Issuance of GMP certificates to pharmaceutical manufacturers and API manufacturers
10 March 2011, Updated 15 November 2013
The Danish Health and Medicines Authority 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 it will include a reference to the actual inspection, as well as which activities and under which legislation they have been inspected.
The date of the certificate will be the last date of the inspection. Each site receives one GMP certificate and for each site, a GMP certificate is issued per domain inspected (1). The GMP certificates are issued in a common EU format defined by EMA (European Medicines Agency).
Danish pharmaceutical manufacturers will be regularly inspected and will generally always have a valid GMP certificate.
Danish API manufacturers (manufacturers of active pharmaceutical ingredients) should request an inspection at the latest six months before the current GMP certificate expires, in order to maintain a valid GMP certificate at any time. As stated in our questions and answers, we do not routinely inspect API manufacturers, but we do inspect manufacturing sites upon request.
Moreover, finished product manufacturers and API manufacturers outside Denmark are regularly inspected as part of the Danish Health and Medicines Authority's inspection programme in collaboration with other authorities in the EU; again GMP cerficates 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 small scale preparation where the medicines are only distributed in Denmark. Nor are GMP certificates issued to feed mills (manufacturers of medicated feed) because medicated feed export will require an accompanying certificate from the Danish Health and Medicines Authority.
A GMP certificate can be valid for three years at the most, but the period of validity can be shortened under special circumstances. Because a GMP certificate refers to a specific inspection, it cannot be renewed or reissued before a new inspection is conducted and completed with adequate follow-up.
Information to EudraGMP
All GMP certificates as well as information on GMP non-compliance are regularly submitted to the EMA database, EudraGMP. Today, all Danish manufacturing authorisations are publicly available
in EudraGMP. The Danish Health and Medicines Authority is continuously working to transfer the latest GMP certificates for all authorised Danish manufacturers as well as inspections conducted outside Denmark to 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 the contact person in the inspected company. At the same time, the certificate is uploaded in EudraGMDP. Printed GMP certificates are no longer issued. However, the Danish Health and Medicines Authority may help to issue authorised copies of the GMP certificate if the electronic version is not adequate.
As soon as the GMP certificates are available in EudraGMDP, the GMP 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 email@example.com. stating the certificate number of the certificate of which 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. The companies must not print the copy themselves and send it to the Danish Health and Medicines Authority.
WHO GMP certificates
Because the WHO GMP certificates H5-204, H5-205, H5-206, H5-207, H5-208 and H5-210 should not be used in the EU, concurrent issuance of these types of WHO GMP certificates will be phased out because of the issuance of GMP certificates conformant to the EMA format. If a special need arises from authorities in non-EU countries, the Danish Health and Medicines Authority will issue the WHO GMP certificates requested.
Compilation of Community procedures
GMP certificates are issued in accordance with the EMA Compilation of Community procedures on inspections and exchange of information: The issue and update of GMP certificates.
The format for GMP certificates is available in the EMA Compilation of Community procedures on inspections and exchange of information: Community format for a GMP certificate.
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) Medicinal products also refer to biological and sterile API, intermediate products as well as medicines for export.Source: sundhedsstyrelsen.dk