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27 November 2012 /Authorisation and supervision
Companies required to check company authorisation on receipt of medicinal products
Pursuant to section 20 of the Danish GDP executive order, companies must ensure, as part of their receipt control activities, that they only receive medicinal products from companies which hold a valid company authorisation or from pharmacies.
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20 November 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of – donepezil
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for donepezil-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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20 November 2012 /News - medical devices
21 December is final date for submission of clinical investigation applications in 2012
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical investigations in 2012 must be received by 21 December 2012. Applications received after this date will be considered received on 2 January 2013.
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16 November 2012 | Updated 16 November 2012 /Side effects and trials
21 December is final date for submission of clinical trial applications in 2012
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical trials in 2012 must reach us by 21 December 2012. All applications that we receive after this date will be considered received on 2 January 2013.
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15 November 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 18 October 2012
In this issue of Danish Pharmacovigilance Update, read about: Risk of developing hepatotoxicity in patients undergoing treatment with agomelatine (Valdoxan®)
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09 November 2012 | Updated 13 November 2012 /Authorisation and supervision
Withdrawal of older medicines in Denmark
A current debate in the Danish media has focused on the withdrawal of a number of older medicines, and we here give a status on the medicines concerned. In 2002, the former Danish Medicines Agency was approached by the Association of Danish Pharmacies concerning 23 named medicines which were all authorised long before the introduction of the first Danish Medicines Act in 1976, mainly in the 1950s.
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05 November 2012 /Side effects and trials
European Medicines Agency has started review of codeine-containing medicines
On 3 October 2012, the European Medicines Agency (EMA) started a review of codeine-containing medicines. Codeine-containing medicines are used for pain relief in adults and children. Codeine is to a limited degree converted into morphine in the body. It is well-known that some patients convert codeine to morphine at a faster rate than others, resulting in higher than normal levels of morphine in their blood. This may cause side effects such as breathing difficulties.
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02 November 2012 /Authorisation and supervision
Deadline for submission of licensing applications in 2012
The last day for submission of medicines licensing applications and other documentation in 2012 is Friday 21 December 2012.
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01 November 2012 /About us
No access to e-forms on Sunday 4 November from 4 to 5 pm
A number of the Danish Health and Medicines Authority’s e-forms cannot be accessed on Sunday 4 November from 4 to 5 pm.
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25 October 2012 | Updated 26 October 2012 /Product areas
Criticism of CE marking of medical devices in Czech Republic and Slovakia
The Danish Health and Medicines Authority has asked the European Commission to take action in a case concerning whether two named notified bodies in the Czech Republic and Slovakia comply with EU medical devices law.
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26 October 2012 /Authorisation and supervision
New, higher-strength insulin on the way
The European Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended last week that a new analogue insulin can be marketed in the strengths of 100 units/ml and 200 units/ml. The strength of 100 units/ml has for many years been the only strength available for all insulin products. But from the beginning of 2013, it is expected that the new, higher-strength version will be marketed in Europe, and other insulin products of strengths higher than 100 units/ml are expected to be on the way as well.
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26 October 2012 /News - medical devices
Criticism of CE marking of medical devices in Czech Republic and Slovakia
In cooperation with the British Medical Journal, the Daily Telegraph reported today that two named notified bodies in the Czech Republic and Slovakia do not comply with EU medical devices law. It appears from the articles that companies can have their medical devices certified by the notified bodies based on a hasty and superficial evaluation. It is also claimed that companies can have products certified that resemble products which have been removed from the market because of safety problems.
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19 October 2012 /Side effects and trials
The Danish Health and Medicines Authority maintains influenza vaccine recommendation
The European Medicines Agency, EMA, has reviewed a hypothesis on Pandemrix® and the development of sleep attacks (narcolepsy). Overall, EMA assesses that there are no grounds for concerns regarding Pandemrix® and other vaccines, including influenza vaccines.
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19 October 2012 /Side effects and trials
Benefits of NSAIDs still outweigh risks - but diclofenac may be associated with a small increased risk of side effects
In October 2011, the Committee for Medicinal Products for Human Use (CHMP) decided to review the newest data on cardiovascular side effects from analgesics (painkillers) of the NSAID type. The conclusions are now available, and they confirm the previous conclusions from 2005 and 2006 that the benefits of NSAIDs still outweigh the risks.
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17 October 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 20 September 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.
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16 October 2012 /News - medical devices
European Commission proposes two new regulations on medical devices and in vitro diagnostic devices
The European Commission has proposed two new regulations on medical devices and in vitro diagnostic devices. This launches the European Union's (EU) legislative decision-making process
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15 October 2012 /Side effects and trials
The Danish Health and Medicines Authority still recommends influenza vaccine
The Danish Health and Medicines Authority still recommends using the Fluarix® seasonal flu vaccine for people who are in a risk group.
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15 October 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of dopamine agonists, levodopa and COMT inhibitors
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for dopamine agonists, levodopa and COMT inhibitors. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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10 October 2012 /News - miscellaneous
Contaminated medication possibly linked to several meningitis outbreaks in the USA
The health authorities in the USA are presently investigating the cause of a large number of meningitis outbreaks caused by the fungus Aspergillus. In the USA, only those who received the medication in question have been infected, and there have been no reports of transmission from persons to person.
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05 October 2012 /News - miscellaneous
Warning against illegal potency enhancers
The Danish Health and Medicines Authority warns against widespread sale of illegal potency enhancers. Over the first nine months of 2012, the Danish Health and Medicines Authority was made aware of 54 illegal potency-enhancing products found to contain active pharmaceutical ingredients not declared anywhere on the package or in the product information. The findings are a result of international cooperation.
