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01 February 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 1 February 2013
As of 1 February 2013, the substances below are included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.
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31 January 2013 /Side effects and trials
Doctors in Denmark follow the recommendations for contraceptive pills
The French authorities recently asked the Pharmacovigilance Risk Assessment Committee (PRAC) to review the safety of the newer types of contraceptive pills (3rd and 4th generations). This follows the last couple of years' several investigations which have indicated that these pills carry a small increased risk of blood clots compared to the older versions (2nd generation). In Denmark, we have already taken steps to counter this increased risk
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31 January 2013 /Side effects and trials
France removes acne pills (Diane® Mite etc.) from the market
Following a review of effect and risk of blood clots, the French authorities have decided to remove cyproterone/oestrogen-containing medicines from the market within three months.
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30 January 2013 /Authorisation and supervision
Apply online for licensing of medicines via CESP
The pharmaceutical industry can now use a new online platform called CESP (Common European Submission Platform) to submit applications and material related to the licensing of medicines to the Danish Health and Medicines Authority. CESP reduces the administrative burdens of submitting and handling applications on CD/DVD for both the Danish Health and Medicines Authority and the industry, which is why we encourage applicants to switch to CESP submission.
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23 January 2013 /Authorisation and supervision
Register as a broker of medicinal products or as a manufacturer, distributor or importer of active substances in Denmark
The new directive on falsified medicinal products was implemented into Danish law on 1 January 2013 after a consultation process. Under the new rules, companies which broker medicinal products and companies which manufacture, import or distribute active substances in Denmark must register their activities with the Danish Health and Medicines Authority.
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17 January 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 20 December 2012
In this issue of Danish Pharmacovigilance Update: The Danish Health and Medicines Authority encourages doctors to be aware of suspected long-term adverse reactions from the use of SSRIs in children and adolescents.
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17 January 2013 /News - miscellaneous
Danish Pharmacovigilance Update, 15 November 2012
In this issue of Danish Pharmacovigilance Update: Chlorhexidine and the risk of anaphylactic reaction.
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15 January 2013 /Product information
Updating of summary of product characteristics prompted by changed ATC codes for 2013
We advise marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure that some ATC codes have changed in 2013.
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04 January 2013 /Side effects and trials
Answers to questions about post-authorisation safety studies
We have updated our questions and answers about clinical trials with further details about the so-called post-authorisation safety studies (PASS studies).
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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.
