On September 17, the draft Law of Ukraine  “On Amendments to Article 19 of the Law of Ukraine “On Medicinal Products” regarding the implementation of electronic retail trade of medicinal products was adopted in the second reading. 

After it is signed by the President of Ukraine, the document will enter into force on the day following its publication, and will be put into effect 3 months after the date of entry into force.

In accordance with the draft law, a business entity that has a license to carry out business activities in the retail trade of medicinal products can carry out retail trade of medicinal products using information and telecommunication systems remotely (electronic retail trade of medicinal products), as well as carry out their delivery to the end consumer provided the following requirements are met:

1) the licensee must be included in the list of business entities that have the right to carry out electronic retail trade of medicinal products, which is maintained and posted on the website of the licensing body;

2) information on the right of the business entity to carry out electronic retail trade in medicinal products must be contained in the Licensing Register for the production of medicinal products (under the conditions of a pharmacy), wholesale and retail trade in medicinal products of the licensing authority;

3) the website of a business entity that has the right to carry out electronic retail trade of medicinal products must contain:

• information on the contact details of the licensing body, state control bodies for the quality of medicinal products;
• a logo with a hyperlink that is displayed on each of its pages and clicking on which takes the consumer to a link to the List, which is posted on the website of the licensing authority (such a logo is used only for pharmacies included in the List);
• the option of providing consultations by a pharmacist, if necessary, when ordering medicines through the website of the pharmacy;
• the cost of delivery of the medicine.

The description, image and procedure for using the logo to identify licensees who have the right to carry out electronic trade in medicinal products are approved by the Ministry of Health;

4) the presence of its own delivery service, equipment and facilities that ensure compliance with the conditions of storage of medicines specified by the manufacturer during their delivery, or the involvement of other business entities — postal operators — on a contractual basis.

The standard form of the contract on the delivery of medicinal products to the final consumer will be established by the Government.

5) delivery of medicinal products exclusively from pharmacies included in the List.

Also, the business entity is allowed to additionally use medical information systems connected to the central database of the electronic health care system. In the case of its use and enabling the business entity to receive orders from users of such a system, such a medical information system must necessarily contain:

• a link to the website of the licensing authority, which contains information about business entities;
• the option of providing consultations by the pharmacist of the business entity, if necessary, when ordering medicines through the website of the electronic medical information system.

At the same time, electronic retail trade and delivery to the end consumer are prohibited:

• medicinal products, the sale (issuance) of which to citizens is carried out according to the prescriptions of doctors, except for the sale of such drugs according to the electronic prescription in the order established by the Ministry of Health;
• medicinal products, the circulation of which requires a license for the circulation of narcotic drugs, psychotropic substances and precursors;
• potent, poisonous, radioactive and immunobiological drugs, the list of which is determined by the Ministry of Health.

It is also prohibited to establish a mandatory minimum quantity of medicinal products and the size of the minimum order when carrying out electronic retail trade of medicinal products.

The business entity is obliged to ensure the confidentiality of personal data of consumers in accordance with the requirements of current legislation. In addition, he is responsible to the end user for preserving the quality of the medicinal product and observing the conditions of its storage specified by the manufacturer, including during the delivery to the end user of the medicinal product sold remotely, regardless of whether he makes the delivery by his own delivery service, or engages other business entities for this, and also bears administrative and criminal responsibility for violating the rules of dispensing and delivery of medicinal products in accordance with current legislation.

Business entities that are involved in the delivery of medicinal products to the final consumer on a contractual basis are also administratively and criminally responsible for violating the established requirements for the delivery of medicinal products in accordance with current legislation.

Within 3 months from the date of entry into force of this document, the Government is obliged to develop and bring regulatory acts into compliance with this law and to ensure the adoption by the Ministry of Health of all necessary normative acts for the implementation of the provisions of this law, as well as to ensure the adoption by the State Medical Service of the list of economic entities, that have the right to carry out electronic retail trade of medicinal products, and to place it in free access on their official website.