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EU Regulatory News Round Up: NSAIDs During Pregnancy, Estragole Excipients, ePIs

 
• By David Ridley

CMDh receives applications to change how NSAIDs are recommended for use during pregnancy; HMPC warns against use of estragole-containing excipients in herbals; EMA adopts new EU common standard for electronic product information on medicines marketed within the region.

Illustration of an European Union long shadow flag with a dart board
• Source: Shutterstock

Several national and European Union variation applications have been received to change the wording of the recommendation of the use of non-steroidal anti-inflammatory medicines during pregnancy, according to the minutes of the most recent meeting of the European Medicines Agency’s Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) on 25-27 January 2022.

The submissions are based on a recent US Food and Drug Administration recommendation to avoid the use of NSAIDs in pregnancy at 20 weeks or later as they may cause rare but serious kidney problems in an unborn baby

More from Europe

Supplementation Unlikely To Help With Hereditary Hair Loss, Says German Agency

 
• By David Ridley

Germany’s Federal Institute for Risk Assessment says that there is "no evidence that people with androgenetic alopecia have special dietary needs or a special nutrient requirement.”

US Tariffs Pose ‘Existential Threat’ To EU Medical Devices Industry

 
• By David Ridley

AESGP, MedTech Europe and other associations representing medtech companies including manufacturers of self-care devices call for such products to be included in European Commission proposals for “zero-for-zero” trade in industrial goods between Europe and the US.

OTCs Are ‘Beacon Of Hope’ For Austrian Pharmacy

 
• By David Ridley

Just under half of Austrian pharmacists surveyed by Elpato Medien are “convinced that the OTC business will ensure the survival of their pharmacy.”

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

More from Geography

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Plenty For Industry To Do As EU Wastewater Directive Faces Legal Challenges

 
• By David Ridley

Engaging with EU member state legislators, stressing the impact of national EPR systems on the accessibility, availability, and affordability of medicines, reformulating products to reduce their financial contribution, and lobbying for expanding the scope of EPR schemes to include other polluting industries are all ways that the European consumer health industry can try and influence the way that the revised Urban Wastewater Treatment Directive is transposed into national legislation, law firm Mason Hayes & Curran explains.

French Agency Proposes Effective EU Ban On CBD In Foods And Cosmetics

 
• By David Ridley

France's food safety regulator ANSES is proposing a reproductive toxicity category 1B classification for CBD under the EU's CLP regulation, which would mean an effective ban on CBD in cosmetics and foods. However, French hemp industry association UIVEC hopes that new evidence coming out of a European Commission review will put the issue to bed before it gets that far.