Medicines

The Law of Ukraine No 2469-IX "On Medicines" of 28 July 2022; (115 page(s), in Ukrainian)

The Law governs legal relationships in the field of medicines, covering their development, preclinical and clinical trials, state registration, manufacturing, prescription, use, import, wholesale and retail trade, distance selling, pharmaceutical quality control, pharmacovigilance, and defines the rights and responsibilities of legal entities and individuals, state authorities and officials in this sphere.

The Law provides for the following:

Harmonizing Terminology: Eliminating terminological inconsistencies in legislation and aligning terminology with EU legislation.

Medicine Placement Rules: Establishing rules for the placement of medicines intended for human use, considering special requirements for reference and generic medicines, homeopathic and traditional herbal medicines, pediatric, high-tech, and orphan medicines, etc.

Licensing Provisions: Setting special provisions for licensing the manufacture, wholesale trade, and import of medicines (excluding active pharmaceutical ingredients).

Labelling and Safety: Determining the content of medicine packaging labels and requirements for their safety characteristics.

Medicine Classification: Streamlining the classification of medicines.

Distance Selling Rules: Establishing rules for the distance selling of medicines to consumers.

Advertising and Information Policy: Defining specific provisions for advertising and detailing information policies related to medicines.

Pharmacovigilance Regulation: Adopting a comprehensive approach to regulating the pharmacovigilance system.

Supervision and Control: Ensuring the efficiency of supervision and control mechanisms in the circulation of medicines, and liability of persons for violation of the legislation on medicines, ensuring consumer rights protection in this sphere.

The Law aims to ensure public health protection in Ukraine by providing access to effective, high-quality and safe medicines, as well as to implement specific provisions of EU legislation on medicines for human use.

The Law also establishes that the registration certificate for a medicine issued before the entry into force of this Law and having a limited validity period shall remain valid for the period specified in the certificate.

A registration certificate for a medicine issued before the entry into force of this Law and having an unlimited validity period shall remain valid indefinitely after the entry into force of this Law. Such registration certificate shall be replaced by an extract from the State Register of Medicines upon the application of the registration holder (or their representative in Ukraine) free of charge within five years from the date of the Law's entry into force. The extract shall be issued without any amendments to the registration materials and/or without any requirements to provide additional materials.

Medicines registered in Ukraine before the entry into force of this Law may be placed on the market within five years from the date of entry into force of this Law and remain on the market until their expiry date in accordance with the legislation in force before the Law's entry into force, without any prohibitions or restrictions being applied to them for these reasons.