Stage II of the implementation of the Applicant’s electronic cabinet
The State Expert Center of the Ministry of Health (the Center) announces that, starting from 03.02.2020, the second stage of using the software module of the Applicant’s personal electronic account is being introduced, which provides, under the terms of the agreement, for access to the database of adverse reactions (AR) and/or lack of efficacy (LoE) in the medical use of medicinal products (MP), including vaccines/tuberculin, that the Customer places on the Ukrainian market, in the Automated Pharmacovigilance Information System (APIS) through the “Applicant’s Electronic Account” (AEA) already created by the Customer.
Please note that the main condition for using this functionality is signing an agreement between the Customer (Applicant) and the Contractor (State Enterprise “State Expert Center of the Ministry of Health of Ukraine”).
Договір на надання послуг (далі – Договір) передбачає надання Замовнику послуг та умови припинення надання послуг з платного доступу до бази даних про ПР та/або ВЕ при медичному застосуванні ЛЗ, в тому числі вакцин/туберкуліну, які Замовник представляє на ринку України, в АІСФ через вже створений Замовником ЕКЗ, протягом 1 року з дати активації доступу Замовника до бази даних АІСФ.
These services must be used by the authorized person responsible for pharmacovigilance/contact person (hereinafter – UOVF/KOVF) appointed by the Applicant (hereinafter – the User).
The sequence of actions for activating the second functionality of an e-cabinet already created by the Applicant is provided for your attention:
- On the main page of the EKZ software module, the User indicates the wish to receive a second type of service through the EKZ, namely access to the database on adverse reactions and/or lack of efficacy in the medical use of medicinal products, including vaccines/tuberculin, that the Customer places on the Ukrainian market.
- Before concluding the Agreement, the Applicant, through the Service Center, submits a letter in which, in free form, it states its wish to obtain access to the database of AR and/or LoE in the medical use of MP, including vaccines/tuberculin, that the Customer places on the Ukrainian market, and indicates the initial data under which the User was registered in the AEA, namely: full name; position of the UOVF/KOVF; login; e-mail address; contact telephone number (hereinafter – the Letter); a Power of Attorney confirming the authority of the UOVF/KOVF, a duly certified copy of which is attached to the letter.
- After determining the number of registration certificates for medicinal products that the Applicant presents on the Ukrainian market on the date of submission of the Letter and determining the cost of services in accordance with “Cost of Information, Consulting, and Other Services Provided by the State Expert Center of the MoH”, the expert-administrator of the Pharmacovigilance Department of the Center sends this information to the e-mail address of the EKZ User.
- After the Applicant receives information on the cost of services via EKZ, the Applicant independently prints the Contract form, which is located on the DEC website https://dec.gov.ua/, and fills in all the fields and details provided for by the Contract.
- Через Сервісний центр Заявник подає Договір з пакетом документів, необхідних для підписання Договору, разом із супровідним листом, в якому зазначає перелік наданих документів, оформлених згідно вимог законодавства України.
- If there are no comments, the agreed Contract is signed by an authorized person of the Center and sealed with the Center’s seal.
- The Applicant picks up the second copy of the Agreement through the Service Center.
- The Center issues an invoice to the Applicant for payment within 3 business days from the date of conclusion of the Agreement.
- The applicant pays a 100% prepayment of the cost of services in accordance with the terms of the Agreement.
- No later than 2 working days from the date of crediting to its current account of funds received from the Applicant, the Center shall activate the Applicant's access to the database of adverse reactions and/or lack of efficacy in the medical use of medicinal products, including vaccines/tuberculin, in the AISF through the Applicant's electronic account.
