1. Pharmaceuticals and healthcare
The procedure for the state registration of medicines has changed
Instead of the GMP certificate, a manufacturer may, starting from June 2018, provide the registration authority with a copy of an inspection decision issued by the responsible state authority.
It is not permitted to register two trade names of the same medicine for the same manufacturer.
The Russian Ministry of Healthcare can suspend the circulation of a medicine in the following cases:
- the procedure for the production of the medicine differs from that declared in the registration dossier;
- the medicine was produced at a production site that was not indicated in the registration dossier;
- when it puts the medicine onto the market, the manufacturer cannot confirm that the medicine conforms to the requirements established when it was registered.
(Federal Law No. 140-FZ ‘On amending the Federal Law ‘On the circulation of medicines’ dated 4 June 2018 )
A license is required to produce biomedical cell products
Producers of biomedical cell products must obtain relevant licenses starting from August 2018. To secure fulfilment of the requirement, state control has been introduced in the sector, which allows for audits to be conducted.
(Federal Law No. 323-FZ ‘On amending certain items of Russian legislation regarding the circulation of biomedical cell products’ dated 3 August 2018)
A prohibition has been introduced on returning food products not sold within a certain period
Starting from 9 December 2018, retail chains will be prohibited from including provisions in contracts with suppliers under which the latter must compensate to the retailer expenses on the disposal or destruction of food products that have not been sold.
Retail chains are also prohibited from imposing conditions on the supplier to return food products whose shelf life exceeds 30 days. If such shelf life is 30 days inclusive, there is a complete ban on having such products replaced with similar ones or having their value reimbursed.
The terms and conditions of supply agreements must be brought into line with the new rules by 7 June 2019.
(Federal Law No. 446-FZ ‘On amending article 5 of the Federal Law ‘On developing agriculture’ and the Federal Law ‘On the basic principles concerning state regulation of trade in the Russian Federation” dated 28 November 2018)