New regulations on medical equipment

On 6 November 2019, the Ministry of Health and its State Health Care Accreditation Agency approved renewed medical equipment regulations based on EU Regulation 2017/745 and EU Regulation 2017/746.

Importantly, some products with no intended medical purpose (e.g. contact lenses that do not affect eyesight, equipment used for cosmetic surgery) will now be considered ‘medical equipment’. This means that they will have to comply with the regulations for medical equipment. The new law also introduces new requirements for such equipment, e.g. it will have to be marked with a Unique Device Identification (UDI) to help identify and trace devices. Manufacturers will also be required to operate a quality management system.

The new regulations come into force on 26 May 2020 but their full text is not yet available online.

Source:

  1. Press Release by the Ministry of Health, available in Lithuanian through link.

List of prohibited medicinal products containing ranitidine is updated

On 12 November 2019, Lithuania’s State Medicines Control Agency (SMCA) issued a decision updating the list of prohibited medicinal products that contain ranitidine hydrochloride. Ranitidine is used to reduce stomach acid. The supply of medicinal products containing this substance was prohibited in September 2019 since it was found it could cause cancer. In November, the SMCA prohibited more medicinal products that were not banned previously.

The list was updated to reflect new recommendations received from the European Directorate for the Quality of Medicines & Healthcare and the fact that companies (or their representatives) responsible for registration of certain medicinal products had not provided documents confirming that the product does not contain traces of N-nitrosodimethylamine (NDMA), the carcinogenic compound that can be found in ranitidine.

A full list of medicinal products banned in November can be found on the SMCA website, available in Lithuanian through link.

Source:

  1. Press release by the State Medicines Control Agency of Lithuania, available in Lithuanian through link.