News

The benefits of acne treatment (Diane® Mite, etc.) still outweigh risks in specific patients

The European Medicines Agency's Pharmacovigilance Risk Assessment Committee (PRAC) has investigated the safety of medicines containing cyproterone acetate and ethinylestradiol, which are used in the treatment of acne (Diane® Mite, etc.). The Committee concludes that the benefits of this type of medicine outweigh the risks, provided it is used in specific patients and measures are taken to minimise the risk of blood clots.

New version of the guidance document Voluntary Harmonisation Procedure for clinical trials

April saw the release of version 3 of the Voluntary Harmonisation Procedure (VHP), a voluntary procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries.

New European list of medicines under additional monitoring

The European Medicines Agency (EMA) has published a list of medicines that are subject to additional monitoring. From the autumn of 2013, these medicines will display an inverted black triangle in their package leaflet and the summary of product characteristics with information for patients and healthcare professionals.

Nyt Om Bivirkninger 25 april 2013

Danish Pharmacovigilance Update, 21 February 2013

In this issue of Danish Pharmacovigilance Update: Cardiovascular monitoring when initiating and re-initiating treatment with fingolimod (Gilenya®).

Updating of summary of product characteristics prompted by changed ATC codes for 2013

We advise marketing authorisation holders of veterinary medicinal products authorised under the decentralised procedure and the mutual recognition procedure that some ATC codes have changed in 2013.

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.

Preliminary data on Medicine Prices available to all subscribers of Medicine Prices for Companies

As of 1 March 2013, anyone who subscribes to Medicine Prices for companies has access to preliminary data on Medicine Prices. Preliminary data will be made available 11 and 10 days prior to the effective date of a new medicine price period. This follows from an amendment to the Danish executive order no. 59 of 29 January 2009 on medicine prices and supply conditions.

Amendment of Danish executive order on euphoriant substances 6 March 2013

As of 6 March 2013, the substances below are included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.

Direct Healthcare Professional Communication is published on the website

The Danish Health and Medicines Authority will in future place the Direct Healthcare Professional Communications (DHPCs) that are sent out in Denmark to doctors and others here on the website.

Doctors in Denmark follow the recommendations for contraceptive pills

The French authorities recently asked the Pharmacovigilance Risk Assessment Committee (PRAC) to review the safety of the newer types of contraceptive pills (3rd and 4th generations). This follows the last couple of years' several investigations which have indicated that these pills carry a small increased risk of blood clots compared to the older versions (2nd generation). In Denmark, we have already taken steps to counter this increased risk

Apply online for licensing of medicines via CESP

The pharmaceutical industry can now use a new online platform called CESP (Common European Submission Platform) to submit applications and material related to the licensing of medicines to the Danish Health and Medicines Authority. CESP reduces the administrative burdens of submitting and handling applications on CD/DVD for both the Danish Health and Medicines Authority and the industry, which is why we encourage applicants to switch to CESP submission.

Danish Pharmacovigilance Update, 20 December 2012

In this issue of Danish Pharmacovigilance Update: The Danish Health and Medicines Authority encourages doctors to be aware of suspected long-term adverse reactions from the use of SSRIs in children and adolescents.

Updating of summary of product characteristics prompted by changed ATC codes for 2013

We advise marketing authorisation holders of medicinal products authorised under the Decentralised Procedure and the Mutual Recognition Procedure that some ATC codes have changed in 2013.

Changes affecting company authorisations and new registrations of companies

The implementation of directive 2011/62/EU of 8 June 2011 on falsified medicines implies changes to company authorisations. At the same time, the concept of wholesale distribution becomes broader and will in future cover distribution (purchase and sale) of medicinal products whereas before the physical handling of medicinal products was the pivotal element in the granting of wholesale dealer's authorisations (GDP).

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.

New EAN number and CVR number from 1 January 2013

From 1 January 2013, the Danish Health and Medicines Authority will have a common CVR number and EAN number, which replace the previous numbers of the former National Board of Health and the Danish Medicines Agency.

Annual report on human tissues and cells 2011

The annual report for human tissues and cells for 2011 has been prepared pursuant to the Danish Tissue Act and is based on reports submitted by tissue establishments and gynaecology clinics in Denmark in the period January to December 2011.

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.

21 December is final date for submission of clinical trial applications in 2012

The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical trials in 2012 must reach us by 21 December 2012. All applications that we receive after this date will be considered received on 2 January 2013.

Withdrawal of older medicines in Denmark

A current debate in the Danish media has focused on the withdrawal of a number of older medicines, and we here give a status on the medicines concerned. In 2002, the former Danish Medicines Agency was approached by the Association of Danish Pharmacies concerning 23 named medicines which were all authorised long before the introduction of the first Danish Medicines Act in 1976, mainly in the 1950s.

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.

Criticism of CE marking of medical devices in Czech Republic and Slovakia

The Danish Health and Medicines Authority has asked the European Commission to take action in a case concerning whether two named notified bodies in the Czech Republic and Slovakia comply with EU medical devices law.

Criticism of CE marking of medical devices in Czech Republic and Slovakia

In cooperation with the British Medical Journal, the Daily Telegraph reported today that two named notified bodies in the Czech Republic and Slovakia do not comply with EU medical devices law. It appears from the articles that companies can have their medical devices certified by the notified bodies based on a hasty and superficial evaluation. It is also claimed that companies can have products certified that resemble products which have been removed from the market because of safety problems.

