News items 2015
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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.