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03 May 2013 /Authorisation and supervision
Application for parallel import from Croatia
On 1 July 2013, Croatia joins the EU after which it will be possible to apply for parallel import with Croatia as import country.
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05 April 2013 /Authorisation and supervision
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.
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05 April 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 5 April 2013
As of 5 April 2013, new substances have been included in annex 1 of executive order no. 557 of 31 May 2011 on euphoriant substances issued by the Danish Ministry of Health.
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03 April 2013 /Authorisation and supervision
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.
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14 March 2013 /Authorisation and supervision
New GDP guidelines from EU
The EU Commission's new guidelines on good distribution practice of medicinal products for human use have now been adopted.
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11 March 2013 /Authorisation and supervision
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.
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19 February 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 16 February 2013
As of 16 February 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.
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01 February 2013 /Authorisation and supervision
Amendment of Danish executive order on euphoriant substances 1 February 2013
As of 1 February 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.
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30 January 2013 /Authorisation and supervision
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.
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23 January 2013 /Authorisation and supervision
Register as a broker of medicinal products or as a manufacturer, distributor or importer of active substances in Denmark
The new directive on falsified medicinal products was implemented into Danish law on 1 January 2013 after a consultation process. Under the new rules, companies which broker medicinal products and companies which manufacture, import or distribute active substances in Denmark must register their activities with the Danish Health and Medicines Authority.
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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 /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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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 /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 /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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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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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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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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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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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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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.
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28 March 2012 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances Pilocarpine nitrate and Pilocarpine hydrochloride
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEPs): CEP 1997-034-Rev 02 / Pilocarpine hydrochloride and CEP 2002-202-Rev 00 / Pilocarpine nitrate.
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22 March 2012 /Authorisation and supervision
Danish package leaflet database checked for statutory uploads
Companies that sell medicines on the Danish market are obliged to make the newest package leaflet available at the Danish package leaflet website indlaegsseddel.dk. To ensure compliance with the rules, the former Danish Medicines Agency (now the Danish National Board of Health) has checked if all medicines sold in Denmark have a corresponding package leaflet on the website indlaegsseddel.dk. There are about 5,300 different medicines on the Danish market, and all of them have been checked. About 8 % had deficiencies in relation to the statutory requirements.
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15 March 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for product information – antiepileptics and possible risk of bone disorder
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for carbamazepine, phenobarbital, phenytoin, primidone, oxcarbazepine, lamotrigine and sodium valproate. The Danish National Board of Health has now translated this recommendation into Danish:
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15 March 2012 /Authorisation and supervision
Revised Danish translation of the PhVWP's recommendation for the product information of rosuvastatin (Crestor)
The European Pharmacovigilance Working Party, PhVWP, has revised its recommendation for the wording of the product information for rosuvastatin. The undesirable effect “gynecomastia” has been revised to only involve men.
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01 March 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information ketoprofen and ketorolac
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for ketoprofen and ketorolac. The Danish Medicines Agency has now translated this recommendation into Danish.
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29 February 2012 /Authorisation and supervision
Compliance check of package leaflets and product labelling (winter 2012)
Companies marketing medicines in Denmark are responsible for ensuring that their package leaflets and labelling comply with the Danish executive order on labelling. The Danish Medicines Agency regularly carries out random compliance checks of package leaflets and product labelling.
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23 February 2012 /Authorisation and supervision
The EDQM has suspended the Certificates of Suitability for the active substances theophylline, theophylline-ethylenediamine anhydrous and caffeine
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificates of Suitability (CEP) for a number of active substances.
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22 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of escitalopram
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for escitalopram-containing medicines.The Danish Medicines Agency has now translated this recommendation into Danish.
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21 February 2012 /Authorisation and supervision
Romanian wholesale dealer has used forged authorisation
The Romanian authorities warn against a company which has used a forged wholesale dealer's authorisation to trade with other European companies. The company concerned is:INTER PHARMA GOLD SRL.
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17 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of gonadotropin-releasing hormone agonists
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for gonadotropin-releasing hormone agonists (buserelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin). The Danish Medicines Agency has now translated this recommendation into Danish.
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17 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of methotrexate
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for methotrexate. The text is used to prepare new product information for medicines with methotrexate.
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17 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of HMG-CoA reductase inhibitors (statins)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for HMG-CoA reductase inhibitors. The Danish Medicines Agency has now translated this recommendation into Danish.
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15 February 2012 /Authorisation and supervision
DCP time slots for the period July-October 2012 still available
From 13 February until 27 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.
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08 February 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of tibolone (Livial)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for tibolone-containing medicines. The Danish Medicines Agency has now translated this recommendation into Danish.
