Regulatory in brief | EMA/HMA, CBD, loperamide

Regulatory in brief | EMA/HMA, CBD, loperamide

8 December 2020 - Deborah Wilkes

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have published a joint strategy to 2025, the European Court of Justice (ECJ) has released a judgement on cannabidiol (CBD), and Denmark has made changes to the sale of loperamide medicines.

Joint strategy for Europe’s medicines agencies

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for the next five years.

The EMA says the strategy details how the European medicines regulatory network can continue to enable the supply of safe and effective medicines in the face of challenges posed by ever-accelerating developments in science, medicine, digital technologies and globalisation as well as emerging health threats, such as the COVID-19 pandemic.

Six priority areas for the network are covered:

  • Availability and accessibility of medicines
  • Data analytics, digital tools and digital transformation
  • Innovation
  • Antimicrobial resistance and other emerging health threats
  • Supply chain challenges
  • Sustainability of the network and operational excellence

ECJ rules on CBD

The European Court of Justice (ECJ) has ruled that member states of the European Union “may not prohibit the marketing of cannabidiol (CBD) lawfully produced in another member state when it is extracted from the Cannabis sativa plant in its entirety and not solely from its fibre and seeds”.

The ECJ added that the prohibition “may however be justified by the objective of protecting public health but must not go beyond what is necessary in order to attain it”.

“A decision to prohibit the marketing of CBD, which indeed constitutes the most restrictive obstacle to trade in products lawfully manufactured and marketed in other member states, can be adopted only if that risk appears sufficiently established,” added the ECJ.

As part of the judgement, the ECJ concluded that CBD “cannot be regarded as a narcotic drug” and can therefore be freely sold in the European Union.

“Unlike tetrahydrocannabinol (THC), another hemp cannabinoid, the CBD at issue does not appear to have any psychotropic effect or any harmful effect on human health,” added the ECJ.

The judgement was made in relation to criminal proceedings in France involving the import of CBD for use in electronic cigarettes. The CBD was produced in the Czech Republic from hemp plants grown lawfully and using the complete plant, including the leaves and flowers. Under French legislation, only the fibre and seeds may be used.

Denmark restricts loperamide sales

The Danish Medicines Agency is restricting sales of medicines containing the antidiarrhoeal loperamide with the aim of reducing overuse and incorrect use.

Loperamide medicines can now only be purchased by people over 18 years of age and the maximum pack size for general-sale retail outlets is 20 pieces.

Packs containing more than 20 pieces have been put in the HA18 non-prescription category which means they can only be sold in pharmacies.

Packs containing 20 or fewer pieces are now in the HX18 non-prescription category which means they can be sold in non-pharmacy retail outlets but the buyer has to be at least 18 years of age and only one pack can be purchased.

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