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Regulation/Legislation (Health)

Set Alert for Regulation {Health}

Poland Gives Green Light To Switches From Teva and Polpharma

Teva and Polpharma's OTC operations in Poland are set to received a boost with the approval of two switches by national medicines regulator URPL. Polish consumers can now get OTC access to additional treatments for hay fever and cough. 
Prescription To Otc Switch Poland OTC Drugs

German Industry Tries To Nip Homeopathy Debate In The Bud As France Decides In Favour Of De-Reimbursement

As France decides to de-reimburse homeopathic medicines, discussions about whether this should be applied to Germany are being re-opened by politicians and high-profile representatives from the country's statutory health insurance system. Industry has responded by saying "no" to de-reimbursement, as the German system allows consumers to choose between insurers based on their views of homeopathy. 
Health OTC Drugs Reimbursement

US FDA Regulatory Roundup: Ecometrics GMP Warning, Altaire Ophthalmic Recalls

Contract manufacturer Ecometics may have distributed adulterated OTC drugs due to inadequate removal of residues from manufacturing equipment it also uses to make insect repellent, FDA says; and Altaire Pharmaceuticals expands its recall of OTC and Rx ophthalmic products due to a lack of sterility assurance.

OTC Drugs FDA Regulation

Regulation

Set Alert for Regulation {Health}

Latest From Health & Regulation

Dutch Firms Not Updating Product Info Fast Enough Following Safety Alerts

OTC marketing authorization holders in the Netherlands must respond more quickly to safety alerts issued at EU level which require product information updates, says regulator MEB.
Netherlands Drug Review

Health And Wellness Products Trademark Review 15 October, 2019

Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.


OTC Drugs Dietary Supplements

OTC Zantac Recall: Sanofi Heeds To Potential Ranitidine Contaminant

Firm opts for recall "as a precautionary measure due to inconsistencies in preliminary test results of the active ingredient used in the US and Canadian products." Other firms marketing ranitidine in US have started recalls due to concerns about NDMA since potential problem became known in September.

OTC Drugs Recalls
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Legislation

Set Alert for Legislation {Health}

Latest From Health & Legislation

India Poised To Create OTC Drug Category In Historic Move

India is preparing to amend its Drugs and Cosmetics Rules to create an OTC category for the first time in a move which would transform the country's consumer healthcare market. 
India Legislation

Health And Wellness On Capitol Hill: Monograph Reform, Wyden On CBD Rule, OTC Daily Contraceptive Access

Energy and Commerce members try again on monograph; Democrats want to ensure OTC oral contraceptive access; Wyden asks for faster CBD rulemaking at FDA; and House passes FDA's FY 2020 funding.

OTC Drugs Dietary Supplements

Need Private Meeting For Sunscreen MUsT Details? Just Ask, FDA Says

"FDA meetings with an individual manufacturer regarding inclusion of ingredients in the monograph ... could have broad applicability, and hence are generally public," CDER says. But, "regulations permit any person to request a private meeting, and FDA will make reasonable efforts to accommodate such requests."

OTC Drugs FDA
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