Starting with 1 March 2016, the changes to License Conditions for Conducting Commercial Activities in Import of Medicines (the License Conditions), which introduce a set of requirements to the companies importing drugs into Ukraine for further sale or use in manufacturing of finished pharmaceuticals, have come into force.
Let us remind that the License Conditions themselves came into effect in 2013; however, since the business was not ready to comply with some of requirements, the effect of certain provisions was postponed for March 2016.
Therefore, the importers of pharmaceuticals now have to comply with the additional conditions as follows:
- Drugs are to be imported under a trilateral agreement between the manufacturer/supplier and the Marketing Authorization (MA) holder. Such agreement, inter alia, must contain the conditions for storage, transport, quality control, handling of complaints, withdrawal from circulation, etc.
- The importer (or the manufacturer or MA holder) has to exercise stability control over the specific drug that has entered the market, whereby the respective obligations have to be foreseen in the above agreement.
- The importer must introduce and implement a pharmaceutical quality system that includes the good manufacturing practice, the good distribution practice, the good practices for storage and quality risks management.
- An agreement must be executed to carry out any outsourcing activities.
- The importer has to keep reference and/or retention samples of each batch of the finished products. Such samples are to be kept on the importer’s premises for at least one year after the expiration date of the medicinal product.
It should be noted that a draft Decree of the Cabinet of Ministers has been prepared, whereby it is proposed that the effect of the License Conditions be delayed until 1 March 2018. The said draft eliminates certain problems existing in the effective version of the License Conditions. In particular, the condition to execute trilateral agreement is revoked. Instead, the importer may execute separate agreements with the manufacturers/suppliers and MA holders. It also proposes to readjust the requirements to the pharmaceutical quality system in order to avoid duplication of the already existing requirements to the quality control during import in the relevant Cabinet of Minister’s Decree.
In regard to the above, the proposal of the State Administration of Ukraine on Medical Products is important, as it practically declared that it would not apply the above provisions of the License Conditions in the course of its license inspections and preparation of decisions based on the outcome thereof.