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News about licensing of medicines
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03 June 2013
EMA recommends restrictions in the use of Trobalt
The Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommends restricting the use of the epilepsy medicine Trobalt® (retigabine) to only those patients for whom other anti-epileptic medicines have proved inadequate or have not been tolerated.
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03 May 2013
Application for parallel import from Croatia
On 1 July 2013, Croatia joins the EU after which it will be possible to apply for parallel import with Croatia as import country.
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05 April 2013
Updating of summary of product characteristics prompted by changed ATC codes for 2013
We advise marketing authorisation holders of veterinary medicinal products authorised under the decentralised procedure and the mutual recognition procedure that some ATC codes have changed in 2013.
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03 April 2013
Text on reporting of adverse reactions in SPC and PL
In connection with the pharmacovigilance legislation from 2011, which entered into force in the summer 2012, a requirement was introduced for the summary of product characteristics and the package leaflet of human medicinal products to include a text encouraging the reporting of suspected adverse reactions in compliance with the applicable national reporting system. In regard to the text in the package leaflet, the Danish Health and Medicines Authority is planning an amendment of the Danish executive order on labelling to extend the deadline for implementation of the executive order's section 35(3) for medicinal products authorised on or before 20 July 2012.
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30 January 2013
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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20 December 2012
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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10 December 2012
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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20 November 2012
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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09 November 2012 | Updated 13 November 2012
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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02 November 2012
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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26 October 2012
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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15 October 2012
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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21 September 2012
Danish translation of the CMDh's recommendation for the product information of gabapentin
The CMDh has prepared a recommendation for the wording of the product information for gabapentin-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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21 September 2012
Danish translation of the PhVWP's recommendation for the product information of allopurinol
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for allopurinol.
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21 September 2012
Danish translation of the PhVWP's recommendation for the product information of risedronate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for risedronate. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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21 September 2012
Danish translation of the PhVWP's recommendation for the product information of tramadol
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for tramadol-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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20 September 2012
Time slots for marketing authorisation applications through the decentralised procedure in 2013
From 1 October 2012 to 31 October 2012 (both days included) it will be possible to request time slots for January, February and March 2013 for submission of marketing authorisation applications.
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28 August 2012
Danish translation of PhVWP's recommendation for the product information - oxcarbazepine (Trileptal)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for oxcarbazepine.
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28 August 2012
Danish translation of the PhVWP's recommendation for the product information - carbamazepine
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine.
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10 August 2012
Closer attention to guidelines on submission of electronic applications for marketing authorisations
Our guidelines on submission of electronic applications to the Danish Health and Medicines Authority have been available on our website for some time, but we wish to draw attention to them once again As we have received a number of incorrect submissions.
