Share
News
-
03 May 2013 /Authorisation and supervision
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.
-
05 April 2013 /Authorisation and supervision
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.
-
05 April 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 5 April 2013
As of 5 April 2013, new substances have been included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.
-
03 April 2013 /Authorisation and supervision
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.
-
14 March 2013 /Authorisation and supervision
New GDP guidelines from EU
The EU Commission's new guidelines on good distribution practice of medicinal products for human use have now been adopted.
-
11 March 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 6 March 2013
As of 6 March 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.
-
19 February 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 16 February 2013
As of 16 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.
-
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.
-
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.
-
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.
-
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).
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
