Issuance of GMP certificates to pharmaceutical manufacturers and API manufacturers

Updated 10 January 2017

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(1) 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(2) 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. Nor are GMP certificates issued to manufacturers of medicated feed. Medicated feed export requires an accompanying certificate from the Danish Medicines Agency.

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 regularly submit GMP certificates and information on GMP non-compliance to the EMA’s database, EudraGMDP. In EudraGMDP, you can find GMP certificates and non-compliance statements for manufacturers 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 as a PDF document and sent electronically to the qualified person or another contact person in the inspected company. At the same time, the certificate is uploaded to EudraGMDP. GMP certificates are no longer issued in paper format. However, the Danish Medicines Agency may help to issue authorised copies of the GMP certificate if the electronic version is not adequate.

We recommend that the GMP certificates are verified directly in EudraGMDP instead of ordering authorised copies 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.

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) A GMP certificate will refer to one domain, i.e. a Directive. In Denmark, inspections are carried out within the following domains.

  • Art. 40 of Directive 2001/83/EC: inspection of human medicinal products(2)
  • Art. 44 of Directive 2001/82/EC: inspection of veterinary medicinal products(2)
  • Art. 13 of Directive 2001/20/EC: inspection of investigational medicinal products(2)
  • Art. 111 of Directive 2001/83/EC: inspection of human chemical API
  • Art. 80(1) of Directive 2001/82/EC: inspection of veterinary chemical API

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

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