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21 December 2012 /Authorisation and supervision
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).
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20 December 2012 /Retail and online sale
Warning against VigRX TM For Men and Viapro
The Danish Veterinary and Food Administration and the Danish Health and Medicines Authority warn against a number of products that are illegal and potentially dangerous to consumers' health. The products include both food supplements and unauthorised medicines.
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20 December 2012 /Authorisation and supervision
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.
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18 December 2012 /About us
Merry Christmas and happy New Year
Thank you for your cooperation and dedication in 2012. We wish you all a merry Christmas and a happy New Year.
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17 December 2012 /About us
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.
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10 December 2012 /Authorisation and supervision
New guideline: renewal of marketing authorisation for nationally authorised medicinal products
The documentation to be submitted with an application to renew a marketing authorisation for nationally authorised medicinal products now follows the rules which apply to the mutual recognition procedure and the decentralised procedure. Likewise, an application for renewal of a marketing authorisation must be made using the EU form.
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07 December 2012 /Authorisation and supervision
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.
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27 November 2012 /Authorisation and supervision
Companies required to check company authorisation on receipt of medicinal products
Pursuant to section 20 of the Danish GDP executive order, companies must ensure, as part of their receipt control activities, that they only receive medicinal products from companies which hold a valid company authorisation or from pharmacies.
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20 November 2012 /Authorisation and supervision
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.
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20 November 2012 /News - medical devices
21 December is final date for submission of clinical investigation applications in 2012
The Danish Health and Medicines Authority is closed between Christmas and New Year. Therefore, applications for authorisation of clinical investigations in 2012 must be received by 21 December 2012. Applications received after this date will be considered received on 2 January 2013.
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16 November 2012 | Updated 16 November 2012 /Side effects and trials
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.
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15 November 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 18 October 2012
In this issue of Danish Pharmacovigilance Update, read about: Risk of developing hepatotoxicity in patients undergoing treatment with agomelatine (Valdoxan®)
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09 November 2012 | Updated 13 November 2012 /Authorisation and supervision
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.
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05 November 2012 /Side effects and trials
European Medicines Agency has started review of codeine-containing medicines
On 3 October 2012, the European Medicines Agency (EMA) started a review of codeine-containing medicines. Codeine-containing medicines are used for pain relief in adults and children. Codeine is to a limited degree converted into morphine in the body. It is well-known that some patients convert codeine to morphine at a faster rate than others, resulting in higher than normal levels of morphine in their blood. This may cause side effects such as breathing difficulties.
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02 November 2012 /Authorisation and supervision
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.
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01 November 2012 /About us
No access to e-forms on Sunday 4 November from 4 to 5 pm
A number of the Danish Health and Medicines Authority’s e-forms cannot be accessed on Sunday 4 November from 4 to 5 pm.
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25 October 2012 | Updated 26 October 2012 /Product areas
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.
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26 October 2012 /Authorisation and supervision
New, higher-strength insulin on the way
The European Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended last week that a new analogue insulin can be marketed in the strengths of 100 units/ml and 200 units/ml. The strength of 100 units/ml has for many years been the only strength available for all insulin products. But from the beginning of 2013, it is expected that the new, higher-strength version will be marketed in Europe, and other insulin products of strengths higher than 100 units/ml are expected to be on the way as well.
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26 October 2012 /News - medical devices
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.
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19 October 2012 /Side effects and trials
The Danish Health and Medicines Authority maintains influenza vaccine recommendation
The European Medicines Agency, EMA, has reviewed a hypothesis on Pandemrix® and the development of sleep attacks (narcolepsy). Overall, EMA assesses that there are no grounds for concerns regarding Pandemrix® and other vaccines, including influenza vaccines.
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19 October 2012 /Side effects and trials
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.
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17 October 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 20 September 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: New definition of adverse reactions due to new European legislation on pharmacovigilance.
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16 October 2012 /News - medical devices
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
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15 October 2012 /Side effects and trials
The Danish Health and Medicines Authority still recommends influenza vaccine
The Danish Health and Medicines Authority still recommends using the Fluarix® seasonal flu vaccine for people who are in a risk group.
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15 October 2012 /Authorisation and supervision
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.
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10 October 2012 /News - miscellaneous
Contaminated medication possibly linked to several meningitis outbreaks in the USA
The health authorities in the USA are presently investigating the cause of a large number of meningitis outbreaks caused by the fungus Aspergillus. In the USA, only those who received the medication in question have been infected, and there have been no reports of transmission from persons to person.
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05 October 2012 /News - miscellaneous
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.
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04 October 2012 /News - miscellaneous
INTERPOL-coordinated operation against illegal internet sale of medicines
Last week, the Danish Health and Medicines Authority took place in a global operation code-named PANGEA V against illegal online trading of medicines together with the Danish tax and customs authorities (SKAT), the Danish Police and the Danish Veterinary and Food Administration. The operation was joined by more than 190 authorities from 100 countries all over the world.