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07 February 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 Certificate of Suitability (CEP): CEP R0-2007-254-Rev01 trimetazidine dihydrochloride.
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07 February 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance erythromycin
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for the active substance erythromycin.
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06 February 2012 /Authorisation and supervision
Fewer organisations need a section 39 authorisation for retail sale of medical gases
In future, an organisation must actually sell medical gases to users in order to be considered a retailer of medical gases, which requires an authorisation under section 39 of the Danish Medicines Act.
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31 January 2012 /Authorisation and supervision
New revised Danish translation of the PhVWP's recommendation for the product information of ophthalmic beta-blockers
The European Pharmacovigilance Working Party, PhVWP, has once again revised its recommendation for the wording of the product information for ophthalmic beta-blockers. The package leaflet has been revised in order to bring the contraindications into agreement with item 4.3 of the summary of product characteristics.
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25 January 2012 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of Strattera (atomoxetine)
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for Strattera (atomoxetine). The Danish Medicines Agency has now translated this recommendation into Danish.
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20 January 2012 /Authorisation and supervision
Updating of summaries of product characteristics prompted by changed ATC codes for 2012
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 2012.
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10 January 2012 /Authorisation and supervision
Danish Medicines Agency resumes allocation of DCP time slots for the period July-October 2012
From 16 January until 6 February 2012, the Danish Medicines Agency accepts request for DCP time slots with Denmark as reference member state (RMS) for the period July-October 2012.
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02 January 2012 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for a number of active substances
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the following Certificates of Suitability (CEP): CEP 2001-341-Rev 02/Azathioprine, CEP 2003- 066-Rev 00/Ticlopidine HCl, CEP 2003-206-Rev 00/Haloperidol, CEP 2004-135-Rev 01/Risperidone, and CEP 2005-084-Rev 00/Diphenoxylate HCl. The manufacturer concerned is: RPG Life Sciences Limited, 25, M.I.D.C Land, Thane Belapur Road, 400 705 Navi Mumbai, Maharashtra, India.
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21 December 2011 /Authorisation and supervision
Recall of Vistide® deliveries causes no supply issues
The European Medicines Agency (EMA) has found that quality issues may have arisen in the production of the medicine Vistide® from the US company Ben Venue. EMA has therefore recommended that the company recall all affected deliveries (batches) of Vistide® until the quality can be assured.
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12 December 2011 /Authorisation and supervision
No supply problems caused by recall of batches of Luminity® and Ecalta®
The European Medicines Agency (EMA) has found that a quality problem may have occurred during the manufacturing of the two medicines Luminity® and Ecalta® from the US-based company Ben Venue.
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07 December 2011 /Authorisation and supervision
Danish translation of the PhVWP's recommendation for the product information of citalopram
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for citalopram. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Furthermore, marketing authorisation holders of citalopram must implement the new text by submitting variation applications for all relevant products.
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07 December 2011 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information concerning use of antipsychotics during pregnancy
The European Pharmacovigilance Working Party, PhVWP, has prepared a recommendation for the wording of the product information for antipsychotics. The Danish Medicines Agency has now translated this recommendation into Danish. The text is used to prepare new product information. Marketing authorisation holders of antipsychotics must implement the new text by submitting variation applications for all relevant products.
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25 November 2011 /Authorisation and supervision
Difference between the EU and the USA in authorisation of Avastin® (bevacizumab) for metastatic breast cancer
The U.S. Food and Drug Administration (FDA) has revoked the authorisation of Avastin® for use in treating metastatic breast cancer. In the EU, Avastin® is still authorised for treatment of metastatic breast cancer in combination with paclitaxel and in combination with gemcitabine.
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23 November 2011 /Authorisation and supervision
The use of Caelyx® should be limited due to quality issue
The European Medicines Agency (EMA) recommends doctors to limit the use of the medicine Caelyx® due to a potential quality issue during the manufacturing process at the US-based company Ben Venue.
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23 November 2011 /Authorisation and supervision
No supply problems caused by recall of batches of Busilvex®, Velcade® and Vidaza®
The European Medicines Agency has found that a quality problem may have occurred during the manufacturing of three medicines Busilvex®, Velcade® and Vidaza® at the US-based company Ben Venue. EMA has therefore recommended that the company recall all affected batches of the three medicines until the required quality assurance has been established.
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21 November 2011 /Authorisation and supervision
Withdrawal of a medicine due to possible counterfeiting
The pharmaceutical company Orifarm has – in consultation with the Danish Medicines Agency – decided to withdraw the medicine Truvada®. The withdrawal is caused by a potential presence of counterfeit packs on the market.
