The new rules on the medicines interchangeability No. 1360 (hereinafter – the Rules) enacted by the Russian Government have entered into force on 9 September 2020 .
The Rules do not cover herbal and homeopathic medicines.
According to the Rules, medicines are regarded as interchangeable if the following criteria are met:
- Equivalence (biosimilar comparability) of the qualitative and quantitative pharmaceutical substances characteristics or comparability of the vaccines antigenic composition
- Dosage form equivalence
- Excipients equivalence or comparability
- Identical mode of administration
- Compliance of the manufacturer with the GMP requirements
Medicines are also referred to as interchangeable if:
- there are no clinically significant differences in pharmacokinetics and/or efficacy and safety of a generic during bioequivalence/therapeutic equivalence studies
- different salts, esters, isomers, or other derivatives of the same active substance are used
- dosage forms or used excipients are different
To identify medicines as interchangeable expert committee compares medicines specification files, bioequivalence/therapeutic equivalence studies reports, medical use instructions.
To determine the interchangeability of biological, combined, non-dosed medicines, as well as medicines for parenteral nutrition, INN/group/chemical names adequacy and adequacy of indications and contraindications in the medical use instructions are taken into account.
Under the Rules combined medicines and combination of separate medicines with the same INN as combined medicines may be regarded as interchangeable.
Generics (biosimilars) interchangeable with the one referent medicine are interchangeable.
The expert committee decision on the medicines interchangeability shall be drawn up in the form approved by the Russian Government. The interchangeability examination shall be conducted within 30 days from the medicine registration date, except additional documentation is requested from the MA holder.
The list of interchangeable medicines is placed on the official State medicines register website and updated at least once a month. The Russian Health Ministry uploaded the first list of the interchangeable medicine on 30 June 2020.
The Rules also stipulate the administrative way of appeal against the expert decision. An appeal is filed by the MA holder with the user account within 20 working days from the expert decision date.
The new Rules establish clear criteria for the medicines interchangeability, and also describe the examination procedure in detail. The right to appeal the expert decision is of importance. However, a question of whether the Rules will be applied effectively remains open.
1The previous rules on the medicines interchangeability No. 1154 were enacted by the Russian Government on 28 October 2015