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USTRNonrulemakingUSTR-2012-0028

US-EU Regulatory Compatability

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Consumer Healthcare Products Association filings
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Consumer Healthcare Products Association filed 1 comment on this docket between Nov 2, 2012 and Nov 2, 2012. 43 other organizations filed here. The comment window closed 5009d ago.

What Consumer Healthcare Products Association filed (1)

Nov 2, 2012· Comment from David Spangler, Consumer Healthcare Products Association· USTR-2012-0028-0012

Re: U.S.-EU Regulatory Compatibility, Request for Comments from the Public, 77 Fed. Reg. 59702 (September 28, 2012) In the September 28, 2012, Federal Register, the Office of the United States Trade Representative invited comments on how to promote greater transatlantic regulatory compatibility, including in particular economic sectors. The Consumer Healthcare Products Association (CHPA) is the national trade association representing manufacturers and distributors of over-the-counter (OTC) medicines and dietary supplements in the United States. Many of CHPA's member manufacturers also operate or distribute OTC medicines and dietary supplements in EU Member States, and we cooperate closely with a related association in Europe, the Association of the European Self-Medication Industry (AESGP), on matters of mutual interest. The U.S. and EU Members States have many OTC medicines and active pharmaceutical ingredients in common. As such, we have an interest in the subject matter of the USTR notice. In the U.S., all medicines, including OTC or nonprescription medicines, are primarily regulated by the Food and Drug Administration. See Federal Food, Drug, and Cosmetic Act (21 USC 301 et seq.). In the EU, while individual Member States have drug regulatory authorities, harmonization of a single market is well advanced, with legislation covering the approach within EU Member States for medicinal products for human use, including OTC medicines, and establishing a European Medicines Agency. See Directive 2001/83/EC, and Regulation (EC) No 726/2004. In the attached file, AESGP and CHPA would like to draw attention to 3 specific topics for greater transatlantic compatability. Respectfully, David C. Spangler Consumer Healthcare Products Association

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