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15 November 2011 /Authorisation and supervision
Available time slots for DCP procedures with Denmark as Reference Member State (RMS)
The Danish Medicines Agency announces that some DCP procedure time slots have become available in November and December 2011.
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11 November 2011 /Authorisation and supervision
Translation of the PhVWP's recommendation for product information on Stevens-Johnson syndrome and toxic epidermal necrolysis
The European Pharmacovigilance Working Party, PhVWP, has drawn up a recommendation for the wording of the product information concerning Stevens-Johnson syndrome and toxic epidermal necrolysis for high risk medicines.
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09 November 2011 /Authorisation and supervision
Requirement for raised dots led to recalls after spot checks
In June 2010, the Danish Medicines Agency announced that packs of medicine are required to have the medicine's name and strength printed in Braille writing (raised dots) on the outer packaging no later than 30 October 2010 when the medicine is supplied to a wholesaler. The Danish Medicines Agency has carried out spot checks to follow up on the implementation of the requirement on Braille writing. 10 in 518 packs were deficient.
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04 November 2011 /Authorisation and supervision
Warning on illegal sale of donor sperm from saedbank.com
The Danish Medicines Agency has twice before warned against the sperm bank A. I. Sædbank, which yet again sells donor sperm illegally from the website www.saedbank.com. The website has been inactive for a period, but is now active again. According to the information on the website, the sperm bank supplies donor sperm for persons in the former Aarhus County.
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04 November 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance protamine sulphate
EDQM, the European Directorate for the Quality of Medicines and Healthcare, has suspended the CEP for the active substance protamine sulphate.
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01 November 2011 /Authorisation and supervision
Recall of medicines from patients: Truxal® 15 mg tablets with batch number 2282853
The Danish Medicines Agency has been informed that an error has occurred in the manufacturing of Truxal®, an antipsychotic medicine from Lundbeck. All users of Truxal® must therefore check the batch number on their packages. If the batch number is 2282853, the package must be returned to a pharmacy.
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01 November 2011 /Authorisation and supervision
Amendment of executive order on euphoriant substances
As of 27 October 2011, the substances 4-MEC, MPPP and N-ethylbuphedrone are comprised by the Danish executive order on euphoriant substances.
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28 October 2011 /Authorisation and supervision
Annual report on human tissues and cells shows continued rise in tissue establishment activity
The annual report on human tissues and cells is now available in English. It shows, among other things, that there were altogether 56 tissue establishments and 40 gynaecology clinics authorised to handle human tissues and cells in Denmark.
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27 October 2011 /Authorisation and supervision
Spot checks reveal insufficient information about antidepressants for pregnant and breast-feeding women
The Danish Medicines Agency has reported a number of companies to the police for having failed to update the package leaflet regarding pregnant and breast-feeding women's use of antidepressants of the SSRI type (selective serotonin reuptake inhibitors). At the same time, the Danish Medicines Agency has instructed the companies to withdraw any SSRIs with inadequate warnings.
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26 October 2011 /Authorisation and supervision
No cause for concern about influenza vaccination
A single batch of the influenza vaccine Preflucel has been withdrawn from the Danish market. 14 vaccines have been used in Denmark, and all other unused vaccines have been withdrawn from the market. There have been no reports of side effects in Denmark.
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26 October 2011 /Authorisation and supervision
Assessment times for authorisation of medicines for the first six months of 2011
We have just published our assessment times for authorisation of medicines for the first six months of 2011.
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24 October 2011 /Authorisation and supervision
Statement from EMA about Advagraf® and cardiovascular medicine
The European Medicines Agency, EMA, has decided to immediately recall some batches of Advagraf® (tacrolimus) 0.5 mg prolonged-release hard capsules from pharmacies and wholesalers from a number of countries across the EU. EMA has also looked into the possible link between the use of blood pressure lowering medicines of the type angiotensin II receptor antagonists and the occurrence of new incidences of cancer. EMA found that the evidence does not suggest any link with cancer.
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07 October 2011 /Authorisation and supervision
The EDQM has suspended the Certificate of Suitability for the active substance oxytetracycline
The European Directorate for the Quality of Medicines and Healthcare, has suspended the Certificate of Suitability for oxytetracycline.
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03 October 2011 /Authorisation and supervision
Changed practice for authorisations for wholesale distribution of medicines within the EU/EEA
The Danish Medicines Agency has changed its practice with respect to the format of authorisations for wholesale distribution of medicines within the EU/EEA. The change concerns the application form's Annex A.1 in which applicants are now only to indicate activities that the company carries out at its own address. Likewise, Annex A.1 of the wholesale dealer's authorisation will only list the activities performed at the company's own address.
