GDP Certification in Denmark in Pharmaceutical product handlers must adhere to strict World Health Organization (WHO) criteria for safety and security to receive Good Distribution Practices (GDP) Certification. Although GDP certification is not a requirement globally, GDP compliance is required of EU pharmaceutical businesses and their logistical partners.
Importance of GDP Certification in Denmark
Pharmaceutical wholesale distribution is a crucial component of integrated supply chain management. When there is insufficient control, it can compromise the integrity and quality of pharmaceutical products. The Commission has released guidelines on good distribution practices for pharmaceuticals intended for human use to achieve this. GDP is a system of quality assurance that comprises rules for the acquisition, receipt, storage, and export of medications meant for human consumption.
The GDP governs the distribution and transportation of pharmaceutical products from the manufacturing facility, or another central location, to the final consumer or to a point in between, using various transport methods and passing via various storage and healthcare facilities.
Pharmaceutical companies must ensure that their products are distributed in a controlled environment. Wholesalers, shipping firms, storage facilities, and other supply chain partners must be carefully chosen. These organizations require continual supervision. CDG aims to offer a standardized system to audit GDP compliance at all supply chain levels.
Who is in charge of GDP certification in Denmark?
Within 90 days of a GDP inspection, the Denmark Medicines Agency issues a GDP certificate or a statement of non-compliance (inspection of good distribution practice). The established European inspectorate processes carry this out.
A wholesale distributor, an API distributor (distributors of active substances), or an API importer (importers of active substances) working in line with the EU GDP requirements will receive a GDP certificate once their GDP inspection is complete. The certificate will be granted if sufficient evidence regarding the inspection follow-up is produced.
The GDP certificate states that the business complies with GDP and lists which operations have been inspected and the most current date of the actual inspection. A site receives a GDP certificate that relates to a certain location. The certificate’s issue date will be that day.
Denmark wholesalers are frequently inspected, and they typically always possess a GDP certificate that is up to date. Since 2013, the Denmark Medicines Agency has provided wholesale distributors with GDP certificates.
After a GDP inspection, registered Denmark API distributors and importers will also be given a GDP certificate or a declaration of non-compliance with GDP.
No wholesale wholesalers, API distributors, or API importers outside of Denmark are subject to inspection by the Denmark Medicines Agency.
Validity
A GDP certificate is good for five years from the most recent inspection date, though it may be abbreviated in certain circumstances. A GDP certificate must be undertaken and finished with the proper follow-up to be renewed or reissued because it refers to a specific inspection.
Details for EudraGMDP
To the EMA’s database, EudraGMDP, we periodically send GDP certificates and details on non-compliance. The GDP certificates will be posted as they are produced, and all Denmark wholesale distribution authorizations and API registrations are currently accessible to the public via EudraGMDP. GDP certificates and non-compliance statements for wholesale distributors, API distributors, and European importers are available in EudraGMDP. Additionally, the database contains firm authorizations and API registrations for European manufacturers and wholesalers.
Original and copies of GDP certification in Denmark Â
The responsible individual or another contact person within the examined company will receive the GDP certificate electronically as a PDF document. The certificate is also posted to EudraGMDP at the same time. Certificates for GDP are not printed on paper. If the electronic version is inadequate, the Denmark Medicines Agency may offer assistance in issuing authorized copies of the GDP certificate.
When the GDP certificates are made available to the public in EudraGMDP, it will be possible to check the GDP status without ordering a copy of the certificate.
Sending an email can be used to order authorized copies. Send an email stating the certificate number of the certificate for which copies are being authorized, the number of copies being requested, and the name and address of the person inside the company to whom the copies are to be delivered. Businesses should refrain from printing copies and mail them to the Denmark Medicines Agency.
GDP certifications in Denmark are given out following the EMA’s compilation of community inspection and information-sharing procedures: the production and revision of GDP certificates.
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