A new order for quality control of medicinal products in wholesale and retail trade

November 26, 2014 at the Ministry of Justice of Ukraine registered a new Order for quality control of medicinal products in wholesale and retail trade (hereinafter - Order) that from the date of its publication cancel existing Instruction on order of quality control of medicinal products in wholesale and retail trade (hereinafter - Instructions).

Overall the Order was brought into compliance with the License terms of economic activities of wholesale and retail trade and some other acts of existing legislation. In particular, it applies the obligation on issues: of the monitoring of storage conditions of medicinal products; of checking the presence in chemists of medicinal products, circulation of which is prohibited and unregistered overdue pharmaceuticals; of the duty of existence of plan for urgent action in case of substandard medicines and so on.

The novelty of Order was the term "medicinal products of dubious quality," which establishes non-exhaustive list of inconsistency of medicinal products with current legislation. In particular, such medicinal products include products, which are stored, transported and sold in violation of applicable rules and regulations; lost marketability; do not respond the AND / MQC for visual indicators, for which the available information about the inadequacy of legislation other series of this products and the fact of the ban in other countries established; products, accompanied by inappropriate quality certificates, which have differences in the accompanying documents and violation of the conditions of production of medicinal products in pharmacies by prescription and so on.

It should be noted that the authorized person, as now, have to be appointed as both by distributor and pharmacy. However, their powers are identical, if not take into account specific conditions of trade.

The order extends the powers of the authorized person of the economic entity, while increasing qualification requirements for it. This can be predicted that the role of the internal control system of quality medicinal products in the process of trade may increase in future.

Thus, an authorized person will be able to be only a specialist with higher pharmaceutical education and professional experience of at least 2 years. An authorized person, who will be responsible for the effective management of the quality system of medicinal products in pharmacy located in countryside, will be able to be a person, who has pharmaceutical education and gained education level of specialist/junior specialist/bachelor even without professional experience.

In addition, the added responsibilities of authorized person are keeping the register of medicinal products received by the economic entity and accounting solutions of State Service of Medicinal Products of Ukraine on the quality of medicinal products with the capacity of urgent formation of movement registers of medicinal products on carrying out queries of State Service of Medicinal Products of Ukraine and its territorial bodies.

The Order stipulates, that in the case of positive result of enter control, the authorized person gives permission to produce (realise) the received lot of medicinal products. At the same time, the Order also used the term "conclusion of the enter quality control", which corresponds to the current License terms. The permit to produce (realise) is the innovation of the Order, which introduced the legislation and created inconsistent terminology.

In addition, the responsibility of the authorized person of pharmacy concludes the permission to sell medicinal products to organizational departments of pharmacy, and the responsibility of distributor’s authorized person – to permit selling of medicinal products to economic entities. Nevertheless, the form of such documents is not approved. It is also unclear is the nature of such permits in light of the fact that the economic entity in any case have to give a document on the results of enter control.

In the case of a negative result, the authorized person takes a formal note of defects, which is the reason for the return of the lot to provider.