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30-8-2018

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Grant agreement for piloting the Framework Partnership Agreement between the National data provider organisations in Cyprus and EFSA – Final report

Published on: Tue, 07 Aug 2018 00:00:00 +0200 Cyprus alongside with another 4 countries has participated successfully in the Grant Agreement GP/EFSA/DATA/2016/01‐GA 02, entitled: “Strategic Partnership with Cyprus on Data Quality”. The project was co‐financed by EFSA, aiming to help both EFSA and data providers from Member States to possess data of high quality in a quantitatively manageable way. The main objective of the grant agreement was the establishment of the data governance, coordination and imp...

Europe - EFSA - European Food Safety Authority Publications

14-8-2018

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix, LLC Issues Voluntary Nationwide Recall of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend, Due to High Microbial Loads

World Organix LLC, is voluntarily recalling lot: 112710 of Blissful Remedies Red Maeng Da 100% Mitragyna Speciosa capsules, Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, Blissful Remedies 4 Hour Chill Slow Motion Blend to the consumer level. These products have been tested by the U.S. Food and Drug Administration (“FDA”) and found to be contaminated with High Microbial Loads. Additionally, this serves as a update to a previous press release posted on June 30th 2018, concerning Blissful...

FDA - U.S. Food and Drug Administration

30-7-2018

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

ANSES recommends that certain populations avoid the consumption of food supplements containing melatonin

Under the national nutrivigilance scheme, reports of adverse effects likely to be associated with the consumption of food supplements containing melatonin have been brought to the attention of ANSES. A retrospective analysis of these reports, combined with the considerable level of consumption of this type of supplement, led ANSES to conduct an assessment of the potential health risks. In its Opinion of February 2018, the Agency highlighted the existence of populations and situations at risk, for which t...

France - Agence Nationale du Médicament Vétérinaire

18-7-2018

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

"Anti-pollution" masks: not enough data to demonstrate a health benefit and justify recommending their use

In a context where prevention of ambient air pollution is a real public health issue, questions are regularly asked about the value of recommending that the population wear personal protective equipment. This led ANSES to assess the potential health benefits of wearing "anti-pollution" masks. Its expert appraisal revealed a lack of data demonstrating a health benefit. To reduce the health impacts associated with ambient air pollution, the Agency reiterates the importance of prioritising action at the sou...

France - Agence Nationale du Médicament Vétérinaire

17-5-2018

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition

Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition

FDA statement on certain tactics drug makers may be pursuing to delay generic competition

FDA - U.S. Food and Drug Administration

13-3-2017

EuropharmaDK regains its authorisation

EuropharmaDK regains its authorisation

The Danish Medicines Agency has decided to lift the suspension of EuropharmaDK's manufacturing and importation authorisation, following the outcome of a follow-up inspection of EuropharmaDK ApS on 8 March where the Danish Medicines Agency ascertained that the critical findings had been corrected.

Danish Medicines Agency

4-1-2016

The Danish Medicines Agency has a new website

The Danish Medicines Agency has a new website

Today, the Danish Medicines Agency launched its new website – laegemiddelstyrelsen.dk/en – where you can read about and subscribe to news about licensing and supervision of medicines, side effects, reimbursement, pharmacies and medical devices.

Danish Medicines Agency

28-1-2014

Time slots for DCP procedures with Denmark as Reference Member State (RMS)

Time slots for DCP procedures with Denmark as Reference Member State (RMS)

The Danish Health and Medicines Authority wishes to inform future applicants of the possibility to request for a time slot to applications for marketing authorisations through the decentralised procedure (DCP) where Denmark is acting as reference member state (RMS).

Danish Medicines Agency

22-2-2012

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

Changed criteria for single reimbursement for osteoporosis medicines other than alendronate

As of 5 March 2012, it will only be possible to obtain a single reimbursement grant for the other medicines used in osteoporosis treatment for patients that cannot use alendronate. The criteria for single reimbursement are changed because of the large price gaps between the different medicines, where the reimbursement price of alendronate is by far the lowest.

Danish Medicines Agency

21-9-2018

Regulatory and procedural guideline:  Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

Regulatory and procedural guideline: Draft qualification opinion on stride velocity 95th centile as a secondary endpoint in Duchenne Muscular Dystrophy measured by a valid and suitable wearable device, draft: consultation open

This report provides a final agreed draft Context of Use for public consultation describing where Stride Velocity measured at the ankle 95th Centile is deemed by CHMP as an appropriate endpoint in studies to support regulatory decision making on medicines for the treatment of Duchenne Muscular Dystrophy (DMD), together with CHMP’s scientific consideration of the submission leading to the draft opinion. The document also includes the questions posed by the applicant and also raised by CHMP to the Applic...

Europe - EMA - European Medicines Agency

12-7-2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

TGA presentations: The new Code - where are we at? 12 & 13 June 2018

These presentations provided an update on the implementation of the new Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

25-5-2018

The new Code - where are we at?

The new Code - where are we at?

Webinar and information session on the implementation of the Therapeutic Goods Advertising Code and complaints system

Therapeutic Goods Administration - Australia

7-5-2018

News and press releases:  Two years of PRIME

News and press releases: Two years of PRIME

Driving innovation to where it is most needed

Europe - EMA - European Medicines Agency