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21 December 2012 /Authorisation and supervision
Changes affecting company authorisations and new registrations of companies
The implementation of directive 2011/62/EU of 8 June 2011 on falsified medicines implies changes to company authorisations. At the same time, the concept of wholesale distribution becomes broader and will in future cover distribution (purchase and sale) of medicinal products whereas before the physical handling of medicinal products was the pivotal element in the granting of wholesale dealer's authorisations (GDP).
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20 December 2012 /Retail and online sale
Warning against VigRX TM For Men and Viapro
The Danish Veterinary and Food Administration and the Danish Health and Medicines Authority warn against a number of products that are illegal and potentially dangerous to consumers' health. The products include both food supplements and unauthorised medicines.
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20 December 2012 /Authorisation and supervision
Time slots for marketing authorisation applications through the decentralised procedure in 2013
From January 2013 to 31 January 2013 (both days included) companies can request time slots for April, May and June 2013 for submission of applications.
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18 December 2012 /About us
Merry Christmas and happy New Year
Thank you for your cooperation and dedication in 2012. We wish you all a merry Christmas and a happy New Year.
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17 December 2012 /About us
New EAN number and CVR number from 1 January 2013
From 1 January 2013, the Danish Health and Medicines Authority will have a common CVR number and EAN number, which replace the previous numbers of the former National Board of Health and the Danish Medicines Agency.
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10 December 2012 /Authorisation and supervision
New guideline: renewal of marketing authorisation for nationally authorised medicinal products
The documentation to be submitted with an application to renew a marketing authorisation for nationally authorised medicinal products now follows the rules which apply to the mutual recognition procedure and the decentralised procedure. Likewise, an application for renewal of a marketing authorisation must be made using the EU form.
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07 December 2012 /Authorisation and supervision
Annual report on human tissues and cells 2011
The annual report for human tissues and cells for 2011 has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by tissue establishments and gynaecology clinics in Denmark in the period January to December 2011.
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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.
