Home Submenue Product Regulation & Liability

Product Regulation & Liability

The vaccine liability case – ECJ lowers the standard of proof

In a recent judgment, the ECJ held that where there is a lack of scientific consensus, proving that a vaccine is defective may be established by "serious, specific and consistent" evidence, so long as national courts ensure that the burden of proof is not being disregarded.

Progress on product safety – UK Government publishes recommendations of its Working Group

The tragic Grenfell Tower firebrings into sharp focus the importance of having an effective product safety system in place. Prior to this event, the UK Government was already reviewing the UK's product safety and recall system.

Brexit update for product manufacturers and sellers

Following the start of negotiations between the United Kingdom and the remaining 27 EU Member States, there are two new Brexit-related publications which will be of interest to those manufacturing or selling products on the UK and EU-27 markets.

Automotive and Electrical Equipment BNST Use Extension in Canada

Environment Canada appears to be stepping back from its ambitious goal of the virtual ban of benzenamine, N-phenyl-, reaction prod­ucts with styrene and 2,4,4-trimethylpentene (BNST) in Canada.

Increased Enforcement of U.S. Forced Labor Prohibition

The Trade Facilitation and Trade Enforcement Act of 2015 effectively eliminating a longstanding loophole in the United States’ general prohibition against the importation of goods made with forced labor. As a result, U.S. companies have witnessed a resurgence of U.S. Customs and Border Protection detentions/seizures.

What are the implications of Brexit for EU product compliance?

If you manufacture, import or supply products in, to or via the UK in some capacity, you may well already be considering how Brexit may impact the application of product-related laws to your business. In this article we look at what might happen to product laws under the different suggested models for the UK/EU-27 relationship so that you can start considering how your business may be affected.

Bill in Congress Would Increase Reporting of Hazards Related to Medical Devices

On Wednesday, June 8, 2016, a bill was introduced in Congress that would, if passed, amend the Federal Food, Drug, and Cosmetic Act to require physicians and physicians’ offices to submit reports to FDA on hazards relating to medical devices.

Thailand: FDA Clamps Down on Online Sale and Advertising of Drugs

The Deputy Secretary General of the Food and Drug Administration recently announced that the FDA had received complaints from consumers, asking it to inspect the sale and advertising of drugs on an online shopping website.

Publication of the Blue Guide 2016: Implications for online sales and other significant changes

The EU Commission published an updated version of 'The "Blue Guide" on the implementation of EU product rules', the most authoritative EU guidance on the application of product-related directives and regulations to goods destined for the EU market.

Importers into the EU must know chemicals in product

With a long-awaited decision, the European Court of Justice (ECJ) causes headache and turbulences to manufacturers, importers and distributors of all kinds of products to be placed on the market in the European Union.

Send this to a friend