

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

The format for GMP certificates is also available in the Compilated procedures, Union format for a GMP certificate.

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

 


1) Pharmaceutical manufacturers include manufacturers of medicinal products and intermediate products, including biological and sterile APIs.

 

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