On November 28, 2018 the Federal law of November 28, 2018 No. 449-FZ “On amendments being made to separate legal acts regarding introduction of drugs into commercial turnover” (the “Law”) was published on the official web portal of legal information. The main changes introduced by the Law are as follows:
1. The Law excludes drugs from the declaration and mandatory certification procedures
According to the changes introduced by the Law the sphere of drugs circulation is excluded from the Federal law of December 27, 2002 No. 184-FZ “On technical regulation”.
2. The Law stipulates special requirements in connection with introducing medical drugs (“Medicines”) into commercial turnover1
The Law stipulates list of documents to be submitted to the federal executive authority, which carries out control and supervision functions in the sphere of healthcare, before the introduction of each line or batch of Medicine into commercial turnover:
- For a Medicine produced within the Russian Federation: manufacturer submits (1) drug manufacturer’s document confirming the quality of the Medicine and (2) confirmation of Medicine’s compliance with the requirements established at its state registration on behalf of the drug manufacturer’s authorized person;
- For a Medicine being imported into the Russian Federation: company importing the Medicine submits (1) drug manufacturer’s certificate confirming the Medicine’s compliance with the requirements of a drug monograph2 and (2) confirmation of Medicine’s compliance with the requirements established at its state registration on behalf of the representative of the company importing the Medicine and being duly authorized by the foreign drug manufacturer.
3. The Law establishes additional requirements for the introduction into commercial turnover of the first three drug lines or batches3
The Law stipulates requirement for additional document to be submitted for the first three lines or batches of drug, which is produced within the Russian Federation for the first time or being imported into the Russian Federation for the first time, namely — test protocol for drug line or drug batch compliance with performance requirements established by the regulatory documents. The tests are to be performed by the accredited state-funded institutions.
4. The Law hardens the rules for immunobiological drugs entering in commercial turnover4
Each line or batch of immunobiological drug can be introduced into commercial turnover only upon the relevant permit issued by the federal executive authority, which carries out control and supervision functions in the sphere of healthcare, based on the statement of compliance of such immunobiological drug’s line or batch with the requirements established at its state registration issued by state-funded institutions. This requirement is applicable to immunobiological drugs both produced within the Russian Federation and imported into the Russian Federation.
5. The Law introduces the mandatory notification on suspension or termination of drug production or drug import into the Russian Federation
Drug manufacturers or companies importing drugs into the Russian Federation at least 1 year before the planned suspension or termination of drugs production or drugs importation into the Russian Federation must notify the following state authorities:
- Federal executive authority, which carries out control and supervision functions in the sphere of healthcare;
- Federal executive authority, which carries out functions in the sphere of manufacturing authorization.
Under the information posted on the official website of the Russian Government, the Law is intended to establish a more effective legal control of relations regarding development, implementation and compliance with requirements in the sphere of medical drugs circulation, namely, creation of a “final” control mechanism in respect of drugs entering into commercial turnover in the Russian Federation.
The Law provisions will come into force on November 29, 2019, with the exception of the provisions on mandatory notification on suspension or termination of drug production or drug import into the Russian Federation, which have already entered into force starting from November 28, 2018 (the date of the Law’s official publication).
1Except for the following drug types: (1) intended for clinical trials; (2) intended for examination of medicinal products for state registration of drugs; (3) unregistered drugs intended for medical treatment according to vital indications of a particular patient
2 If there is no drug monograph — then compliance with regulatory documents has to be confirmed
3 Except for the following drug types: (1) intended for clinical trials; (2) intended for examination of medicinal products for state registration of drugs; (3) unregistered drugs intended for medical treatment according to vital indications of a particular patient
4 Except for the following immunobiological drug types: (1) intended for clinical trials; (2) intended for examination of medicinal products for state registration of drugs; (3) unregistered drugs intended for medical treatment according to vital indications of a particular patient