Danish Pharmacovigilance Update, 26 September 2013
In this issue of Danish Pharmacovigilance Update: News from the EU Filgrastim (Neupogen) and pegfilgrastim (Neulasta) are associated with risk of capillary leak syndrome Use of bromocriptine...
View ArticleDigital post from the Danish Health and Medicines Authority
From 1 November 2013, it is mandatory for businesses with a CVR number to be able to receive digital post from public authorities. What is digital post? e-Boks has developed an electronic mailbox...
View ArticleDeadline for applications for marketing authorisation of medicinal products
The Danish Health and Medicines Authority is closed over Christmas and New Year. Therefore, the deadline for submission of applications in 2013 is Friday 20 December. All applications that we receive...
View ArticleDecreasing prevalence of illicit drugs
The prevalence of illicit drugs is decreasing according to this year's report on the drug situation in Denmark 2013 prepared by the Danish Health and Medicines Authority. New figures show that...
View ArticleEU harmonisation of Qualified Person's Declarations for clinical trials
The European Commission has published a template for the Qualified Person’s Declaration Concerning GMP (Good Manufacturing Procedure) Compliance of the Investigational Medicinal Products. The aim of...
View ArticleDr Christian Schneider new Medical Head of Division
Medicines Licensing & Availability has employed Dr Christian Schneider as new Medical Head of Division. Christian Schneider will take up his new position on 15 December 2013. The division was...
View ArticleECA 30+, an illegal weight-loss product, may give serious side effects
The Danish Health and Medicines Authority has received a serious adverse reaction report about the illegal weight-loss product ECA 30+ bought on the internet. ECA 30+ is said to speed up metabolism...
View ArticleMedical use of cannabis
The Danish Health and Medicines Authority has prepared a memo about the Danish experiences with and rules applicable to medical use of cannabis. Medicines containing cannabis must be prescribed by a...
View ArticleThe DHMA over Christmas and New Year
The Danish Health and Medicines Authority is closed over Christmas and New Year. But please see the special opening hours for compassionate use permits, the National Institute of Radiation Protection...
View ArticleAnnual update for registered API companies
Companies manufacturing, importing and/or distributing active substances (API) intended for use in the manufacturing of medicinal products for human use and covered by a marketing authorisation must...
View ArticleUpdating of summaries of product characteristics due to changed ATC codes...
Marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure should be aware that some ATC codes have been changed in 2014....
View ArticleRevocation of wholesale distribution and manufacturing authorisations...
On 20 December 2013 and on 10 January 2014, the Danish Health and Medicines Authority decided to revoke the section 39 authorisations for wholesale distribution and manufacturing of medicinal products...
View ArticleReimbursement of medicines bought in another EU/EEA country
From 1 January 2014, you can obtain reimbursement of prescription-only medicines bought in another EU/EEA country under the general reimbursement rules of the Danish Health Act. You have to be covered...
View ArticleQuestions and answers to new good distribution practice guidelines
The guidelines on good distribution practice of medicinal products for human use came into force on 7 September 2013. These guidelines are an update of the previous guidelines in this area. You can...
View ArticleTime slots for DCP procedures with Denmark as Reference Member State (RMS)
The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised...
View ArticleRecommendations for organ donation
More people should decide whether they wish to become a potential organ donor and the hospitals should introduce pathways. These are two of the recommendations of a working group headed by the Danish...
View ArticleInformation to MAHs for new combined hormonal contraceptives
After the most recent EU review of a number of new combined contraceptives under Article 31 of Directive 2001/83/EC, it was decided that marketing authorisation holder (MAHs) for these products must...
View ArticleGuidelines on applications for authorisation to wholesale distribute...
The Danish Health and Medicines Authority has updated the Guidelines on applications for authorisation to wholesale distribute medicines within the EU/EEA. The guidelines now include guidance to...
View ArticleDanish Pharmacovigilance Update 19 December 2013
In this issue of Danish Pharmacovigilance Update: News from the EU Restrictions on the use of metoclopramide (Primperan® etc.) for the treatment of nausea and vomiting Letters of safety information...
View ArticleEMA recommends further restrictions on the use of the osteoporosis medicine...
The European Medicines Agency (EMA) recommends to restrict the use of the osteoporosis medicine strontium ranelate (Protelos®) to patients with severe osteoporosis who cannot be treated with other...
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