Benefits of NSAIDs still outweigh risks - but diclofenac may be associated with a small increased risk of side effects

In October 2011, the Committee for Medicinal Products for Human Use (CHMP) decided to review the newest data on cardiovascular side effects from analgesics (painkillers) of the NSAID type. The conclusions are now available, and they confirm the previous conclusions from 2005 and 2006 that the benefits of NSAIDs still outweigh the risks.

European Commission proposes two new regulations on medical devices and in vitro diagnostic devices

The European Commission has proposed two new regulations on medical devices and in vitro diagnostic devices. This launches the European Union's (EU) legislative decision-making process

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.

Warning against illegal potency enhancers

The Danish Health and Medicines Authority warns against widespread sale of illegal potency enhancers. Over the first nine months of 2012, the Danish Health and Medicines Authority was made aware of 54 illegal potency-enhancing products found to contain active pharmaceutical ingredients not declared anywhere on the package or in the product information. The findings are a result of international cooperation.

Amendment of executive order on euphoriant substances of 30 September 2012

On 30 September 2012, a new substance was included in annex 1 of the executive order no. 557 of 31 May 2011 on euphoriant substances.

Important notice to marketing authorisation holders/representatives of medicines containing cephalosporins

Four Chinese companies have been found to have used waste gutter oil in the manufacturing of 7-aminocephalosporanic acid (7-ACA).

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.

Repeated warning against the scam company Helse Danmark

Many Danes use glucosamine for joint pain, but thousands are tricked into buying glucosamine illegally from Helse Danmark, which operates the website sundeled.dk and other websites. Consumers who buy illegal medicines risk getting a fine of DKK 2,500. In this specific case, several Danes report that they have also been threatened with debt collection when they tried to return the illegal medicine to Helse Danmark.

Company authorisations issued without expiry date

As of 1 September 2012, the Danish Health and Medicines Authority implements a new practice by which company authorisations are no longer issued with an expiry date. The company authorisations issued in future will therefore only bear an effective date, implying that the authorisation is valid until it is changed or terminated.

Danish translation of the PhVWP's recommendation for the product information - carbamazepine

The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine.

Tests of glycerol used in magistral formulations and marketed medicinal products

Supplementing the enhanced control of active substances (the API project), the Danish Health and Medicines Authority has recently put increased focus on further testing of excipients. The Danish Health and Medicines Authority's laboratory has analysed the excipients glycerol and glycerol 85%. Samples of the excipient have been submitted by pharmacies that perform magistral formulations and by companies with marketed medicinal products. Analyses have been performed on glycerol batches from seven pharmacies and five companies.

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 Pharmacovigilance Update, 24 May 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Drug Analysis Prints involving data from more than 14,000 Danish adverse reaction reports available at the Danish Health and Medicines Authority’s website.

Sun, heat and medicine

Various medicines can make your skin more sensitive to sunlight (photosensitivity), and it concerns both medicines in tablet form and other forms, such as creams. You should therefore protect yourself from the sun by wearing clothes, a hat or by using a good sunscreen if you take medicine that makes your skin more sensitive to light.

Surgery with the da Vinci Surgical System resumed in Denmark

Robotic surgery using the da Vinci Surgical System will resume Tuesday 10 July in Denmark, after having been halted for the past two weeks. The decision to resume surgery with the da Vinci Surgical System was taken by the five national robot centres based on an independent investigation and further documentation from the manufacturer Intuitive Surgical.

Suspension of Certificate of Suitability for the active substance Leflunomide

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): CEP 2009-035/Leflunomide.

Monthly report from the EU Pharmacovigilance Working Party, PhVWP – June 2012

The EU Pharmacovigilance Working Party (PhVWP) convened on 18-20 June 2012.

Danish Pharmacovigilance Update, 19 April 2012

Among the topics covered in this issue of Danish Pharmacovigilance Update are: Split and crushed tablets containing finasteride may pose a risk for pregnant and fertile women.

New European legislation improves the monitoring of adverse reactions and strengthens patient safety

In July 2012, new pharmacovigilance legislation comes into effect across the EU. The purpose of the new legislation is to strengthen patient safety by improving the present system used for monitoring safety of medicines in Europe.

Suspension of Certificates of Suitability for several active substances from the manufacturer Amoli Organics PVT Ltd

EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended a number of Certificates of Suitability (CEP):

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.

European Medicines Agency assesses risk of the arthritis medicine diclofenac

In response to recent days' debate about the safety of the arthritis medicine diclofenac, the Danish Health and Medicines Authority urges doctors to carefully follow the restrictions and precautions for use that are already described in the medicine's summary of product characteristics and on the Danish website medicin.dk.

Assessment times for authorisation of medicines for the first three months of 2012

We have published our assessment times for authorisation of medicines for the first three months of 2012.

Certificates of Suitability for the active substances Oxytetracycline dihydrate and Oxytetracycline hydrochloride have been withdrawn

Updated: The following Certificates of Suitability (CEPs) have been withdrawn at the request of the manufacturer. CEP 2004-177-Rev 00/ Oxytetracycline dihydrate CEP 2008-165-Rev 00/ Oxytetracycline hydrochloride