News items 2014
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Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - December 2014
| 10 December 2014 |
PRAC held its last meeting for this year on 1-4 December 2014. During its December meeting, the PRAC did not initiate or conclude any safety referral. The Committee focused on the broad spectrum of its responsibilities, which cover all aspects of the risk management of the use of medicines.
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New procedure for follow up on adverse drugs reaction reports as of 15 December 2014
| 10 December 2014 |
The Danish Health and Medicines Authority are by 15 December 2014 implementing a new targeted procedure for collecting additional information to reports on adverse drug reactions.
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Available time slots in Q1 2015 for DCP applications with Denmark as reference member state
| 14 November 2014 |
Companies wishing to apply for a marketing authorisation for a medicinal product can request a specified submission date (time slot). Time slots are available in the first quarter of 2015.
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Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - November 2014
| 14 November 2014 |
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 3-6 November 2014.
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Updated guidelines on activities subject to a section 39 authorisation
| 21 October 2014 |
We have updated our guidelines on activities subject to a section 39 authorisation or a company registration.
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PRAC recommends strengthening the restrictions on the use of valproate in women and girls
| 17 October 2014 |
The EMA’s Pharmacovigilance and Risk Assessment Committee (PRAC) recommends strengthening the restrictions on the use of the antiepileptic valproate due to the risk of malformations and developmental problems in children exposed to valproate in the womb.
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Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - October 2014
| 14 October 2014 |
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 6-9 October 2014.
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Consultation procedure about medicinal products and safety measure requirements not completed yet
| 03 October 2014 |
On 5 September 2014, the Danish Health and Medicines Authority submitted a draft list of the medicinal products comprised by the new safety measures rules (Directive 2001/83) for consultation. The consultation period expired on 17 September 2014, and on 3 October we were to inform the European Commission of the medicinal products we recommend including in the common EU lists. We have received 22 consultation responses. But on 24 September 2014 the European Commission amended the original guideline for how to interpret the criteria used to assess whether a medicinal product is qualified for the white list.
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New rules for persons collaborating with the industry
| 07 October 2014 |
As of 1 November 2014, new rules governing healthcare professionals' collaboration with pharmaceutical and medical companies take effect. The rules governing association will be extended to include medical companies and nurses. Doctors' association with speciality stores trading in medical devices are also covered by the rules.
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Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - September 2014
| 23 September 2014 |
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 8-11 September 2014.
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Consultation: rules of procedure for public hearings in the EMA
| 29 August 2014 |
The European Medicines Agency (EMA) has launched a public consultation on draft rules of procedures for public hearings held by its Pharmacovigilance Risk Assessment Committee (PRAC).
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Italian case about stolen medicine affects Denmark
| 29 August 2014 |
21 stolen packages of medicine from Italy have probably been sold on the Danish and German markets. The Danish Health and Medicines Authority has asked the company to recall the medicine (the batch).
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Good laboratory practice in non-clinical trials
| 29 July 2014 |
Clinical Trials Facilitation Group (CTFG) has prepared a document describing the requirements as to good laboratory practice (GLP) in non-clinical trials.
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Monthly report from the EU Pharmacovigilance Risk Assessment Committee (PRAC) - July 2014
| 15 July 2014 |
The EU Pharmacovigilance Risk Assessment Committee (PRAC) convened on 7-10 July 2014.
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Monitoring of medicines for births
| 07 July 2014 |
The Danish Health and Medicines Authority has prepared a midterm review of the activities in the action plan for Danish regions' use of medicines for the induction of labour. The action plan was launched in the autumn of 2013 following a public debate about the use of these medicines, and it should be completed by the end of 2015.
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More clinical trials to Denmark
| 03 July 2014 |
The number of clinical trial applications increased by 35 trials (14%) from 2012 to 2013, which is the highest level in seven years. The increase covers both companies and researchers according to the Danish Health and Medicines Authority's annual report 2013 on clinical trials of medicines in humans.
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Changed procedure for information on duplicate closed and nullified closed cases (updated)
| 15 July 2014 |
The new process for dispatching adverse reaction reports (ASPR) will be implemented on 12 and 13 July 2014.
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Focus on correct dose of Pro-Epanutin
| 24 June 2014 |
The Danish Health and Medicines Authority encourages hospitals to pay special attention to the risk of dose errors of the anticonvulsant medicine Pro-Epanutin.
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Amendment of executive order on euphoriant substances 30 May 2014
| 03 June 2014 |
On 30 May 2014, the substances below were 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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Regulation on clinical trials on medicinal products adopted
| 03 June 2014 |
The European Commission's proposal for new European legislation on clinical trials of medicinal products was adopted in early 2014. The objective is to promote the number of clinical trials in the EU.