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Chinese delegation is visiting the Danish Medicines Agency today
| 13 March 2017 |
The Danish Medicines Agency and the Chinese Food and Drug Administration, CFDA, take another big step towards closer cooperation.
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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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Danish Pharmacovigilance Update, February 2017
| 06 March 2017 |
The February issue of Danish Pharmacovigilance Update.
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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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Danish Pharmacovigilance Update, January 2017
| 03 February 2017 |
The January issue of Danish Pharmacovigilance Update.
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We are extending our opening hours
| 31 January 2017 |
From Wednesday 1 February 2017, we are extending our opening hours. This means that the reception will be open Monday to Friday from 8.30am to 3.30pm. You can also call us on our main telephone number during these hours.
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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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Danish Pharmacovigilance Update, December 2016
| 06 January 2017 |
The December issue of Danish Pharmacovigilance Update.
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Re-examination of the CVMP's decision to phase out zinc oxide for young pigs
| 05 January 2017 |
The European Medicines Agency's Committee for Medicinal Products for Veterinary Use (CVMP) will re-examine the decision to phase out medicinal products containing zinc oxide for the prevention of diarrhoea in young pigs.
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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).
