Category: Regulation & compliance
The MHRA make it clear: the UK will take a backseat in EU’s medicine licensing regime post-Brexit
Sarah-Jane Dobson
On 18 February 2020, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), updated its guidance on medicine licensing post-Brexit “Apply for a licence to market a medicine in the UK”. The update provides further clarity on the UK’s status in the licensing process now that Brexit has taken place.
E-labelling: are EU ready for the digital age yet?
Tracey Bischofberger and Julia Maskell
A new public consultation on the labelling of fragrance allergens could open the door to e-labelling in the EU.
EU public consultation on RoHS: have your say!
The European Commission is currently holding a public consultation as part of its evaluation of Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic equipment. This is an important opportunity for stakeholders to have their say.
Highlights from the ICPHSO International Symposium, Dublin 2019
Last week, product safety professionals from around the globe attended the ICPHSO International Symposium in Dublin. We are pleased to bring you some of the highlights coming out of the many interesting sessions.
Can we fix it? Yes we can! New EU right to repair laws adopted
Legislation setting out new EU-wide rules on reparability, availability of spare parts and access to repair and maintenance information for certain appliances (such as refrigerators, dishwashers, washing machines and washer-dryers) has been adopted and will apply from 2021. These measures have implications for manufacturers, importers and authorised representatives of affected products placed on the EU market. There have also been calls to extend these requirements to other durable non-energy related consumer products. Manufacturers of products not affected by these new laws need to keep an eye on developments in this area.
Tracey Bischofberger
AV/ICT equipment: don’t let standards slip! New single safety standard IEC 62368 coming into force
A new single safety standard IEC 62368 is coming into force that will replace existing safety standards for ICT and AV equipment. This will have important implications for many product manufacturers and importers. Businesses need to start thinking about this and making preparations now.
Tracey Bischofberger
OPSS I did it again – further guidance published to prepare businesses for a No Deal Brexit
The Office for Product Safety and Standards (OPSS) has published additional detailed guides for business on specific product safety regulations in the event of a No Deal Brexit.