News about licensing of medicines

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.

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.

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.

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.

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.

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.

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.

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.

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.

Danish translation of the PhVWP's revised recommendation for the product information of fluoroquinolones

The European Pharmacovigilance Working Party, PhVWP, has prepared a revised recommendation for the wording of the product information for fluoroquinolones. The Danish Health and Medicines Authority has now translated this recommendation into Danish.

Danish translation of the PhVWP's recommendation for the product information of SSRIs

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for SSRIs (fluvoxamine, citalopram, escitalopram, fluoxetine, sertraline and paroxetine). The Danish Health and Medicines Authority has now translated this recommendation into Danish.

Announcement of time slots for decentralised procedures in 2013

The Danish Health and Medicines Authority announces allocation periods for time slots in 2013 for decentralised procedures (DCP) with Denmark as Reference Member State (RMS).

Submission of package leaflets and product labelling in connection with parallel import

The Danish Health and Medicines Authority reminds companies submitting parallel import applications to enclose the package leaflet and labelling on an A4 sheet in a readable font size. The font size used must be size 11 or more.

Translation of the PhVWP's recommendation for product information – prescription-only proton-pump inhibitors and risk of fractures of the hip, wrist and spine

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for prescription-only proton-pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine.

Danish translation of the PhVWP's recommendation for product information – antiepileptics and possible risk of bone disorder

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine and sodium valproate. The Danish National Board of Health has now translated this recommendation into Danish:

Danish translation of the PhVWP's recommendation for the product information ketoprofen and ketorolac

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for ketoprofen and ketorolac. The Danish Medicines Agency has now translated this recommendation into Danish.

Danish translation of the PhVWP's recommendation for the product information of gonadotropin-releasing hormone agonists

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for gonadotropin-releasing hormone agonists (buserelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin). The Danish Medicines Agency has now translated this recommendation into Danish.

Danish translation of the PhVWP's recommendation for the product information of HMG-CoA reductase inhibitors (statins)

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for HMG-CoA reductase inhibitors. The Danish Medicines Agency has now translated this recommendation into Danish.

Danish translation of the PhVWP's recommendation for the product information of tibolone (Livial)

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for tibolone-containing medicines. The Danish Medicines Agency has now translated this recommendation into Danish.

Danish translation of the PhVWP's recommendation for the product information of Strattera (atomoxetine)

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for Strattera (atomoxetine). The Danish Medicines Agency has now translated this recommendation into Danish.

Danish Medicines Agency resumes allocation of DCP time slots for the period July-October 2012

From 16 January until 6 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.

Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.

Available time slots for DCP procedures with Denmark as Reference Member State (RMS)

The Danish Medicines Agency announces that some DCP procedure time slots have become available in November and December 2011.

Assessment times for authorisation of medicines for the first six months of 2011

We have just published our assessment times for authorisation of medicines for the first six months of 2011.

New guidelines on submittable formats for applications for marketing authorisation, variations, etc.

The Danish Medicines Agency has formulated new guidelines on submittable formats for applications for marketing authorisation, variations, update prior to MRP, renewal, follow-up and referral to CMD. In addition, the guidelines on submission of paper applications have been revised. The new guidelines are intended to make it easier for companies to submit applications electronically and to ease our electronic processing of applications.

Licensing of medicines prioritisation and forecast processing times for the second half of 2011

Every six months, we prioritise and forecast processing times for the authorisation of medicines. Our forecast for the second half of 2011 and status on the first half of 2011 are now ready.

Generic substitution terminated for oral medicines containing cyclosporine or tacrolimus

With regard to generic medicines for oral use that contain cyclosporine or tacrolimus, it has so far been possible to label these as generically substitutable if the medicines were assessed to be therapeutically interchangeable. Provided, however, that bioequivalence between the generic version and the original product is established based on stringent criteria. Following a reassessment, the Danish Medicines Agency now considers that generic substitution should no longer be possible for these to active substances.

Antidepressants for treatment of children and adolescents

In continuation of a report on Danish television in ‘DR 21’ on Sunday 1 May 2011 on the risk of suicide from using SSRIs to treat children and adolescents, the Danish Medicines Agency has the following comments.

Requests for DCP time slots for the first half of 2012 now possible

Until 30 April 2011 , the Danish Medicines Agency is open for requests for DCP time slots for the first half of 2012.

Information on extended deadline for implementation of updates to labelling and package leaflets for variations

In October-November 2010, the Danish Medicines Agency opened a consultation on a proposal to extend the deadline for implementation of updates to labelling and package leaflets for variations. We now publish a consultation note (in Danish only) and describe the next steps in implementing the extended deadline for implementation.

Licensing of medicines – prioritisation and forecast processing times for the second half of 2010

We still find it important to maintain a high level of participation as rapporteur/co-rapporteur in applications under the centralised procedure as well as a high level of engagement in providing scientific advice to the EMA.

The Danish Medicines Agency resumes the allocation of time slots for the second half of 2011

From 3 May 2010 to 31 May 2010 (both days included) the Danish Medicines Agency resumes the allocation of time slots for the second half of 2011.

Information about variation applications from 1 January 2010

In a new regulation, the European Commission has established new rules that regulate variations of authorisations granted according to the Centralised Procedure, Decentralised Procedure (DCP) and the Mutual Recognition Procedure (MRP).

Updated template for headlines and standard texts in summaries of product characteristics and package leaflets for the centralised procedure