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02 October 2012 /Authorisation and supervision
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.
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28 September 2012 /Side effects and trials
Doctors in Denmark follow new recommendations for contraceptive pills
In early 2012, the Danish Health and Medicines Authority recommended doctors to generally prescribe the older type of contraceptive pills (2nd generation pills) because these pills pose the lowest risk of blood clots. In a follow-up report, the Danish Health and Medicines Authority has now reviewed the latest scientific articles as well as the consumption trends and reported side effects for contraceptive pills prescribed in Denmark.
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24 September 2012 /Authorisation and supervision
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).
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21 September 2012 /Authorisation and supervision
Danish translation of the CMDh's recommendation for the product information of gabapentin
The CMDh has prepared a recommendation for the wording of the product information for gabapentin-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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21 September 2012 /Authorisation and supervision
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.
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21 September 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of risedronate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for risedronate. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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21 September 2012 /Authorisation and supervision
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.
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20 September 2012 /Authorisation and supervision
Time slots for marketing authorisation applications through the decentralised procedure in 2013
From 1 October 2012 to 31 October 2012 (both days included) it will be possible to request time slots for January, February and March 2013 for submission of marketing authorisation applications.
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11 September 2012 /Retail and online sale
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.
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06 September 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 16 August 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Maximum single dose of intravenous ondansetron (Zofran® and others) now restricted to 16 mg.
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03 September 2012 /Authorisation and supervision
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.
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28 August 2012 /Authorisation and supervision
Danish translation of PhVWP's recommendation for the product information - oxcarbazepine (Trileptal)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for oxcarbazepine.
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28 August 2012 /Authorisation and supervision
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.
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22 August 2012 | Updated 27 August 2012 /Product areas
Danish hospitals advised to call in women having received synthetic mesh implants
The Danish Health and Medicines Authority advises Danish hospitals to call in women who have received surgical mesh for pelvic organ prolapse for consultation, examination and evaluation.
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21 August 2012 /Authorisation and supervision
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.
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17 August 2012 /Product information
Do not use Spektramox 50 mg/ml +12.5 mg/ml with batch numbers 96629 and 96630
There is a risk that plastic pieces could be present in Spektramox 50 mg/ml + 12.5 oral solution with batch numbers 96629 and 96630, and consumers in Denmark who, during the past seven days, have received this product should return it to a pharmacy for replacement.
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10 August 2012 /Authorisation and supervision
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.
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03 August 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 21 June 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: Decrease in the number of intoxications and suicide attempts using drugs containing acetylsalicylic acid or paracetamol.
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31 July 2012 /News - miscellaneous
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.
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27 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – July 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 July 2012.
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25 July 2012 /Side effects and trials
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.
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12 July 2012 /Authorisation and supervision
Assessment times for authorisation of medicines for the first six months of 2012
We have published our assessment times for authorisation of medicines for the first six months of 2012.
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10 July 2012 /Product areas
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.
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10 July 2012 /News - medical devices
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.
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05 July 2012 /Authorisation and supervision
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.
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05 July 2012 /Authorisation and supervision
Withdrawal of Certificates of Suitability for the active substances Chlorhexidine digluconate solution and Calcium dobesilate monohydrate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): CEP 2005-076-Rev 01/Chlorhexidine digluconate solution and CEP 2010-209-Rev 00/Calcium dobesilate monohydrate.
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05 July 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – June 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 18-20 June 2012.
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07 June 2012 | Updated 04 July 2012 /About us
New opening hours from 2 July 2012
As part of the merger announced earlier this year, the Danish Health and Medicines Authority introduced new opening hours as of 2 July 2012.
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04 July 2012 /News - miscellaneous
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.
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03 July 2012 /Side effects and trials
New study on treatment with HES (hydroxyethyl starch) in patients with severe sepsis
A new Danish study published in the New England Journal of Medicine has investigated HES used as a plasma substitute in patients with severe sepsis. The study followed 800 patients from intensive care units in Denmark, Iceland, Norway and Finland over a two-year period. The conclusions of the study suggest that HES has a less favourable safety profile than Ringer's acetate used as plasma substitutes in patients with severe sepsis.
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29 May 2012 | Updated 27 June 2012 /Legislation
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.
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25 June 2012 /Legislation
Publication of EU Implementing Regulation on the performance of pharmacovigilance activities
On 20 June 2012, the European Commission's Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council was published in the Official Journal of the European Union.
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22 June 2012 /Authorisation and supervision
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):
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22 June 2012 /Authorisation and supervision
Suspension of Certificate of Suitability for the active substance Povidone iodicated
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2009-166 / Povidone iodicated ...
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22 June 2012 /Authorisation and supervision
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.
