Parallel import meaning

What is the background to the consultation? IP rights confer exclusive monopolies on their owners. Ordinarily, those protections stop others from selling, trading in, or importing products that infringe the monopoly. Exhaustion The principle of exhaustion curbs that exclusivity for items already placed on the market with the rights holder’s consent. Once goods are put on the relevant market with permission, the IP proprietor cannot object to their sale, subsequent dealing, or import. A central issue within exhaustion is identifying the relevant market; by placing goods into that market, the proprietor’s rights are exhausted. This matters especially when considering the entitlement to import products covered by IP rights. Many rights holders aim to command premium prices in high-income territories, yet they also wish to supply lower-income markets that cannot bear such premiums. The difficulty arises when those lower-priced goods reach high-income markets, undercutting authorised channels and eroding profit margins. Unauthorised imports—known as parallel imports because they occur alongside authorised imports—therefore create challenges for rights holders. This focus on market...

Parallel trade of goods This principle, in effect, underpins the parallel movement of goods. Parallel trade describes the import and export of authentic goods that have already been lawfully placed on the market, where the IP owner’s rights are exhausted. Within the EU, the European Economic Area (EEA) applies a regional exhaustion model. With limited exceptions, once goods are put on the EEA market—either by the IP owner or with the owner’s consent—those rights are spent; in practice, the owner cannot manage or oppose further dealings in those goods. The IP rights in goods first placed on the market in the UK have not been treated or recognised as exhausted in the EU since: the UK left the EU on 31 January 2020; the Brexit transition period ended on 31 December 2020; and the UK is no longer a member of the EEA. Following an extensive and lengthy consultation, the UK government confirmed that the UK will continue to participate,...

The consultation The Health and Safety Executive (HSE) — the authority responsible, within its health and safety remit, for regulating chemicals in the UK — has released a consultation paper on chemicals policy. It concentrates on three key strands: the regulation of biocides the classification, labelling and packaging (CLP) of chemicals the export and import of hazardous chemicals, including prior informed consent (PIC) The background The consultation is largely a consequence of Brexit. For instance, before the UK’s departure, the European Chemicals Agency (ECHA) handled approvals for biocidal products on the EU single market through the EU Biocidal Products Regulation (Regulation (EU) 528/2012), which sets rules for marketing and using biocides across Europe. Since leaving the European Union, this responsibility sits with HSE for Great Britain (not the whole UK, as Northern Ireland continues to apply certain EU chemicals rules under the Windsor Framework). In parallel with biocides, ECHA administers European CLP under Regulation (EC) 1272/2008 to ensure EU classifications...

The legal framework This Practice Note outlines the rules of trade mark law governing parallel trade. Parallel imports—often called ‘grey market’ products—are authentic items put on sale by, or with the approval of, the rights holder, but later brought into a specific market for resale without that holder’s permission. They are distinct from counterfeits or ‘black market’ items. For guidance on counterfeit goods, see: Anti-counterfeiting—overview. Key rules derive from the Treaty on the Functioning of the European Union (TFEU) and Directive (EU) 2015/2436, which regulates national trade mark registrations across Member States and is given effect in the UK through the Trade Marks Act 1994 (TMA 1994). This Practice Note details how UK trade mark law addresses parallel imports. It examines the circumstances in which a trade mark proprietor’s rights are exhausted and when the rights holder can block grey market goods from being offered in the UK. It also clarifies how the post-Brexit EU parallel import regime interacts with UK rules, and the practical effects for items first...

This Practice Note outlines the law on marketing authorisations (MAs) for medicinal products intended for the UK market following the close of the Brexit transition period (11 pm (GMT) on 31 December 2020, termed in UK law ‘IP completion day’). It covers: exemptions from the need to hold an MA (eg ‘specials’, investigational medicinal products (IMPs), and the Early Access to Medicines Scheme (EAMS)) the various categories of MA the licensing pathways to secure an MA in the UK, Great Britain (GB), or Northern Ireland (NI) (eg Northern Ireland Medicines and Healthcare products Regulatory Agency (MHRA) Authorised Route (NIMAR), Innovative Licensing and Access Pathway (ILAP), unfettered access, the 150‑day accelerated national procedure, rolling review, the reliance routes on EU authorisations now integrated into the International Recognition Procedure (IRP), Project Orbis and Access Consortium) information on applying the Ireland/Northern Ireland Protocol as amended under the Windsor Framework the offences and penalties arising from breaches of these provisions Governing law The...