To the attention of Marketing Authorisation Holders
Notice on the Index of medicinal products for human use, 2020
Considering obligatory compliance with provisions of the Footnote under paragraph III, E, 52) of the Annex to the Order of the Minister of Health no. 888/2014 on approval of fees payable to the National Agency for Medicines and Medical Devices for activities conducted related to medicinal products for human, please be advised on the following:
By 29.11.2019, for update of the Index of medicinal products for human use 2020, Marketing Authorisation Holders (MAH) /MAH representatives shall submit to the NAMMDR the payment form related to the fee for setup and update of the Index of medicinal products for human use, available in both Romanian and English on the NAMMDR website under the heading “Forms and fees – Medicinal products for human use”, specifying the following:
– the list of all medicines included in the MAH portfolio (product name, pharmaceutical form, strength);
– the total fee amount in Euro, according to provisions of Order of the Minister of Health no. 888/2014, resulting from multiplication of the fee amount by the number of products proposed for inclusion into the Index.
Considering that respective invoices are issued for each MAH and not for each product, representatives of several MAHs shall submit a payment form for each individual MAH represented and the payment form shall specify the paying company, providing all necessary billing data and stating the currency intended.
Medicines for which the fee payment form is not submitted by 29.11.2019 and for which actual payment is not performed by 15.01.2020, are not included in the Index, i.e. shall be eliminated from the Index as of 15.01.2020.