News items 2015
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Many addictive drugs lacked statutory packaging seal
| 08 June 2015 |
The Danish Health and Medicines Authority’s laboratory has made a thorough investigation and found that 70 of 229 addictive drugs in the Danish market lacked the statutory packaging seal on the outer packaging. The seal makes it easy to determine whether the package has been broken before it reaches the end user. The aim is to prevent abuse.
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Danish Pharmacovigilance Update, April 2015
| 08 May 2015 |
The April issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news:
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Annual Pharmacovigilance Report 2014
| 08 May 2015 |
In our annual pharmacovigilance report 2014, you can read about the development in the number of ADR reports, learn about various focus areas and the European collaboration in the pharmacovigilance area as well as see a selection of the ADR signals we processed in 2014, and much more.
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EMA's new assessment of the HPV vaccine: The benefits outweigh the risks
| 17 April 2015 |
A causal relationship between the dizziness and fatigue syndrome, Postural Orthostatic Tachycardia Syndrome (POTS) and Gardasil can neither be confirmed nor denied. The EU's group of pharmacovigilance experts have made a new assessment of the vaccine and still consider it to be safe.
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Danish Pharmacovigilance Update, March 2015
| 10 April 2015 |
The March issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
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New guidelines on good distribution practice for APIs
| 31 March 2015 |
The European Commission has published new guidelines on good distribution practice (GDP) for active substances (API) for medicinal products for human use.
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New management at the DHMA
| 16 March 2015 |
As from 13 March 2015, Jakob Cold has been appointed Acting Director General of the Danish Health and Medicines Authority. Anne-Marie Vangsted will continue as Director with special responsibility for the DHMA's supervision.
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Danish Pharmacovigilance Update, February 2015
| 16 March 2015 |
The February issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
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Else Smith to resign as Director General of the DHMA
| 16 March 2015 |
We confirm that as from 12 March 2015 Else Smith is no longer Director General of the Danish Health and Medicines Authority.
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Requirements for companies distributing and handling euphoriant substances
| 11 March 2015 |
We have gathered information about the requirements for authorisations, storage, accounting and reporting of euphoriant substances.
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Warning against Slimex 15 and Slimex 15 New Formula
| 09 March 2015 |
The Danish Health and Medicines Authority warns against taking the weight-loss products "Slimex 15" and "Slimex 15 New Formula" that are sold on the internet. The weight-loss products contain sibutramine that may cause serious side effects.
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Wholesale Distribution Authorisations and GDP certificates can now be transferred to EudraGMDP
| 09 March 2015 |
We can now transfer Wholesale Distribution Authorisations and Good Distribution Practice certificates to EudraGMDP, a Community database in the EU.
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The MMR vaccine is a safe vaccine
| 04 March 2015 |
We have reviewed the reported adverse reactions from the MMR vaccine during the past five years.
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Send Danish package leaflet when applying for changes to product information
| 11 February 2015 |
When applying for changes to the product information, marketing authorisation holders must always send a Danish version of the package leaflet to the Danish Health and Medicines Authority, whether the medicinal product is marketed in Denmark or not (unless the medicinal product is subject to section 11 about omission of the package leaflet, cf. Executive order no. 869 of 21 July 2011, as amended, on the labelling etc. of medicinal products).
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MIA format updated according to EMA's community procedures
| 11 February 2015 |
We have updated our IT systems and are now able to transfer Manufacturing and Importation Authorisations (MIA) to EudraGMDP via EMA's latest XML form. This implies some changes to how we will issue MIAs in future.
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Danish Pharmacovigilance Update, January 2015
| 10 February 2015 |
The January issue of Danish Pharmacovigilance Update with news from the EU, the DHMA and short news.
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New director at the DHMA
| 03 February 2015 |
On 1 February 2015, Anne-Marie Vangsted, Acting Head of Division, took up the position as Director with responsibility for supervision at the Danish Health and Medicines Authority. The new position as director was created as part of our action plan aimed at modernising the supervisory function, in which Anne-Marie Vangsted has played a key role since we presented the plan on 15 September 2014.
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Off-label use of medicines
| 30 January 2015 |
In a new report, the Danish Health and Medicines Authority highlights the monitoring of the safety of off-label use of medicines in Denmark.
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Digitisation of procedure for issuing export certificates for medicinal products
| 30 January 2015 |
We are simplifying the procedure for issuing export certificates for medicinal products. Previously, an export certificate was sent back and forth between the company and us by ordinary post. We are now simplifying and digitising the process.