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20 June 2012 /Product areas
NHS publishes final report into the safety of PIP implants
An expert group under the National Health Service (NHS) in Britain has published a thorough report on PIP implants. The exhaustive worldwide testing of the PIP gel has not revealed anything that could cause a long-term threat to human health. The implants are not toxic and do not cause cancer. But the risk that the PIP implants may rupture is around two times higher than it is for other brands of implants - around 6-12% after 5 years, and 15-30% after 10 years, whereas the risk associated with other brands is 10-14% after 10 years. The contents of the PIP implants are therefore not harmful, and the gel has not been shown to contain any toxic substances, but the poorer mechanical durability makes the PIP implants a substandard product.
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19 June 2012 /Side effects and trials
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.
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19 June 2012 /News - miscellaneous
Danish Pharmacovigilance Update, 15 March 2012
Among the topics covered in this issue of Danish Pharmacovigilance Update are: A new registry study has investigated the frequency of malformations in newborns after treating the mother with antidepressants (SSRI) during the pregnancy.
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18 June 2012 /Authorisation and supervision
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.
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14 June 2012 /Side effects and trials
Low oestrogen dose in contraceptive pills reduces risk of blood clots
The risk of forming blood clots in brain and heart from the use of contraceptive pills has become smaller as the dose of oestrogen contained in contraceptive pills has been lowered. Moreover, blood clots in brain and heart are generally less frequent than blood clots in legs and lungs, so shows a new Danish study on a cohort of 1.6 million Danish women aged between 15 and 49.
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08 June 2012 | Updated 13 June 2012 /Authorisation and supervision
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
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17 April 2012 | Updated 12 June 2012 /Authorisation and supervision
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08 June 2012 /About us
Reception for Jytte Lyngvig
At the end of June, Director Jytte Lyngvig will be retiring from her position at the Danish Health and Medicines Authority. We invite you to a reception in her honour on Thursday 28 June 2012 from 14:00 to 16:00 at the Danish Health and Medicines Authority.
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08 June 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of SSRIs
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for SSRIs (fluvoxamine, citalopram, escitalopram, fluoxetine, sertraline and paroxetine). The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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07 June 2012 /Side effects and trials
Report on clinical trials of medicines in humans notified in 2011
The Danish Health and Medicines Authority has published an annual report on applications for clinical trials of medicines in humans.
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07 June 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of paracetamol solution for infusion
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for paracetamol solution for infusion and the risk of accidental overdosing of neonates, infants and underweight adults (due to medication errors following confusion between mg and ml).
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06 June 2012 /Authorisation and supervision
Amendment of executive order on euphoriant substances
On 2 June 2012, 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 and Prevention. The following substances are included in schedule B.
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31 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – May 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 21-23 May 2012.
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29 May 2012 /Side effects and trials
Risk of blood clots associated with hormonal contraceptives
A new major Danish registry study has investigated the risk of blood clots in women using different types of hormonal contraceptives. The study concludes, among other things, that women using a vaginal ring (Nuvaring®) or contraceptive patch (Evra®) have the highest risk of blood clots.
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24 May 2012 /Side effects and trials
European Commission publishes guideline concerning the quality of biological investigational medicinal products in clinical trials
The European Commission has published a guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials.
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23 May 2012 /Side effects and trials
Increased risk of cardiac arrest associated with the use of TCA and SSRI antidepressants
A new Danish study has found an increased risk of cardiac arrest associated with treatment with TCAs (tricyclic antidepressants) or SSRIs (selective serotonin reuptake inhibitors). The study found no association between increased risk of cardiac arrest and the use of SNRI antidepressants (serotonin and norepinephrine reuptake inhibitors) or NaSSA antidepressants (noradrenergic and specific serotonergic antidepressants).
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15 May 2012 /Side effects and trials
Pradaxa – consider age and follow dose recommendations
In March, in collaboration with the Thrombosis Centre in Aalborg, the Danish Health and Medicines Authority published an evaluation of all adverse reaction reports in Danish Pharmacovigilance Update for the period 22 August 2011 up to and including 23 February 2012 in connection with a new indication (prevention of apoplexy in patients with non-valvular atrial fibrillation) for Pradaxa® (dabigatran etexilate). With this announcement, we once more want to call attention to the development in consumption, reported adverse reactions, age and dose recommendations.
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14 May 2012 /Authorisation and supervision
Announcement of time slots for decentralised procedures in 2013
The Danish Health and Medicines Authority announces allocation periods for time slots in 2013 for decentralised procedures (DCP) with Denmark as Reference Member State (RMS).
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10 May 2012 /Side effects and trials
Drug Analysis Prints with data from more than 14,000 side effect reports
In February, the Danish Health and Medicines Authority published the first 14 of approximately 1,000 adverse reactions prints, called Drug Analysis Prints, of suspected adverse drug reactions (ADRs) reported by doctors, patients and relatives. We have now published the rest.
