News about Licensing and supervision
-
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.
-
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.
-
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.
-
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One German and several Danish parallel importers and the Danish Medicines Agency have withdrawn several batches of Xeplion 150 mg from wholesale distributors, hospitals and pharmacies, because the batches contained counterfeit packs.
-
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.
-
Eleven new substances on the list of euphoriant substances
| 16 June 2017 |
On 15 June 2017, 11 new substances were included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health. The information is primarily relevant to companies authorised to deal with euphoriant substances.
-
New format requirements for marketing authorisation applications
| 15 June 2017 |
The Danish Medicines Agency is postponing the phasing-out of NeeS and tightens the format requirements for updating the assessment report prior to MRP/RUP.
-
Annual report 2016 - Clinical trials of medicines
| 13 June 2017 |
LLast year, the Danish Medicines Agency received 286 clinical trial applications. This is a small decline compared to 2015. However, the number of clinical trial applications has remained stable at around 300 applications per year since 2013.
-
More batches of EpiPen® are withdrawn
| 06 April 2017 |
MEDA has decided to withdraw four more batches of EpiPen®. The withdrawal concerns two batches of EpiPen® 300 micrograms/dose and two batches of EpiPen® Jr 150 micrograms/dose. The latter is used for acute hypersensitivity reactions in children. The reason for the withdrawal is that there is a risk that the auto-injector does not work.
-
Withdrawal of a batch of EpiPen® 300 micrograms
| 17 March 2017 |
MEDA recalls a batch of the adrenaline product EpiPen® 300 micrograms/dose, which is used for sudden allergic reactions. There is a risk that the auto-injector does not work. The withdrawal concerns product number 578818 with batch number: 5FA665B and expiry date 03/2017.
-
EuropharmaDK regains its authorisation
| 13 March 2017 |
The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.
-
New transatlantic agreement on mutual recognition of inspections
| 03 March 2017 |
The EU and the USA have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic.
-
Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets
| 21 February 2017 |
Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.
-
New Q&A for clinical trial sponsors regarding contractual arrangements with vendors for electronic systems
| 13 February 2017 |
The Good Clinical Practice (GCP) inspectors of the EU member states have published a new Q&A based on the pitfalls for sponsors to be aware of regarding contractual arrangements with vendors for electronic systems in connection with clinical trials.
-
Denmark bids to host EMA headquarters in Copenhagen
| 08 February 2017 |
Today, the Danish Government officially announced its candidacy for hosting the European Medicines Agency (EMA) in Denmark.
-
Update on Europharma DK
| 03 February 2017 |
Europharma DK can now legally sell medicines repacked and released by Abacus Medicine.
-
Updating of summaries of product characteristics due to changed ATC codes for 2017
| 20 January 2017 |
Marketing authorisation holders of medicinal products authorised under the national procedure, the decentralised procedure as well as the mutual recognition procedure should be aware that some ATC codes have been changed for 2017.
-
Suspension of Europharma DK ApS’ authorisation to manufacture and distribute parallel imported medicinal products
| 03 January 2017 |
Today, 3 January 2017, the Danish Medicines Agency suspended Europharma DK ApS’ authorisation number 30308 issued on 23 March 2015 for the manufacturing and import of medicinal products and intermediate products (GMP authorisation).
-
Zinc oxide for young pigs to be phased out
| 19 December 2016 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) has recommended to the European Commission that medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs should be withdrawn from the market.
-
Phasing-out of the NeeS format for applications for marketing authorisations of medicinal products
| 12 December 2016 |
Due to an increasing number of requests, we would like to point out the phasing-out plan for NeeS and the transition to eCTD/VNeeS as outlined in the eSubmission Roadmap. The format requirements apply to applications for marketing authorisations for medicinal products as well as maintenance of these (variations, renewals etc.). The changes do not apply to parallel import and parallel distribution.