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New Director of Division for Pharmacovigilance & Medical Devices
| 03 November 2017 |
Jens Piero Quartarolo has been appointed new Director of Division for Pharmacovigilance & Medical Devices and will form part of the Danish Medicines Agency's leadership team.
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Keep up with the latest updates on our website
| 27 October 2017 |
Now you can keep up with all updates on the Danish Medicines Agency's website and not only our news items. You can filter the overview by category and month, and the overview is structured in chronological order with the latest update first. You can find a shortcut to the overview on our home page.
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Self-selection of OTC medicines for human use
| 25 October 2017 |
On 1 January 2018, new rules on self-selection of OTC medicines become effective. With the change in law, certain OTC medicines will be available for self-selection, which means that they can be sold from shop areas and not only at the counter.
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The Danish Medicines Agency contributes to review of Chinese medicines act
| 10 October 2017 |
On Monday 9 October, a Chinese delegation headed by Xu Jinghe visited the Danish Medicines Agency. Xu Jinghe is Director General of the CFDA's Department of Legal Affairs and one of the main architects of the renewal of the Chinese medicines legislation.
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DKMA Update October 2017
| 10 October 2017 |
In this issue of DKMA Update, you can read about the decision to change the dispensing status of a number of opioids, about the new guidelines on medicinal cannabis for doctors, and about the executive order on the import of cannabis products.
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Collection of scientific experience for medicinal cannabis pilot programme
| 05 October 2017 |
One or more research projects should be carried out for the purpose of gathering scientific experience on medicinal cannabis. The projects will form part of the medicinal cannabis pilot programme.
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New practice for follow-up information on adverse reaction reports
| 29 September 2017 |
The Danish Medicines Agency has introduced a new practice for the processing of pharmaceutical companies' requests for follow-up information on reports of suspected adverse reactions.
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Global operation against illegal medicines
| 25 September 2017 |
A global operation against illegal medicines has been completed. 123 countries participated, and the operation resulted in 354 arrests or further investigations and the suspension of more than 3,500 websites.
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Decisions on marketing authorisations will be sent electronically to Danish recipients from October 2017
| 20 September 2017 |
From 1 October 2017, the Danish Medicines Agency's licensing division will send decisions on marketing authorisations (including any annexes) to Danish recipients and companies by digital post.
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E2B acknowledgment format change
| 12 September 2017 |
Companies that use the Danish Medicines Agency's Pharmacovigilance System should be aware that we have changed the MessageFormatRelease value from 2.0 to 1.0.
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DKMA Update
| 11 September 2017 |
Our newsletter Danish Pharmacovigilance Update changes name to DKMA Update and will from now on contain information about medicinal products in general, patient safety and life science.
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Testing the exchange of E2B files
| 16 August 2017 |
Testing the exchange of E2B ICSRs/SUSARs between the Danish Medicines Agency and companies/sponsors must be completed by Friday 29 September 2017.
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Bravecto® may cause convulsions in dogs on rare occasions
| 10 August 2017 |
The European Medicines Agency has reviewed the adverse events of Bravecto®, a veterinary medicine used to treat flea and tick infestations in dogs. The conclusion is that the medicine may on very rare occasions cause convulsions in dogs – primarily in dogs with pre-existing epilepsy.
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Withdrawal of one more batch of counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 01 August 2017 |
German and Danish parallel importers and the Danish Medicines Agency are now withdrawing the fourth batch of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batch contains counterfeit packs.
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Counterfeit packs of the schizophrenia medicine Xeplion 150 mg
| 27 July 2017 |
One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.
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Adverse reaction reports received from the Danish Patient Compensation Association
| 14 July 2017 |
The marketing authorisation holder of a medicinal product shall not submit reports to the Danish Medicines Agency about any adverse reactions appearing from decisions about compensation for medicinal injuries, which the company has received from the Danish Patient Compensation Association.
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The European Commission's decision concerning veterinary medicinal products containing zinc oxide
| 06 July 2017 |
On 26 June 2017, the European Commission adopted a decision to withdraw all marketing authorisations for veterinary medicinal products containing zinc oxide administered orally to food producing species. The medicinal products affected by the decision appear from Annex I to the decision.
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New fees for medicinal products, pharmaceutical companies and clinical trials from 1 July 2017
| 03 July 2017 |
On 1 July 2017, a new executive order on fees payable for medicinal products, pharmaceutical companies and clinical trials became effective. The new fees involve changes in a number of areas.
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Adverse event reports for centrally authorised veterinary medicinal products should not be sent to the DKMA
| 03 July 2017 |
The Danish Medicines Agency no longer requests the direct transfer of serious and unexpected third-country adverse event reports for centrally authorised veterinary medicinal products.
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Substantial progress in cooperation with CFDA only six weeks after state visit
| 23 June 2017 |
During the official state visit at the beginning of May, the Chinese and Danish Ministers for Health and Food signed a Memorandum of Understanding about the establishment of the China-Denmark Food and Drug Regulatory Cooperation Centre. Only six weeks after the state visit, the China Food and Drug Administration (CFDA) and the Danish Medicines Agency held a successful seminar on 20 and 21 June in Beijing on the licensing of medicines and the drafting of a work programme with common activities up to and including 2020.
