News items 2015
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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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Danish Pharmacovigilance Update, November 2014
| 02 December 2014 |
Five years ago, we issued Danish Pharmacovigilance Update for the first time. We are delighted to celebrate the newsletter's fifth anniversary with more than 3,000 subscribers to the Danish and the English version, and we hope the interest in Danish Pharmacovigilance Update will continue to grow. You can sign up for the newsletter on our website under News. Among the articles in this issue, you can read about how we have developed the pharmacovigilance activities in the recent years.
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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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Danish Pharmacovigilance Update, October 2014
| 11 November 2014 |
Read the October issue of Danish Pharmacovigilance Update.
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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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Danish Pharmacovigilance Update, September 2014
| 07 October 2014 |
The September issue of Danish Pharmacovigilance Update.
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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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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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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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Danish Pharmacovigilance Update, August 2014
| 09 September 2014 |
The August issue of Danish Pharmacovigilance Update.
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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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Danish Pharmacovigilance Update June 2014
| 17 July 2014 |
The June issue of Danish Pharmacovigilance Update.
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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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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.