News about Licensing and supervision
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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.
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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.
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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.
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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.
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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.
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Update on Europharma DK
| 03 February 2017 |
Europharma DK can now legally sell medicines repacked and released by Abacus Medicine.
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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.
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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).
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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.
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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.
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Twelve new substances on the list of euphoriant substances
| 30 November 2016 |
As of 24 November 2016, 12 new substances are included in the Danish 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.
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Available time slots for DCP applications with Denmark as reference member state
| 28 October 2016 |
Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available.
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Experts for the European Pharmacopoeia's groups of experts and working parties
| 07 October 2016 |
A very large part of the work related to the drafting of new monographs for the European Pharmacopoeia (EDQM) is carried out by external experts in 75 groups of experts and working parties. Experts for the groups are appointed for a period of three years, and the EDQM is now seeking experts for the period from 2017 to 2019.
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Manufacturers and wholesale distributors must be contactable outside opening hours
| 22 September 2016 |
The Danish Medicines Agency will make calls to companies' main phone numbers, or emergency lines, to check that wholesale distributors and pharmaceutical manufacturers are contactable outside normal opening hours and during holidays.
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All Danish Wholesale Distribution Authorisations now appear from EudraGMDP
| 16 September 2016 |
All Danish Wholesale Distribution Authorisations have been updated to the applicable European format and entered into the common EU database, EudraGMDP, which is available to the general public.
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New Danish member of the CHMP
| 06 September 2016 |
Sinan B. Sarac, Medical Doctor, is Denmark's new member of the CHMP, the European Medicines Agency's committee for the authorisation of medicines for human use.
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Improved access to patient data in clinical trials for monitors and GCP inspectors
| 05 September 2016 |
The Danish Medicines Agency's inspectors have direct access to health information in patient records in all clinical trials on medicinal products notified from 1 July 2016.
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More clinical trials in Denmark
| 09 August 2016 |
Last year, the Danish Medicines Agency received 329 applications for authorisation of clinical trials of medicines in humans – 45 applications more than in 2014. The figures appear from the Danish Medicines Agency’s annual report on clinical trials.
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Medicines tested by Semler are no longer sold in Denmark
| 04 August 2016 |
Medicines authorised on the basis of studies conducted by Semler are no longer sold on the Danish market.
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Marketing authorisation for medicine for cows suspended in the EU/EEA
| 20 July 2016 |
On 14 July 2016, the Committee for Medicinal Products for Veterinary Use (CVMP) recommended that the marketing authorisation for the centrally authorised medicinal product Velactis (cabergoline) be suspended temporarily. Velactis is used to reduce milk production in dairy cows at the time of drying off. The recommendation follows reports of serious adverse events after treatment with Velactis.