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01 May 2012 /Side effects and trials
Questions and answers from the Clinical Trial Facilitation Group on trial designs and DSUR
The Clinical Trial Facilitation Group (CTFG) has drawn up a Q&A document on specific trial designs and a document on Development Safety Update Report (DSUR). The CTFG was formed in 2004 by the Heads of Medicines Agencies (HMA), one of the purposes being to obtain a more uniform interpretation of the EU regulatory requirements.
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01 May 2012 /Authorisation and supervision
Clarification regarding parallel imported medicines when the directly imported medicinal product has been deregistered
Generally, it is the parallel importer's responsibility to maintain the authorised summary of product characteristics (SPC) and the package leaflet (PL) when the directly imported medicinal product has been deregistered. Therefore any changes to the SPC and PL, including regular updates to the safety information, must be submitted as variation applications by the parallel importer.
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – April 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 16-18 April 2012. Among the topics discussed at the meeting were:
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01 May 2012 /Side effects and trials
Monthly report from the EU Pharmacovigilance Working Party, PhVWP – March 2012
The EU Pharmacovigilance Working Party (PhVWP) convened on 12-14 March 2012. Among the topics discussed at the meeting were:
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30 April 2012 /Authorisation and supervision
Submission of package leaflets and product labelling in connection with parallel import
The Danish Health and Medicines Authority reminds companies submitting parallel import applications to enclose the package leaflet and labelling on an A4 sheet in a readable font size. The font size used must be size 11 or more.
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25 April 2012 /Retail and online sale
MaxiMenPills – an illegal potency-enhancing product
An analysis performed by the Danish Health and Medicines Authority of the potency-enhancing product MaxiMenPills, previously marketed by a Danish online shop, has established that the product contains two active substances, which are not declared on the package.
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25 April 2012 /Side effects and trials
Use of EU register facilitates publication of clinical research
Researchers who author articles based on clinical trial results can now avoid having to publish the same study in two different public registers. They can avoid double-registration because the EU Clinical Trials Register has now been recognised by the World Health Organization (WHO’s International Clinical Trials Registry Platform) as a so-called 'primary registry' like its US counterpart ClinicalTrials.gov.
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24 April 2012 /Authorisation and supervision
The EDQM has withdrawn the Certificate of Suitability for the active substance Acetylsalicylic acid
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2006-195-Rev 00 / Acetylsalicylic acid.
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24 April 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance Stanozolol Micronised
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificate of Suitability (CEP): R1-CEP 2002-222-Rev 01 / Stanozolol Micronised.
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24 April 2012 /Authorisation and supervision
The EDQM has withdrawn the Certificate of Suitability for the active substance Oxaliplatin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificate of Suitability (CEP): R0-CEP 2005-158-Rev 00 / Oxaliplatin.
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23 April 2012 /Side effects and trials
Gilenya (fingolimod) – new recommendations to reduce risk of adverse effects on the heart
The European Medicines Agency has recommended new advice to healthcare professionals to reduce the risk of adverse effects on the heart associated with the use of the multiple sclerosis treatment Gilenya (fingolimod).
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18 April 2012 /Authorisation and supervision
The EDQM has withdrawn Certificates of Suitability for the active substance Diclofenac Sodium
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn the following Certificates of Suitability (CEP): R0-CEP 2006-304-Rev 00 Diclofenac Sodium and R1-CEP 2000-133-Rev 02 Diclofenac Sodium.
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17 April 2012 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information – proton-pump inhibitors' class effects on magnesium blood levels from long-term use
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information concerning the class effects of proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole) on magnesium blood levels from long-term use.
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17 April 2012 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information – prescription-only proton-pump inhibitors and risk of fractures of the hip, wrist and spine
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for prescription-only proton-pump inhibitors (omeprazole esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine.
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17 April 2012 /Authorisation and supervision
The EDQM has withdrawn Certificates of Suitability from CSPC Innovation Pharmaceutical Co., Ltd.
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has withdrawn a number of Certificates of Suitability (CEP) from CSPC Innovation Pharmaceutical Co., Ltd.
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13 April 2012 /Side effects and trials
Risk-adapted assessment of clinical trials of already marketed medicinal products
The Danish Health and Medicines Authority has looked into the possibility of assessing clinical trials of already marketed medicinal products based on risk adaptation. We now offer shorter assessment times for clinical trials where the risk involved for patients is not higher than the risk of exposing the trial participant to standard treatment.
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11 April 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of topiramate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for topiramate-containing medicines. The Danish Health and Medicines Authority has now translated this recommendation into Danish.
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11 April 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance Trimetazidine dihydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): RO-CEP 2007-245-Rev 01 Trimetazidine dihydrochloride.
